Updates

Quality Committee Event Report

We have posted a report on the “FY 2026 (53rd) GMP Case Study Workshop.”

News Release Code Compliance Promotion Committee

Announcement Regarding the “JPMA Code of Practice: Month to Promote Understanding of the JPMA Code”

Code Compliance Promotion Committee Event Report

We held the “FY 2026 Meeting of Compliance Management Officers and Practitioners.”

Regulatory Affairs Committee Event Report

We have posted a report on our participation in the “16th Annual Conference of the Society for Regulatory Science.”

Drug Evaluation Committee

“Explanation Materials on the New RMP System (October 2026), Japan Pharmaceutical Manufacturers Association Briefing Materials, and Other Documents” have been posted.

Drug Evaluation Committee

“Results of the Survey of Member Companies of the Drug Evaluation Committee Regarding the Usage of the ICF Common Template” has been posted.

Drug Evaluation Committee

"Introduction to Patient Preference Research" has been published.

News Release

Three Pharmaceutical Associations from Japan, the U.S., and Europe (
) Joint Statement on the Proposed Expansion of the Cost-Effectiveness Evaluation System

News Release Notices

The Japan Pharmaceutical Manufacturers Association to Transition to a General Incorporated Association Effective October 1, 2026
— Turning Change and Challenges into Strength. Expanding the Circle of Co-Creation. —

Code Compliance Promotion Committee

We have posted videos related to the JPMA’s Code Awareness Month.

Notices Event Report

Public and Private Sectors to Highlight the Evolution of the Japanese Market and Clinical Trial Environment at “BIO International Convention 2026”

News Release Industry Policy Committee

JPMA Announces the 4th (FY 2026) “Call for Applications for Researcher Support and Grants”

Industry Policy Committee

The “FY2026 Guidelines for the Open Call for Researcher Support and Grants” have been published.

Notices Patient Organization Collaboration Promotion Committee

We have posted the “Disclosed Information for FY 2025 Payments” under the “Transparency Guideline for Relationships Between Corporate Activities and Patient Organizations.”

Notices Code Compliance Promotion Committee

We have posted the “Disclosed Information for Fiscal Year 2025 Payments” under the “Transparency Guideline for the Relation between Corporate Activities and Medical Institutions, etc.”

Public Relations Committee Event Report

A report on the “JPMA Chairman’s Press Conference” has been posted.

ICH Project Event Report

We have posted a report on our participation in the “ICH Rio de Janeiro Meeting.”

Notices

We have posted the “Materials from the JPMA President’s Press Conference Held on July 30.”

Public Relations Committee

We have posted the report on the “19th Survey on Public Perceptions of Medicines and the Pharmaceutical Industry.”

Quality Committee Event Report

We have posted a report on the “FY 2026 (53rd) GMP Roundtable.”

Drug Evaluation Committee

"Presentation Slides: 'A Study on the Impact of the Study Group on Pharmaceutical Regulation on Post-Marketing Surveys and Other Activities' (July 11, 2026, 28th Assembly and Academic Conference of the Japanese Society for Drug Information)" has been posted.

Notices Public Relations Committee

We have published the “JPMA Newsletter, July 2026 Issue No. 230.”

Drug Evaluation Committee

We have posted “Q&A, 5th Edition: Regarding ‘Registration of Clinical Trial Status, etc.’ (Pharmaceutical and Medical Products Safety and Evaluation Committee Notice No. 0831-9, August 31, Reiwa 2).”

Drug Evaluation Committee

We have posted “The Revised Next-Generation Medical Infrastructure Act and Post-Marketing Drug Safety Surveillance: Required Measures for Pharmaceutical Companies.”

News Release

Following the Cabinet’s Approval of the “Basic Policy 2026”

Drug Evaluation Committee

"We have posted an article titled 'JPMA's Perspective on the FDA Roadmap and Related Documents'."

Pharmaceutical Counseling and Response Review Committee

"Medication Consultation Desk (for Healthcare Professionals)" has been posted.

Industry Policy Committee International Committee

"On Institutional Measures to Ensure a Stable Supply of Medicines and Other Products Necessary for Infectious Disease Control and to Promote Antimicrobial Drug Discovery" has been posted.

Drug Evaluation Committee

We have published “The Potential for Bioequivalence Evaluation Using Physiological Drug Absorption Models: The Current Status and Future Prospects of Virtual BE.”

Drug Evaluation Committee

We have posted information on the “Symposium on Pediatric Drug Development: ‘Envisioning the Future of Pediatric Drug Development—Challenges in the New Era Brought About by Amendments to the Pharmaceutical and Medical Devices Act,’ to be held on March 17, 2026.”

International Committee Event Report

We have posted an article titled “Side Event Report — 79th World Health Assembly (WHA79)”

News Release

—Making Drug Discovery and Biotechnology Japan’s Engine of Growth— In Response to the Publication of the “Working Group Roadmap of the Japan Growth Strategy Council”

News Release Public Relations Committee

Five Member Companies of the JPMA Participate in “Girls Meet STEM” — Each Company Hosts Its Own Program —

Drug Evaluation Committee

We have posted the “Guide to Creating Terms of Use for the Adverse Reaction Database (DB) Tool.”

Industry Policy Committee Event Report

Report on Participation in “Medicine Festival 2026: A Science Experience Event for Children and Adults Alike”

Industry Policy Committee Event Report

Report on the JPMA Media Forum: “The Diverse Value Brought by Innovative Medicines—Using Pediatric Acute Lymphoblastic Leukemia (ALL) as a Case Study”

Regulatory Affairs Committee

We have posted the "Survey Report on the Current Status of Application Lags in Japan (March 2026)."

Drug Evaluation Committee

"Survey Results on Initiatives for Patient and Public Involvement (PPI/E) Activities (Conducted February–March 2025)" has been posted.

Drug Evaluation Committee

"Theory and Practice of Model-Based Meta-Analysis in Drug Development" has been posted.

News Release

Top Leaders of Global Biopharmaceutical Companies Meet with Prime Minister Sanae Takaichi

Drug Evaluation Committee

We have posted information about the workshop to be held on April 16, 2026: “What Is a Lay Summary That Answers ‘What I Want to Know’?—Let’s Think About It Together from the Perspectives of Patients, Regulators, and Practitioners!”

Patient Organization Collaboration Promotion Committee

We have posted “[Interview on Participation and Collaboration (Patient Organizations)] ‘If Only This Existed!’ Changes the Future: The PAH Association.”

Drug Evaluation Committee

"Explanation of the 'Guidelines on the Handling of Information Provision Related to Clinical Trials, etc.' and Q&A" has been posted.

Drug Evaluation Committee

“Current Status of Post-Marketing Surveys Under Japan’s GPSP Ordinance: A Survey on GPSP” has been posted.

Public Relations Committee Event Report

The 45th Public Relations Seminar" report is now available.

Drug Evaluation Committee Event Report

The 149th Assembly of the Drug Evaluation Committee" is now available.

Drug Evaluation Committee

We have released the presentation materials and video from the symposium “Covariate Adjustment for Improving Statistical Efficiency in Randomized Controlled Trials.”

Notices Public Relations Committee

JPMA Newsletter May 2026 No.229" is now available.

Drug Evaluation Committee

We have published “Survey Results on Clinical Trials That Do Not Require Visits to Medical Institutions.”

Drug Evaluation Committee

"Digital Applications in Preventive Medicine and Initiatives by Pharmaceutical Companies" has been posted.

Drug Evaluation Committee

We have posted an “Explanation Video Aimed at Promoting Understanding of ICH-E6 (R3).”

Drug Evaluation Committee

We have published “Survey and Analysis on Data Utilization in jRCT and Clinical Trial Notifications Aimed at Implementing ICH M11.”

Drug Evaluation Committee

We have published “Industry Workshop Held to Implement the ‘Clinical Trial Ecosystem Industry Declaration 2025’.”

Drug Evaluation Committee

“The Dawn of the ICH E6(R3) Era: The Future of the Clinical Data Manager—How Will the Role of the Clinical Data Manager Change Through the Identification of CTQ Factors?” has been posted.

Drug Evaluation Committee

"What Constitutes Effective Communication of Pharmaceutical Information That Builds Trust" has been posted.

Drug Evaluation Committee

"Workshop for Case Evaluation Officers Held" has been posted.

Drug Evaluation Committee

"Guidelines for Preparing the 'Infectious Disease Evaluation Report' (2026 Edition)" has been published.

Drug Evaluation Committee

“Analysis of Positioning Maps for Patients Searching for Drug Information Online” has been posted.

Code Compliance Promotion Committee Event Report

The "2025 Meeting of Compliance Managers and Practitioners" was held.

Public Relations Committee Event Report

“Experiencing the ‘Moment a Drug Is Born’ at Girls Meet STEM—Female Middle and High School Students Take on the World of Drug Discovery”

News Release APAC Project

On the occasion of the 15th APAC (Asia-Pacific Association of Pharmaceutical Manufacturers and Associations) Conference

News Release APAC Project

The 15th APAC Press Conference

Drug Evaluation Committee

"A Beginner’s Guide to Using the NDB in Pharmaceutical Companies" has been posted.

Public Relations Committee

"JPMA Newsletter [Special Edition]: JPMA Holds Its First Town Hall Meeting!" has been posted.

Intellectual Property Committee Event Report

“2026 Life Sciences Intellectual Property Forum” Held

Review Board of Ethical Drug Product Information Brochure Event Report

“FY2025 Training Session for Product Information Summary Managers and Operational Managers” Held

Drug Evaluation Committee

"Results of a Survey of Pharmaceutical Companies Regarding Post-Marketing Surveillance" has been published.

Drug Evaluation Committee

"List of Companies That Have Adopted the Common Template for Explanatory Documents and Informed Consent Forms (ICF)" has been posted.

Drug Evaluation Committee

We have posted the “Case Studies on the Implementation of Cloud Systems at Medical Institutions” on the “Standard Operating Procedures, etc., for the Electronic Handling of Clinical Trial-Related Documents (2024 Edition)” page.

Patient Organization Collaboration Promotion Committee

We have posted “[Practical Interviews on Participation and Collaboration (Patient Organizations)] Patient Groups Are Like Treasure Chests! Let’s Put Our Thoughts into Words! Osaka IBD.”

Biopharmaceutical Committee

We have posted “Analysis of Application Documents for Approved Regenerative Medicine Products (Life Cycle Management Information).”

News Release Drug Evaluation Committee

"Don't Take Medical and Health Information at Face Value!" Three Organizations Produce and Release Public Awareness Materials for the General Public

Drug Evaluation Committee

"Don’t Take Medical and Health Information at Face Value!" Awareness Materials (Jointly Produced by Three Organizations) has been posted.

Quality Committee

We have posted the “Q&A Collection of Case Studies from the Commercial Production Digital Transformation (DX) Promotion Task Force (TF).”

Drug Evaluation Committee

“Handbook on Regulatory Requirements and Issuances for Digitized Information, 6th Edition” has been posted.

Drug Evaluation Committee

"The Contribution of Clinical Pharmacology to Ensuring Diversity in Drug Development" has been posted.

Drug Evaluation Committee

"Considerations for CSV Compliance When Sponsors Build DCT Systems" has been posted.

Drug Evaluation Committee

"An Overview of the FDA’s Proposed Framework for ‘Risk-Based Credibility Assessment of AI Models’" has been posted.

Industry Policy Committee

Drug Discovery Karuta | The World of Medicines Depicted in the Language of the Next Generation

International Committee

Creating the Future of Healthcare Together with Asia—Japan’s Contribution as Seen in the Partnership with Bac Mai Hospital (Vietnam)

Public Relations Committee Event Report

Report on the “JPMA Media Forum”

Drug Evaluation Committee

"Results of a Regular Survey on Patient and Citizen Engagement Activities in Corporate Drug Development" has been published.

Drug Evaluation Committee

“A Systematic Survey on RWD/RWE – FDA Approval Application Case Studies and Approaches to Challenges Using Innovative Technologies” has been published.

Drug Evaluation Committee

"Survey on Healthcare Professionals’ Needs Regarding Drug Safety Information" has been posted.

Drug Evaluation Committee

“Guidance on Filing ‘Electronic Package Inserts for Prescription Drugs’ — April 2026 Edition —” has been posted.

Notices Code Compliance Promotion Committee

Revision of the Transparency Guideline for the Relation between Corporate Activities and Medical Institutions

Industry Policy Committee

We have published the “FY2025 Selection Results” for open calls for proposals related to researcher support and grants.

Notices

We have published the “FY 2026 Business Policy, Business Plan, and Implementation Plan.”

Drug Evaluation Committee

We have published the “Report on the Survey of the Current Status of Publications in MA.”

Drug Evaluation Committee

“Toward the Utilization of Structured Data in Clinical Trial Notifications” has been posted.

Industry Policy Committee Event Report

We have posted a video and report on the “JPMA Rare Disease Day 2026 Symposium.”

Drug Evaluation Committee

We have posted the “Self-Inspection Checklist for Quality Testing, Ver. 1.”

Drug Evaluation Committee

We have posted the “Presentation Materials from the ‘Asian eCTD / Gateway System Information Symposium.’”

Drug Evaluation Committee

"Points to Note During TMF Data Migration" has been posted.

News Release

Notice Regarding the Appointment of New Officers

Drug Evaluation Committee

"Q&A Regarding Applications for Certified Users Under the Next-Generation Medical Infrastructure Act" has been posted.

Drug Evaluation Committee

We have posted the “Briefing on the Detailed Investigation Form for Adverse Event Investigations (JPMA Electronic Model).”

Distribution Appropriateness Committee

We have updated the "FAQ Regarding Changes to the Industry Standard Manual 'EDI Unified Data Format' and the 8th System Upgrade of JD-NET."

Environmental Issues Review Committee

We held the “Ministry of the Environment Model Project Results Presentation” and announced the industry’s first Scope 3 guidelines.

Drug Evaluation Committee

The English version of the report "Evolution and Advancement of Data Management in Drug Development(Executive Summary)" is now available.

Drug Evaluation Committee

"Current Status and Challenges of Database Research in MA: Comprehensive Analysis (FY 2025)" has been posted.

Patient Organization Collaboration Promotion Committee

We have posted “[Interview on Participatory and Collaborative Practices (Patient Organizations)] Small Questions Shape the Future—Opening the Door to Participation and Collaboration—Intractable Diseases Support familia Yamaguchi.”

International Committee Event Report

We have posted a report on our participation in the “5th Japan-Vietnam Joint Symposium.”

Public Relations Committee Event Report

A report on the “JPMA Chairman’s Press Conference” has been posted.

Drug Evaluation Committee

“Toward the Utilization of Wearable Devices” has been published.

Drug Evaluation Committee

“Proposed Plan for the ‘Clinical Trial Ecosystem Industry Declaration 2025 Implementation Workshop’” has been published.

International Committee

“The Path from Innovation Development to Access (IDAP)” has been posted.

Drug Evaluation Committee

"Information Required for Companies to Utilize Disease Registries and Its Background" has been posted.

Notices

"DATA BOOK 2026" has been released.

Drug Evaluation Committee

"Survey on Communication Challenges When Introducing DCTs" has been posted.

Drug Evaluation Committee

"Presentation Materials for Part 1 of the FY2025 Clinical Evaluation Subcommittee Assembly" has been posted.

Notices

"Materials from the JPMA President’s Press Conference Held on February 19" have been posted.

Regulatory Affairs Committee

We have posted the "Report on the Results of a Survey Regarding Companies' Current Perceptions of Face-to-Face Consultations Conducted by the NIH (February 2026)."

Drug Evaluation Committee

We have released the pre-recorded video for the symposium “Covariate Adjustment for Improving Statistical Efficiency in Randomized Controlled Trials.”

Drug Evaluation Committee

We have posted “Impact of Notices Related to the ‘Study Group on the Ideal Form of Pharmaceutical Regulations for Strengthening Drug Discovery Capabilities and Ensuring Stable Supply,’ as Revealed by Survey Results in the Pharmaceutical Industry.”

Patient Organization Collaboration Promotion Committee

We have updated “Reference: Association for Creating a Society Where Everyone Has Easy Access to Clinical Trials.”

Biopharmaceutical Committee Event Report

We have posted a report on our participation in “CMC Strategy Forum Japan 2025.”

News Release Industry Policy Committee

Regarding “Recommendations on Intractable and Rare Diseases Based on a Survey of Healthcare Professionals’ Challenges”

Drug Evaluation Committee

We have posted the “Video of Dr. Chieko Ishiguro’s Lecture: Hands-On Workshop on Utilizing Medical Information Databases in PV Activities.”

Notices Public Relations Committee

JPMA Newsletter No. 228

International Committee Event Report

"The 3rd Neglected Tropical Diseases Contest" to Be Held

Drug Evaluation Committee

We have posted the “Announcement: Symposium on Pediatric Drug Development, March 17, 2026.”

International Committee

INCATE’s website featured an article on the webinar “Toward Building a Global Community to Promote Antimicrobial R&D.”

Public Relations Committee Event Report

Sendenkaigi Award: Junior High and High School Student Division—First Judging Report

Public Relations Committee Event Report

We have posted a report on the “Joint Press Briefing” held by the JPMA and AMED.

Drug Evaluation Committee

“JPMA Q&A on the Clinical Research Act, Enforcement Regulations, and Related Matters” has been posted.

Drug Evaluation Committee

"QMS in Pharmacovigilance" has been posted.

ICH Project Event Report

A report on participation in the “ICH Singapore Meeting” has been posted.

Industry Policy Committee Event Report

We have posted a report on the “5th Economic Security Seminar.”

Drug Evaluation Committee

"Mapping of Clinical Trial-Related Documents in the TMF Reference Model (Revised Edition)" has been posted.

Notices

New Year’s Greetings

News Release

In response to the FY2026 (Reiwa 8) Drug Price System Reform and Cost-Effectiveness Evaluation System Reform

Drug Evaluation Committee Event Report

"148th Assembly of the Drug Evaluation Committee" has been posted.

Drug Evaluation Committee

"Information on the Asian eCTD / Gateway System" has been posted.

Quality Committee Event Report

We have posted a report on the “FY2025 (52nd) GMP Case Study Workshop.”

Drug Evaluation Committee

"Survey Results on Information Dissemination Activities When Revising Precautions for Use" has been posted.

International Committee Event Report

"Regular Meeting with the German Association of Research-Based Pharmaceutical Companies (vfa)" Held

International Committee Event Report

Held a Special Session at the “12th Nikkei-FT Infectious Diseases Conference”

News Release

Joint Statement by Three Pharmaceutical Associations from Japan, the U.S., and Europe: Opinions on the FY2026 (Reiwa 8) Drug Pricing System Reform and Cost-Effectiveness Evaluation System Reform

Drug Evaluation Committee

"Reflections on the First 10 Years Since the Introduction of the RMP System from the Pharmaceutical Industry’s Perspective" has been posted.

Drug Evaluation Committee

"Presentation Slides from the eCTD v4 Implementation Promotion Symposium (JPMA Presentation)" have been posted.

Drug Evaluation Committee

"DX Presentation Slides (19th Assembly of the Japanese Society of Pharmaceutical Sciences)" has been posted.

Drug Evaluation Committee

“Preliminary Study on the Application of AI to Quality Control in Clinical Trials” has been posted.

Research and Development Committee

“R & D Needs of R & D Committee Member Companies” has been updated.

Drug Evaluation Committee

"Data Integration Concept: Data Integration from the Perspective of Overseas Regulations" has been posted.

Drug Evaluation Committee

"Guidelines for Conducting Post-Marketing Database Surveys - November 2025 Edition" has been posted.

Drug Evaluation Committee

"Evolution and Advancement of Data Management in Pharmaceutical Development" has been posted.

APAC Project Event Report

Visited three Southeast Asian countries in preparation for the “15th Asia Pharmaceutical Association Cooperation Conference (APAC).”

Public Relations Committee Event Report

We have posted a report on the “44th Public Relations Seminar.”

Drug Evaluation Committee

"RMP Presentation Slides (27th Annual Meeting of the Japanese Society for Pharmaceutical Information)" has been posted.

News Release Drug Evaluation Committee

Regarding the Release of the Joint Statement “Clinical Trial Ecosystem Industry Declaration 2025”

Biopharmaceutical Committee Event Report

We have posted a report on the hosting and participation in “BioJapan 2025.”

Drug Evaluation Committee

We have posted the “Guidelines for Re-evaluation and Compliance Surveys (Ver. 2.1, created in October 2025).”

Regulatory Affairs Committee

We have posted the "Report on the Results of a Survey Regarding the Review Status of New Drugs and New Regenerative Medical Products at the Pharmaceuticals and Medical Devices Agency – January 2025 Survey."

International Committee Event Report

We have posted a “Report on the Side Event Held During the UN Assembly.”

Distribution Appropriateness Committee

We have updated the "FAQ Regarding Changes to the Industry Standard Manual 'EDI Unified Data Format' and the 8th System Upgrade of JD-NET."

Drug Evaluation Committee

We have posted the presentation slides titled “Survey of RMP Use Cases and Compilation of Case Studies.”

APAC Project Event Report

“Preparations for the 15th Asia Pharmaceutical Association Cooperation Conference (APAC)” has been posted.

Drug Evaluation Committee

"List of Companies That Have Adopted the Common Template for Explanatory Documents and Informed Consent Forms (ICF)" has been posted.

Notices International Committee

We have posted an announcement regarding the webinar “Toward the Formation of a Global Community to Promote Antimicrobial R&D.”

Drug Evaluation Committee

We have posted the “Guidance on eCTD v4 Preparation, Version 1.0.”

International Committee

We have created a cover letter template that can be used under the simplified review system in the Asia region.

News Release Public Relations Committee

We won third place in the “My CareerStudy Course Contest 2025.” JPMA’s video course for undergraduate students received high praise from student judges.

Drug Evaluation Committee

We have posted “Q&A on Document Reviews for Quality and Nonclinical Compliance.”

Drug Evaluation Committee

"Impact of ICH M11 Implementation on Drug Development" has been posted.

Notices Public Relations Committee

"JPMA Newsletter No. 227" has been published.

Notices

We have published interview articles with the Chairpersons of the “ Toward Realizing the JPMA's Vision for 2035.”

Drug Evaluation Committee

We have posted the “Survey Report on Promoting the Use of eSources, Such as Electronic Medical Records.”

Drug Evaluation Committee

We have posted the “RMP Training Slides for Medical Representatives (Revised August Reiwa 7).”

International Committee Event Report

We have posted a report on the JPMA Media Forum titled “Two Major Challenges in Infectious Disease Control: Considering Measures Against Antimicrobial-Resistant Bacteria and a Correct Understanding of Vaccination.”

News Release

On the Inauguration of New Prime Minister Sanae Takaichi

Drug Evaluation Committee

"DX Presentation Slides (58th Academic Conference of the Japan Pharmacists Association)" has been posted.

Regulatory Affairs Committee Event Report

We have posted a report on our participation in the "15th Annual Meeting of the Society for Regulatory Science."

Biopharmaceutical Committee Event Report

Chairman Miyashira spoke at the BioJapan 2025 Luncheon Seminar titled “Tackling Challenges in Access to Medicines: Public-Private Co-creation.”

Event Report

Chairman Miyashira spoke at the BioJapan 2025 Luncheon Seminar titled “Tackling Challenges in Access to Medicines: Public-Private Co-creation.”

News Release Code Compliance Promotion Committee

Announcement Regarding the “JPMA Code of Practice: Month to Promote Understanding of the JPMA Code”

News Release

Participation in the “Kusuri Visionary Conference 2025”
Expanding the Circle of Stakeholders and Engaging in Discussions Toward Co-Creation

Notices

We have posted “My Theory of Leadership” from the Nikkei Shimbun.

Drug Evaluation Committee

We have posted the “2025 Industry Declaration on the Clinical Trial Ecosystem Regarding Quality Issues.”

Drug Evaluation Committee

"List of Companies That Have Adopted the Common Template for Explanatory Documents and Informed Consent Forms (ICF)" has been posted.

Code Compliance Promotion Committee Event Report

We have posted a report on the “FY2025 Meeting of Code Management Officers and Practitioners.”

Patient Organization Collaboration Promotion Committee

We have updated “Reference: Association for Creating a Society Where Everyone Has Easy Access to Clinical Trials.”

Drug Evaluation Committee

"How to Use Simulation in Bayesian Trial Design" has been posted.

Drug Evaluation Committee

We have posted the “Survey Report on Drugs Designated Under the Pioneering Drug Designation System.”

Drug Evaluation Committee

We have published the “List of Companies That Have Adopted the Common Template for Informed Consent Forms (ICF).”

Notices Code Compliance Promotion Committee

Regarding the Publication of the Book “JPMA Code of Practice (Revised May 2025)”

The Office of Pharmaceutical Industry Research

[Nikkan Yakugyo Series “Toward an Era of Co-creation” <17>] An interview with Policy Research Institute Director Yamada published in Nikkan Yakugyo.

Research and Development Committee

[Nikkan Yakugyo Series “Toward an Era of Co-Creation” (Part 16)] An article featuring an interview with Mr. Tsukahara, Chairperson of the Research and Development Committee, published in Nikkan Yakugyo has been posted.

Biopharmaceutical Committee Event Report

We have posted a report on the “JPMA Media Forum.”

ICH Project

ICH Q3E " Draft Guideline for Extractables and Leachables" public meeting" is now available.

Drug Evaluation Committee

“Scientific Discussions Learned from the FDA Review Report” has been published.

Notices Research and Development Committee

We have published “Scientific and Practical Requirements for Drug Candidates Sought by Companies: Regarding the Description in the Target Product Profile (TPP).”

International Committee

[Nikkan Yakugyo Series “Toward an Era of Co-creation” <15>] An interview with Dr. Murakami, Chairperson of the International Committee, was published in Nikkan Yakugyo.

Intellectual Property Committee

[Nikkan Yakugyo Series “Toward an Era of Co-creation” (14)] An interview with Mr. Okumura, Chairperson of the Intellectual Property Committee, has been published in Nikkan Yakugyo.

Drug Evaluation Committee

[Nikkan Yakugyo Series “Toward an Era of Co-Creation” <3>] An interview with Mr. Nakaji, Chairperson of the Pharmaceutical Evaluation Committee, was published in Nikkan Yakugyo.

Biopharmaceutical Committee

[Nikkan Yakugyo Series “Toward an Era of Co-Creation” <13>] An interview with Chairperson Kurata of the Biopharmaceuticals Committee was published in Nikkan Yakugyo.

Patient Organization Collaboration Promotion Committee

[Nikkan Yakugyo Series “Toward an Era of Co-Creation” (12)] An interview with Chairperson Misawa of the Patient Organization Collaboration Promotion Committee was published in Nikkan Yakugyo.

Pharmaceutical Counseling and Response Review Committee

[Nikkan Yakugyo Series “Toward an Era of Co-Creation” (11)] An interview with Mr. Wakasugi, Chairperson of the Consumer Consultation Review Committee, was published in Nikkan Yakugyo.

Review Board of Ethical Drug Product Information Brochure

[Nikkan Yakugyo Series “Toward an Era of Co-Creation” <10>] An interview with Mr. Kondo, Chairperson of the Review Board of Ethical Drug Product Information Brochure, was published in Nikkan Yakugyo.

News Release

Notice Regarding the Appointment of New Officers

Quality Committee

[Nikkan Yakugyo Series “Toward an Era of Co-Creation” <8>] An interview with Mr. Kawashima, Chairperson of the Quality Committee, was published in Nikkan Yakugyo.

Public Relations Committee

[Nikkan Yakugyo Series “Toward an Era of Co-Creation” <9>] An interview with Mr. Tada, Chairperson of the Public Relations Committee, was published in Nikkan Yakugyo.

International Committee Event Report

A report on participation in the “3rd Japan-Malaysia Pharmaceutical Regulatory Symposium” has been posted.

News Release Public Relations Committee

[For Elementary School Students and Their Parents] Perfect for the fall long weekend! Hands-on events are being held at the National Museum of Science and Technology. “JPMA Kusurium Lab 2025 Fall” offers a fun way to learn about medicine. A social media campaign offering free invitations is also underway.

Code Compliance Promotion Committee

[Nikkan Yakugyo Series “Toward an Era of Co-Creation” <7>] An interview with Mr. Ouchi, Chairperson of the Code and Compliance Promotion Committee, has been published in Nikkan Yakugyo.

ICH Project

[Nikkan Yakugyo Series “Toward an Era of Co-Creation” (6)] An interview with Mr. Yokota, Chairperson of the ICH Project, was published in Nikkan Yakugyo.

Environmental Issues Review Committee

[Nikkan Yakugyo Series “Toward an Era of Co-Creation” (5)] An interview with Mr. Arima, Chairperson of the Environmental Issues Review Committee, was published in Nikkan Yakugyo.

Regulatory Affairs Committee

[Nikkan Yakugyo Series "Toward an Era of Co-creation" (Part 4)] An interview with Chairperson Kashitani of the Pharmaceutical Affairs Committee was published in Nikkan Yakugyo.

Patient Organization Collaboration Promotion Committee

We have updated “Reference: Association for Creating a Society Where Everyone Has Easy Access to Clinical Trials.”

Industry Policy Committee Event Report

An article titled “JPMA Members Participate in the DIA 2025 Global Annual Meeting, Sharing Their Initiatives to Address Drug Lag and Loss Issues with the World” has been published.

Notices Public Relations Committee

We have posted the “Science and Technology Museum ‘JPMA Kusurium Laboratory 2025 Fall’ Invitation Campaign!”

Distribution Appropriateness Committee

[Nikkan Yakugyo Series “Toward an Era of Co-Creation” (2)] An interview with Mr. Kumagai, Chairperson of the Distribution Optimization Committee, was published in Nikkan Yakugyo.

Industry Policy Committee

[Nikkan Yakugyo Series “Toward an Era of Co-Creation” (1)] An interview with Mr. Iwashita, Chairperson of the Industrial Policy Committee, was published in Nikkan Yakugyo.

Notices Public Relations Committee

We have published “Understanding the Pharmaceutical Industry Through Manga: ‘Open Up! The World of Medicine Connecting to the Future.’”

Notices

We have posted a “Newspaper Advertisement.”

Drug Evaluation Committee

We have posted information on “Model Credibility Assessment in Pharmaceutical Development.”

Drug Evaluation Committee

We have posted “Tips for Signal Management Activities in Japan.”

Drug Evaluation Committee

We have posted the “Survey Results on the Preparation and Sharing of Clinical Trial Results.”

News Release Industry Policy Committee

Regarding the JPMA’s 3rd (FY 2025) “Open Call for Researcher Support and Grants”

Notices Patient Organization Collaboration Promotion Committee

We have updated the “Disclosed Information for FY 2024 Payments” in the “Transparency Guideline for Relationships Between Corporate Activities and Patient Organizations.”

Notices Code Compliance Promotion Committee

We have updated the “Disclosed Information for FY 2024 Payments” in the “Transparency Guideline for the Relation between Corporate Activities and Medical Institutions, etc.”

Drug Evaluation Committee

We have posted the “Pharmacovigilance Regulatory Investigation Report Form.”

Drug Evaluation Committee

We have updated the “List of Companies That Have Adopted the Common Template for Explanatory Documents and Informed Consent Forms (ICF).”

Notices

We have posted JPMA’s Vision for 2035 (English Version.)

Notices

We have posted JPMA’s Vision for 2035 (English Version.)

Drug Evaluation Committee

We have posted the “DX Presentation Slides (16th Annual Meeting of the Japanese Society for Pharmaceutical Medicine).”

International Committee Event Report

We have posted a report on the “6th Japan-Korea Symposium on Pharmaceutical Regulations.”

Drug Evaluation Committee

"Clinical Trial 119 Lecture" has been posted.

News Release Public Relations Committee

JPMA Sponsors the Sendenkaigi Award for Junior and Senior High School Students — Creating a Future for Life Together with the Young Generation Who Will Shape Tomorrow —

Drug Evaluation Committee

We have posted the workshop materials titled “Smooth Submission of Electronic Regulatory Data and Effective Utilization of CDISC-Compliant Data”: “Inquiries Regarding Electronic Regulatory Data” and “Report on Survey Results: Handling of Deviations and Case Acceptance/Rejection.”

Drug Evaluation Committee

We have updated the “List of Companies That Have Adopted the Common Template for Explanatory Documents and Informed Consent Forms (ICF).”

Public Relations Committee

We have published the “Senden Kaigi Award: Junior and Senior High School Student Division—Assignment Orientation.”

Notices Public Relations Committee

“JPMA Newsletter No. 226” has been published.

International Committee

We have compiled a survey report on the issue of antibiotic-resistant bacteria.

International Committee

"The Front Lines of the Antimicrobial Resistance (AMR) Issue: Two Oncologists Discuss the Current Situation and Challenges" has been posted.

Drug Evaluation Committee

We have posted “Case Studies on the Use of RMPs and RMP Materials—Primarily for Dispensing Pharmacies.”

ICH Project

ICH M4Q(R2) "Guideline for the common technical document for the registration of pharmaceutical for human use" public meeting is now available.

News Release Environmental Issues Review Committee

Selected for the Ministry of the Environment’s “Model Project to Promote Decarbonization Across the Entire Value Chain” — 12 Companies Participate to Develop Common CO2 Emissions Calculation Rules for the Pharmaceutical Industry

Drug Evaluation Committee

We have published “Guidelines for the Efficient Preparation of Regulatory Documents (CSR and CTD [Clinical Part]) in Response to Environmental Changes.”

Industry Policy Committee

We have published “Delivering Essential Medicines to Patients—JPMA Calls on the Government to Strengthen Support for Unapproved Drugs.”

Drug Evaluation Committee

“Presentation Slides: ‘Current Status and Challenges of Post-Marketing Surveys in Japan—GPSP Questionnaire Survey’ (July 5, 2025, 27th Assembly and Academic Conference of the Japanese Society for Pharmaceutical Information)” has been posted.

Drug Evaluation Committee

“DX Presentation Slides (27th Annual Meeting of the Japanese Society for Pharmaceutical Information)” has been posted.

ICH Project

ICH E21"Inclusion of Pregnant and Breastfeeding individuals in Clinical Trials (Draft)" public meeting meeting " is now available.

Drug Evaluation Committee

“Patient Awareness Leaflet on Post-Marketing Surveillance” has been posted.

Drug Evaluation Committee

"RMP Follow-up Survey (1st Interim Results)" has been posted.

Drug Evaluation Committee

We have updated the “Guidance on Preparing Adverse Event Reports for Combination Products Classified as Pharmaceuticals (2025 Edition).”

Drug Evaluation Committee

"English Version of the Nonclinical Checklist and Q&A" has been posted.

Drug Evaluation Committee

"Assessment of Validation Required for the Use of Digital Biomarkers as Primary Endpoints in Clinical Trials" has been posted.

Drug Evaluation Committee

We have updated the “List of Companies That Have Adopted the Common Template for Explanatory Documents and Informed Consent Forms (ICF).”

International Committee Event Report

We held a “Meeting with the Pharmaceuticals and Medical Devices Agency (PMDA), the National Cancer Center (NCC), and the National Institute of Health and Crisis Management (JIHS)” to improve the clinical trial environment in Asia.

Drug Evaluation Committee

We have posted “Covariate Adjustment in Randomized Controlled Trials Based on FDA Guidance.”

International Committee Event Report

We have posted information on the WHA78 side event held in Geneva titled “Strengthening Strategic Partnerships to Combat Infectious Diseases (Vector-Borne Diseases, Neglected Tropical Diseases, and Emerging Infectious Diseases).”

Public Relations Committee Event Report

Report on the “43rd Public Relations Seminar” has been posted.

ICH Project Event Report

We have posted a report on the “ICH Madrid Meeting.”

ICH Project

We have posted an announcement for the “51st ICH Public Meeting.”

APAC Project Event Report

We have posted a report on the “14th APAC (Asia Pharmaceutical Association Conference).”

Drug Evaluation Committee

We have posted “The Dawn of the ICH E6 (R3) Era: The Future of the Clinical Data Manager.”

Drug Evaluation Committee

We have posted “What Kind of Patient Experience Data Is Useful for Decision-Making in Drug Development?” to be held on June 13, 2025.

Drug Evaluation Committee

"April 2, 2025: ‘R’ Workshop" has been posted.

News Release

Following the Cabinet’s Approval of the “Basic Policy 2025”

Drug Evaluation Committee Regulatory Affairs Committee Event Report

We have posted a report on the “FY2025 Joint Assembly of the Drug Evaluation Committee and the Regulatory Affairs Committee.”

Public Relations Committee Event Report

A report on the “JPMA Chairman’s Press Conference” has been posted.

Drug Evaluation Committee

"Guidelines for Medical Writers on Preparing Regulatory Documents in Response to Changes in the Digital Technology Environment, Including Generative AI" has been posted.

Drug Evaluation Committee

"Comparison of Guidance on the Utilization of RWD/RWE in Japan and the U.S." has been posted.

Drug Evaluation Committee

We have updated the “List of Companies That Have Adopted the Common Template for Explanatory Documents and Informed Consent Forms (ICF).”

Drug Evaluation Committee

We have updated the “Standard Operating Procedures, etc., for the Electronic Handling of Clinical Trial-Related Documents (2024 Edition).”

ICH Project

We have posted the “Guideline Workshops on ICH Q1 ‘Guideline on Stability Testing of Drug Substances and Drug Products (Draft)’ (Step 2 Document).”

Event Report

Chairman Kinoshita spoke on a panel hosted by the U.S. publication “Endpoints News.”

Notices

We have posted the presentation video from the “Press Conference by the Chairman of the JPMA” held on May 22.

Drug Evaluation Committee

We have updated the “Roundtable Report on Challenges and Priorities in the Utilization of RWD/RWE.”

News Release Code Compliance Promotion Committee

Revision of the JPMA Code of Practice

Drug Evaluation Committee

We have posted “The Current Status and Challenges of Digital Therapeutics (DTx) in Japan.”

Notices Public Relations Committee

We have posted the “JPMA Guide 2025.”

Notices

We have posted the “Materials from the JPMA President’s Press Conference Held on May 22.”

News Release

Notice Regarding the Appointment of New Officers

Drug Evaluation Committee

We have updated the “List of Companies That Have Adopted the Common Template for Explanatory Documents and Informed Consent Forms (ICF).”

Event Report

Executive Director Ishida spoke at an online event for students.

Patient Organization Collaboration Promotion Committee

We have updated “Reference: Association for Creating a Society Where Everyone Has Easy Access to Clinical Trials.”

Notices

“Newspaper and Digital Advertising” has been updated.

Drug Evaluation Committee

We have published the “Reference Guide on Clinical Development of Regenerative Medicine Products.”

Notices Public Relations Committee

"JPMA Newsletter No. 225" has been published.

Drug Evaluation Committee

We have posted “Q&A Regarding the ICF Common Template.”

Drug Evaluation Committee

We have posted the “Handbook on Regulatory Requirements and Issuances for Electronic Information, 5th Edition.”

Notices

“Newspaper and Digital Advertising” has been updated.

Drug Evaluation Committee

"Utilizing Patient Experience Data for Patient-Focused Drug Development: For Decision-Making Based on Patients’ Voices" has been posted.

Drug Evaluation Committee

We have updated the “List of Companies That Have Adopted the Common Template for Explanatory Documents and Informed Consent Forms (ICF).”

Code Compliance Promotion Committee Event Report

We have posted a report on the “FY2024 Training Session for Product Information Summary Managers and Operational Managers.”

International Committee Event Report

A report on the “Regular Meeting with the French Pharmaceutical Industry Association (Leem)” has been posted.

News Release APAC Project

Following the 14th Asia Pharmaceutical Association Cooperation Conference (APAC)

News Release APAC Project

We have posted the “Press Conference Materials for the 14th Asia Pharmaceutical Association Cooperation Conference (APAC), Held on April 23.”

International Committee

We have released the video content “Messages from Senior Pharmacists to Pharmacy Students Aspiring to Become Pharmacists.”

Drug Evaluation Committee

We have updated the “List of Companies That Have Adopted the Common Template for Explanatory Documents and Informed Consent Forms (ICF).”

Drug Evaluation Committee

“Model Credibility Assessment in Pharmaceutical Development” has been posted.

Industry Policy Committee Event Report

We have posted a report on the “JPMA Media Forum.”

Code Compliance Promotion Committee Event Report

We have posted the report on the “FY2024 Meeting for Compliance Management Officers and Practitioners.”

Drug Evaluation Committee

We have updated the “List of Companies That Have Adopted the Common Template for Explanatory Documents and Informed Consent Forms (ICF).”

Drug Evaluation Committee

We have republished “Patient-Reported Outcomes in Clinical Trials: A Guide to Using PROs for Clinical Development Professionals.”

Public Relations Committee Event Report

We have published “Future Drug Researchers in the Making!? The ‘JPMA Kusurium Laboratory’ Experience Event Is a Huge Hit.”

Industry Policy Committee

We have published the “FY2024 Selection Results” for open calls related to researcher support and grants.

Drug Evaluation Committee

We have posted information on the event for medical institutions, “Symposium on Promoting the Use of the ICF Common Template: Case Studies of Implementation at Medical Institutions” (Online: February 26, 2025).

Drug Evaluation Committee

We have posted the “Notice Regarding Revisions to the Common Template for Explanatory and Consent Documents (ICF).”

Biopharmaceutical Committee

"Analysis of Application Documents for Approved Regenerative Medicine Products (Life Cycle Management Information)" has been updated.

Notices

We have published the FY2025 “Business Policy, Business Plan, and Implementation Plan.”

Drug Evaluation Committee

We have posted the results of the survey (FY 2024) regarding the domestic implementation of ICH M11 “Electronic Structured and Harmonized Clinical Trial Protocol (CeSHarP).”

International Committee

#AlwaysInnovating: Pharmaceutical Industry Facts & Figures has been posted.

Intellectual Property Committee Event Report

We have posted the report on the “2025 Life Sciences IP Forum.”

Drug Evaluation Committee

"Presentation Materials for Part 2 of the FY2024 Clinical Evaluation Subcommittee Assembly" has been posted.

ICH Project

We have posted the “Guideline Workshops for the Draft ICH M13B Guideline ‘Bioequivalence of Immediate-Release Oral Solid Dosage Forms—Biowaivers for Additional Content.’”

ICH Project

We have posted the “Briefing on ICH M15 ‘General Principles on Model-Informed Drug Development (Draft)’.”

Event Report

A report on the “JPMA Chairman’s Press Conference” has been posted.

Notices Event Report

A report on the “JPMA Chairman’s Press Conference” has been posted.

Drug Evaluation Committee

We have posted information on the “Southeast Asia and East Asia International Collaborative Clinical Research Alliance (ARISE) Briefing Session” held on April 2, 2025.

Drug Evaluation Committee

We have posted the “Guidance for Preparing Periodic Reports on Infectious Diseases” (2025 Revised Edition).

Biopharmaceutical Committee Event Report

We have posted a report on our participation in the “CMC Strategy Forum Japan 2024.”

International Committee Event Report

A report on the “Regular Meeting with the European Federation of Pharmaceutical Industries and Associations (EFPIA)” has been posted.

Drug Evaluation Committee

Presentation materials from the “Symposium on Promoting eCTD v4 Implementation,” held in November 2024, have been posted.

Drug Evaluation Committee

We have posted “How to Proceed with the Consideration of Post-Marketing Database Surveys Using Registries.”

Drug Evaluation Committee

We have updated the “List of Companies That Have Adopted the Common Template for Explanatory Documents and Informed Consent Forms (ICF).”

Drug Evaluation Committee

We have posted information regarding the “Asia Cancer Clinical Trials Network (ATLAS Project) Information Session” held on February 25, 2025.

International Committee Event Report

We have posted a report on the “Second Neglected Tropical Diseases Contest.”

Industry Policy Committee

We have posted “Information on the Diverse Values of Pharmaceuticals.”

Notices Code Compliance Promotion Committee

We have updated the “Transparency Guideline for the Relation between Corporate Activities and Medical Institutions”

Notices

We have published “DATA BOOK 2025.”

Notices

We have posted the presentation video from the “Press Conference by the Chairman of the JPMA” held on February 26.

Industry Policy Committee Event Report

We have posted the “Report on the JPMA’s Rare Disease Day 2025 Symposium.”

Notices

We have posted the “Materials for the JPMA Chairman’s Press Conference Held on February 26.”

News Release

Regarding the “JPMA’s Vision for 2035” and “JPMA’s Policy Proposals for 2025”

News Release Public Relations Committee

Regarding the “18th Survey on Public Perceptions of Medicines and the Pharmaceutical Industry”

Public Relations Committee

We have posted the report on the results of the “18th Survey on Consumer Attitudes Toward Medicines and the Pharmaceutical Industry.”

News Release Public Relations Committee

[For Elementary School Students and Their Parents] Aim to Become a Medicines Researcher This Spring Break! Announcement of the “JPMA Kusurium Laboratory,” a hands-on event where you can learn various facts about medicines

Public Relations Committee

We have posted the report on the results of the “18th Survey on Consumer Attitudes Toward Medicines and the Pharmaceutical Industry.”

Drug Evaluation Committee

“Considerations for Simulation in Planning Adaptive Designs” has been updated.

Drug Evaluation Committee

“Points to Consider When Conducting Indirect Comparisons in Cost-Effectiveness Evaluations” has been published.

Drug Evaluation Committee

"List of Companies That Have Adopted the Common Template for Explanatory Documents and Informed Consent Forms (ICF)" has been posted.

Drug Evaluation Committee

“Easy to Understand! A Guide to Watching the PMDA’s ‘Video on Re-examination Compliance Surveys’” has been posted.

Drug Evaluation Committee

“Handling Missing Data in Clinical Trials” has been republished.

Drug Evaluation Committee

We have posted information on the lecture to be held on January 23, 2025: “QMS in Medical Institutions and Clinical Trial Sponsors and Approaches to Its Implementation—The Basics of QMS and Implementation That Everyone Can Understand: The Importance of ‘Fostering a Culture of Quality’ and ‘Exercising Leadership’.”

Notices Public Relations Committee

We have posted “Textbook: Pharmaceutical Industry 2024–2025.”

Drug Evaluation Committee

We have posted information on the “ICH M10 Guideline Workshops” held online on April 16, 2025.

Drug Evaluation Committee

We have posted the “Guidance for Preparing a Pharmaceutical Risk Management Plan (J-RMP) – January Reiwa 7 Edition.”

Research and Development Committee

“R & D Needs of R & D Committee Member Companies” has been updated.

Notices Public Relations Committee

"JPMA Newsletter No. 224" has been published.

Drug Evaluation Committee

“Brochure: What Are Medical Affairs (MA) in Pharmaceutical Companies?” has been posted.

Notices Distribution Appropriateness Committee

We have updated the "FAQ Regarding Changes to the Industry Standard Manual 'EDI Unified Data Format' and the 8th System Upgrade of JD-NET."

News Release Drug Evaluation Committee

Release of an Awareness Video on the Utilization of Health and Medical Data

Drug Evaluation Committee

"Utilizing Real-World Data in Cost-Effectiveness Analysis" has been posted.

Drug Evaluation Committee

We have posted the announcement for the “Joint CRC/CRA Workshop in Kansai: Consistent Quality Management Connecting Medical Institutions and Clinical Trial Sponsors—An Interactive Workshop for CRCs and CRAs.”

Drug Evaluation Committee

We have posted event details for the “Workshop to Promote QMS Implementation—Experience Approaches to Organizational Challenges” for pharmaceutical companies and CROs (In-person: March 4, 2025).

APAC Project Event Report

“Visit to Four Southeast Asian Countries in Preparation for the 14th Asia Pharmaceutical Association Conference (APAC)” has been posted.

Notices APAC Project

A new “APAC Project” section has been added to the Committees page.

Drug Evaluation Committee

We have posted the “FY2024 OSS Usage Survey Report.”

ICH Project Event Report

We have posted a report on our participation in the “ICH Montreal Meeting.”

Drug Evaluation Committee

We have posted event details for “Symposium on Promoting the Use of the ICF Common Template: Case Studies of Implementation at Medical Institutions” (Online: February 26, 2025).

International Committee Event Report

We have posted a report on the “Regular Meeting with the German Association of Research-Based Pharmaceutical Companies (vfa).”

International Committee Event Report

We have posted a report on the special session held at the “11th Nikkei-FT Infectious Diseases Conference.”

Public Relations Committee Event Report

We have posted a report on the “42nd Public Relations Seminar.”

Drug Evaluation Committee

We have posted information on the “February 5, 2025 Single IRB Workshop.”

Notices

We have posted the “2025 New Year’s Greeting from the President of the JPMA.”

News Release

Regarding the FY2025 (Reiwa 7) Drug Price Revision

International Committee Event Report

We have posted “Regular Meeting Held with the Association of the British Pharmaceutical Industry (ABPI).”

Industry Policy Committee Event Report

We have posted a report on the “4th Economic Security Seminar.”

International Committee Event Report

We have posted a report on the “12th Japan-Taiwan Pharmaceutical Exchange Conference.”

Drug Evaluation Committee

Clinical Trials 119: Q&A Update “On the Permissibility of Using Data from Cases Where Consent for a Clinical Trial Has Been Withdrawn”

Biopharmaceutical Committee Event Report

We have posted a report on the organization and participation in “BioJapan 2024.”

Drug Evaluation Committee

We have posted a discussion on pseudonymization techniques used when creating pseudonymized information.

ICH Project

We have updated the “50th ICH Public Meeting (Online).”

Drug Evaluation Committee

"RMP Presentation Slides (34th Annual Meeting of the Japanese Society of Clinical Pharmacy)" have been posted.

International Committee Event Report

We have posted a report on the “7th Japan-India Symposium on Medical Product Regulation.”

Environmental Issues Review Committee

“Collaboration with Business Partners on Decarbonization” has been posted.

Drug Evaluation Committee Event Report

We have posted a report on the “FY2024 Drug Evaluation Committee Assembly Symposium.”

Patient Organization Collaboration Promotion Committee

We have updated “Reference: Association for Creating a Society Where Everyone Has Easy Access to Clinical Trials.”

Drug Evaluation Committee

"Section Chief’s Notice: ‘Regarding the Use of Common Templates for Informed Consent Forms and Explanatory Documents in Clinical Trials (Request)’ (July 4, Reiwa 6) and the English Translation of Said Notice" has been posted.

Drug Evaluation Committee

"Reference English Translations of the Common Templates for Informed Consent Forms (ICF) and Awareness-Raising Pamphlets" have been posted.

Industry Policy Committee

"Educational Materials on Whole-Genome Analysis and Genomic Medicine" have been posted.

Drug Evaluation Committee

We have posted two “Translations: FDA Guidance Documents Related to RWD.”

News Release

We have posted “Participation in the ‘Drug Visionary Conference 2024’
Aiming for Dialogue and Co-creation Among Diverse Stakeholders.”

Drug Evaluation Committee

We have posted “Points to Note When Conducting Trials Applying ICH E19 ‘Selective Approaches to Safety Data Collection in Certain Clinical Trials Conducted in Late Development or Post-Approval’—Primarily from a Data Management Perspective.”

Notices

We have posted the “Presentation Content and Key Q&A” from the Chairman’s Press Conference.

Notices Public Relations Committee

We have posted the booklet “Detective Medison and the Six Mysteries (2nd Edition).”

Joint Statement by Three Pharmaceutical Associations from Japan, the U.S., and Europe: Opinions on the FY2025 (Reiwa 7) Interim Drug Price Revision and National Strategy

Regulatory Affairs Committee Event Report

We have posted information on the “14th Annual Conference of the Society for Regulatory Science.”

International Committee Event Report

We have posted the JPMA Media Forum: “Initiatives Regarding Priority Infectious Diseases (Including AMR)—Introduction to Revisions to the Government Action Plan for Countermeasures Against Novel Influenza and Other Diseases, and Future Responses.”

International Committee

We have posted “Proposals from the Pharmaceutical Industry Regarding the Introduction of a Pull-Type Incentive System in the Antimicrobial Market.”

Drug Evaluation Committee

We have posted “eCTD v4.0 Educational Materials, 2nd Edition.”

Drug Evaluation Committee

We have posted the “Guidance on Procedures for the Waiver of Approval Conditions Related to Post-Marketing Surveillance, etc. / Explanation of the ‘Q&A on Post-Marketing Surveillance of Prescription Drugs Using the All-Case Survey Method’ (Ver. 2.0, prepared in October 2024).”

Drug Evaluation Committee

We have posted “Checklist for Transparency in the Sharing of De-identified/Anonymized Data —Based on the Checklist Prepared by TransCelerate—.”

Industry Policy Committee

We have posted the “Survey on Challenges Faced by Healthcare Professionals in the Field of Rare Diseases.”

News Release Industry Policy Committee

Regarding the “Survey on Challenges Faced by Healthcare Professionals in Rare Diseases”

Regulatory Affairs Committee

We have posted the “Report on the Results of the Questionnaire Survey Regarding the Review Status of New Drugs at the Pharmaceuticals and Medical Devices Agency—January 2024 Survey.”

Patient Organization Collaboration Promotion Committee

"Case Studies on PPI (Patient and Public Involvement)" has been posted.

Drug Evaluation Committee

Clinical Trials 119: Updated Q&A “Electronic Records Using a Clinical Trial Cloud System”

Research and Development Committee

“R & D Needs of R & D Committee Member Companies” has been updated.

Drug Evaluation Committee

“Survey Results on the Adoption Status of DCT and Various DCT Methods” has been posted.

Notices Public Relations Committee

A new “Public Affairs Committee” has been added to the Committees page.

News Release Code Compliance Promotion Committee

Notice Regarding the “Code of Practice Understanding Promotion Month” for the JPMA

Notices Pharmaceutical Counseling and Response Review Committee

We have added a new "Consumer Consultation Review Committee" page to the Committee section.

Code Compliance Promotion Committee Event Report

We have posted “FY2024 Meeting of Code Management Officers and Practitioners.”

Notices

We have posted the presentation video from the “October 8 Press Conference by the President of the JPMA.”

Notices

We have posted the “Materials from the JPMA President’s Press Conference Held on October 8.”

Notices Public Relations Committee

We have posted the “FY2024 JPMA PR and Communications Plan.”

Drug Evaluation Committee

Clinical Trials 119: Updated Q&A “Principal Investigator’s Signature on the List of In-House Laboratory Reference Ranges” has been posted.

Patient Organization Collaboration Promotion Committee Event Report

We have released the video recording of the “41st Patient Organization Seminar (Held Online).”

Biopharmaceutical Committee Event Report

We have posted the JPMA Media Forum: “Life Course Immunization in the Era of a 100-Year Life.”

Notices Public Relations Committee

"JPMA Newsletter No. 223" has been published.

Drug Evaluation Committee

"Approaches to QMS Implementation for Clinical Trial Sponsors: Fostering a Culture of Quality and Exercising Leadership" has been posted.

Environmental Issues Review Committee

We have updated the content of the “Carbon Neutrality Action Plan” and the “Voluntary Action Plan for Building a Circular Economy.”

News Release Industry Policy Committee

JPMA 2nd (FY 2024) “Open Call for Proposals Regarding Researcher Support and Grants”

Patient Organization Collaboration Promotion Committee

Information from “Reference: Association for Creating a Society Where Everyone Has Easy Access to Clinical Trials” has been posted.

ICH Project

“The 50th ICH Public Meeting (Held Online)” has been posted.

Research and Development Committee

“R & D Needs of R & D Committee Member Companies” has been updated.

Drug Evaluation Committee

“How to Find Clinical Trials: Understanding jRCT—2nd Edition” has been posted.

Drug Evaluation Committee

"Survey on the Actual Situation Regarding Patients’ and Their Families’ Access to Drug Information – Preliminary Report – (Conducted in February 2024)" has been posted.

ICH Project

We have updated the “49th ICH Public Meeting (Held Online).”

Regulatory Affairs Committee

We have posted “Publication of a Paper Comparing Environmental Impact Assessments of AAV Gene Therapy in Japan and Europe.”

Drug Evaluation Committee

Clinical Trial 119: Q&A Update “Scope of Non-Specialist Members on Institutional Review Boards (Part 6)” has been posted.

Drug Evaluation Committee

"Overview of the FDA CSA Draft Guidance and Considerations on Its Application to the GxP Field" has been posted.

Notices Public Relations Committee

"JPMA Newsletter No. 222" has been published.

Drug Evaluation Committee

"Overview and Key Points of Ethical Guidelines for Life Science and Medical Research Involving Human Subjects" has been posted.

ICH Project

We have updated the “ICH M14 Draft Guideline Workshops.”

News Release

Regarding the “Initiatives to Eliminate Drug Loss” proposed at the Ministry of Health, Labor and Welfare’s Conference on Unapproved Drugs and Off-Label Drugs with High Medical Need

Drug Evaluation Committee

We have posted the “Survey Report to Assess the Current Status of Post-Marketing Database Investigations (Feasibility Studies/Reliability Verification).”

Drug Evaluation Committee

"Prototype Model for Evaluating the Use of AI in Data Management Operations" has been posted.

Notices Code Compliance Promotion Committee

We have updated the “Publicly Disclosed Information for FY2023 Payments” under the “Transparency Guideline for the Relation between Corporate Activities and Medical Institutions, etc.”

Drug Evaluation Committee

"Explanation of the RMP Mark (2024 Revision)" has been posted.

ICH Project

We have posted the “ICH M14 Draft Guideline Workshops.”

Public Relations Committee

The Asahi Shimbun’s “Job Yearbook 2024” has been posted.

Drug Evaluation Committee

"Challenges and Causal Analysis in Health Communication Between Patients/Citizens and Pharmaceutical Companies" has been posted.

Drug Evaluation Committee

"Causal Inference for Interpretation: Causal Mediation Analysis" has been posted.

Drug Evaluation Committee

"To Pharmaceutical Companies Creating Documents for Non-Experts: Communicating Clinical Trial Information in an Easy-to-Understand Manner" has been posted.

Drug Evaluation Committee

"Challenges in Regulatory Documentation for Society 5.0 (Data Society) and Proposals for Utilizing Digital Technology" has been posted.

Drug Evaluation Committee

“Meeting to Discuss the Smooth Implementation of Electronic Data Submission for Regulatory Applications: ‘Survey Results on Consultations Regarding Exemptions from Electronic Data Submission’ and ‘Information Sharing on SDTMIG v3.3 and Define-XML v2.1’” has been posted.

Environmental Issues Review Committee

We have posted “Survey Results on Reducing Environmental Impact Through the Digitization of Package Inserts.”

Drug Evaluation Committee

"Case Studies on the Use of Open-Source Software" has been posted.

Drug Evaluation Committee

"Utilization of Medical Information Databases" has been posted.

Patient Organization Collaboration Promotion Committee

We have updated the information posted by “Reference: Association for Creating a Society Where Everyone Has Easy Access to Clinical Trials.”

Drug Evaluation Committee

"Recommendations on the Collection and Reporting of Safety Data" has been posted.

Drug Evaluation Committee

"Promoting Consistent Quality Management in Clinical Trials: Toward Further Collaboration Between Sponsors and Healthcare Institutions" has been posted.

Drug Evaluation Committee

"Guidelines on Collaborative Clinical Research Using Prescription Drugs and Other Products" has been posted.

Drug Evaluation Committee

“Overview of Medical Device Program (SaMD) Development: An Overview of the Development Process and Development Promotion Systems” has been posted.

Drug Evaluation Committee

We have posted “The Current Status and Potential of Digital Transformation (DX) in Clinical Development.”

Drug Evaluation Committee

“Guidance on ‘Periodic Safety Reports’—Using the Gateway System—(Ver. 2.1, created in April 2024)” has been posted.

Notices Public Relations Committee

We have published the “JPMA Guide 2024.”

Notices Public Relations Committee

"JPMA Newsletter No. 221" has been published.

Drug Evaluation Committee

We have posted information on the symposium “Promoting the Adoption and Optimization of Electrification—Don’t Get Left Behind in the Era of 100% Electrification!”, held online on April 20, 2024.

Drug Evaluation Committee

"Expectations for Policies to Promote the Secondary Use of Real-World Data in Pharmaceutical Development" has been posted.

International Committee

We have posted “Requests Regarding Measures to Promote Research and Development of Drugs for Priority Infectious Diseases (Including AMR).”

ICH Project

"ICH S7B Implementation Working Group: ‘Nonclinical Evaluation of QT/QTc Interval Prolongation and Potential Arrhythmogenicity,’ Mini-Symposium on Participation in the Research Group on In Vivo QT Best Practice Test Methods" has been posted.

Drug Evaluation Committee

"Clinical Pharmacological Evaluation in the Development of New Modalities—Current Status, Challenges, and Future Prospects" has been posted.

ICH Project

“The 49th ICH Public Meeting” has been updated.

Drug Evaluation Committee

We have posted materials from the “Symposium on Pediatric Drug Development” held on March 25, 2024.

Drug Evaluation Committee

Clinical Trial 119: Q&A Update—"Sponsor’s Perspective on Safety Information in Double-Blind Trials" has been updated.

Drug Evaluation Committee

"Current Status and Case Studies of Complex Innovative Trial Designs—Including a Japanese Translation of the FDA Guidance" has been posted.

Drug Evaluation Committee

We have posted the “Report on the Results of the Survey Regarding Patient Participation in Clinical Trials.”

Drug Evaluation Committee

We have posted “Considerations for Simulation in Planning Adaptive Designs.”

News Release APAC Project

Following the “13th Asia Pharmaceutical Association Cooperation Conference”

News Release APAC Project

Press Conference Materials for the 13th Asia Pharmaceutical Association Conference (APAC)

International Committee

We have posted “OHE (Office of Health Economics) Releases New Report Stating That Adult Vaccination Programs Deliver 19 Times the Initial Investment in Socioeconomic Value.”

International Committee

"Global Health Issues" has been updated.

International Committee

“ JPMA Position Statements” has been updated.

Drug Evaluation Committee

We have posted the “E2B(R3) Explanation of Educational Training Materials: April 2024 Revised Edition.”

Drug Evaluation Committee

We have posted “Introduction to Single Sign-On (SSO) for Account Management in Clinical Trial-Related IT Systems.”

Drug Evaluation Committee

"Standard Operating Procedures, etc., Regarding the Electronic Handling of Clinical Trial-Related Documents (2024 Edition)" has been posted.

ICH Project

"ICH E2D (R1) Draft Guideline Workshops" have been posted.

Drug Evaluation Committee

"Common Master Data (Healthcare Facility-Related Information) with a View to Utilizing Clinical Trial-Related Systems" has been posted.

Drug Evaluation Committee

"Guidance on Remote Inspections (Re-examination), Version 3.0 (Prepared in March 2024)" has been posted.

Notices Drug Evaluation Committee

"Glossary of Health and Medical Data" has been posted.

Biopharmaceutical Committee

“Analysis of Application Documents for Approved Regenerative Medicine Products (Life Cycle Management Information)” has been updated.

Notices Research and Development Committee

"R & D Needs of Research Committee Member Companies" has been posted.

Drug Evaluation Committee

"Guidance on Preparing 'Electronic Package Inserts for Prescription Drugs' (Revised April 2024)" has been posted.

Notices

We have published the FY2024 “Business Policy, Business Plan, and Implementation Plan.”

Drug Evaluation Committee

We have posted the “Guidance on Re-examination Applications—Gateway System Usage Edition—(Ver. 2.0, created in March 2024).”

Drug Evaluation Committee

We have posted the “Guidance on Preparing the ‘Post-Marketing Surveillance Implementation Plan’ and ‘Post-Marketing Surveillance Implementation Report’ (2024 Revised Edition).”

Drug Evaluation Committee

Clinical Trial 119: Updated Q&A “Obtaining Consent Regarding the Handling of IRB Members’ Personal Information” and five other items.

International Committee Event Report

“Report on the World NTD Day Event in Japan” has been posted.

Notices Public Relations Committee

"JPMA Newsletter No. 220" has been published.

Patient Organization Collaboration Promotion Committee

“Reference: Association for Creating a Society Where Everyone Has Easy Access to Clinical Trials” has been published.

News Release Public Relations Committee

The second installment of the awareness-raising event in the pharmaceutical and medical fields, “Living with Illness. Living with Hope. Photo Exhibition—Toward a Future That Creates Answers We Have Yet to See,” was held in Osaka.

Regulatory Affairs Committee

We have posted the “Survey Report on the Current Status of Application Lags in Japan.”

Notices

We have published the newspaper advertisement “Let’s Think About Rare Diseases—Toward a Society of Understanding.”

Drug Evaluation Committee

We have posted the materials from Part 2 of the Clinical Evaluation Subcommittee Assembly, “ICH—Clinical Edition: Looking Toward the Future—(Things You’re Too Embarrassed to Ask Now)” (February 16, 2024: Held online).

Notices

“DATA BOOK 2024” has been released.

The Office of Pharmaceutical Industry Research

The Office of Pharmaceutical Industry Research " OPIR Views and Actions No. 71" has been posted on the website.

Drug Evaluation Committee

We have posted “Latest Trends in Regulations and Review of Programmable Medical Devices and Initiatives by the Drug Evaluation Committee” (Held online: February 8, 2024).

Drug Evaluation Committee

We have posted the 4th edition of the Q&A regarding “Registration of Clinical Trial Implementation Status, etc.” (Pharmaceutical and Medical Devices Evaluation and Review Bureau Notice No. 0831-9, August 31, Reiwa 2).

Drug Evaluation Committee

We have posted the “Guidance on Providing Information on ‘Electronic Package Inserts for Prescription Drugs.’”

Industry Policy Committee

We have posted the “FY 2023 Selection Results” for public calls for proposals related to researcher support and grants.

Regulatory Affairs Committee

We have posted the “Report on the Results of a Survey Regarding Companies’ Current Perceptions of Face-to-Face Advisory Services Provided by the Pharmaceuticals and Medical Devices Agency.”

Drug Evaluation Committee

We have posted the “Electronic Detailed Investigation Form for Adverse Event Investigations (JPMA Electronic Model).”

Drug Evaluation Committee

We have posted the educational material “How to Find Clinical Trials: Understanding jRCT.”

Industry Policy Committee Event Report

“Report on the JPMA Rare Disease Day 2024 Symposium” has been posted.

Notices

We have posted the presentation video from the “Press Conference by the President of the JPMA” held on February 15.

News Release

We have posted the “Materials from the JPMA President’s Press Conference Held on February 15.”

Drug Evaluation Committee

We have posted the materials from the symposium “Toward a Proper Understanding and Domestic Implementation of ICH E19” (held online on January 30, 2024).

Drug Evaluation Committee

We have posted information on the lecture held on January 18, 2024, titled “Quality by Design in Clinical Trials and Consistent Quality Management: From the Perspectives of Both Sponsors and Investigator Sites.”

ICH Project

“ Guideline Symposium on ICH E19 “Selective approach to safety data collection in specific late-stage pre-approval or post-approval clinical trials”” has been updated.

Drug Evaluation Committee

We have posted the “Survey Results on Electronic Information Provision—Trends Among JPMA Member Companies (Conducted in January 2023).”

Drug Evaluation Committee

We have posted the “Guidance on Conducting Post-Marketing Database Surveys—January 2024 Edition.”

Drug Evaluation Committee

We have posted the materials from the briefing session on “Guidelines for Providing Information on Clinical Trials to Patients and the General Public, 3rd Edition” (held on December 14, 2023).

Notices Public Relations Committee

“JPMA Newsletter No. 219” has been published.

Public Relations Committee Event Report

“Living with Illness. Living with Hope.” Photo Exhibition: “Media Briefing Held on Opening Day” has been posted.

Public Relations Committee Event Report

“Living with Illness. Living with Hope.” Photo Exhibition: “Media Briefing Held on Opening Day” has been posted.

Notices

Regarding the Reiwa 6 Noto Peninsula Earthquake

Drug Evaluation Committee

We have posted the key points of the “Report on the Current State and Ideal Approach to Database Research in Medical Affairs.”

Notices

We have posted the “2024 New Year’s Greeting from the President of the JPMA.”

Drug Evaluation Committee

We have posted the “Guidelines for Re-examination and Compliance Surveys (Ver. 2.0, created in December 2023).”

Drug Evaluation Committee

"Quality Control—Preventing Fraud" has been posted.

Notices

We have posted a “Newspaper Advertisement.”

ICH Project

We have updated the “48th ICH Public Meeting.”

Public Relations Committee

We have published the report titled “The 17th Survey on Public Perceptions of Medicines and the Pharmaceutical Industry.”

Public Relations Committee

We have published the report titled “The 17th Survey on Public Perceptions of Medicines and the Pharmaceutical Industry.”

News Release Public Relations Committee

About the “17th Public Awareness Survey on Medicines and the Pharmaceutical Industry”

News Release

Joint Statement by Three Pharmaceutical Associations from Japan, the U.S., and Europe: Joint Statement on the FY2024 (Reiwa 6) Drug Pricing System Reform and Cost-Effectiveness Evaluation System Reform

Drug Evaluation Committee

We have posted an introduction to “Collection and Management of Safety Data in Clinical Trials” from Chapter 4 of the CIOMS Working Group VI Report.

Drug Evaluation Committee

We have published a report titled “Quality Control in Drug Development: Examining the Role of Risk Communication,” which reexamines the content of informed consent documents from the perspectives of Clinical Research Coordinators (CRCs) and patients, based on an understanding of what risk communication entails.

Drug Evaluation Committee

We have posted the presentation materials from the 5th Symposium on the Utilization of Medical Information Databases.

Drug Evaluation Committee

We have posted “Challenges and Current Status of Bioequivalence Evaluation for Drugs with Significant Intra-individual Variability.”

Drug Evaluation Committee

We have posted “Survey on Healthcare Professionals’ Needs Regarding Drug Safety Information (Physicians and Pharmacists)—Preliminary Report.”

ICH Project

We have posted the “ICH S1B (R1) Guideline Workshops.”

ICH Project

We have posted the “ICH Q9 (R1) Guideline Workshops.”

ICH Project

"The 5th ICH Forum: ICH Quality Guideline Update" has been posted.

ICH Project

"ICH S12 Guideline Workshops" have been posted.

Environmental Issues Review Committee

“Status of Vision and Goal Setting by Member Companies Toward ‘Carbon Neutrality by 2050’” has been newly posted.

Environmental Issues Review Committee

We have updated the content of the “Carbon Neutrality Action Plan” and the “Voluntary Action Plan for Building a Circular Economy.”

Drug Evaluation Committee

“Drug Development Incorporating Patient Voices”: Symposium for Patients, Citizens, and Pharmaceutical Companies—Video recordings and presentation materials from the event have been posted.

Drug Evaluation Committee

We have posted the presentation materials from the 143rd Assembly of the Drug Evaluation Committee: “Breakthrough to Drug Lag/Loss—Toward the Realization of Safe, Secure, and Well-Being-Oriented Healthcare and Society.”

News Release Public Relations Committee

We have posted the presentation materials from the awareness-raising event in the pharmaceutical and medical fields, “Living with Illness. Living with Hope. Photo Exhibition—Toward a Future That Creates Answers Yet to Be Discovered.”

Drug Evaluation Committee

We have posted “Pharmaceutical Risk Management Plan (RMP): A Comparative Study of Japan, the U.S., and Europe on the Status of Formulating Additional Risk Minimization Activities.”

Regulatory Affairs Committee

We have posted the “Report on the Results of the Questionnaire Survey Regarding the Review Status of New Drugs at the Pharmaceuticals and Medical Devices Agency—January 2023 Survey.”

Notices Public Relations Committee

“JPMA Newsletter No. 218” has been published.

Drug Evaluation Committee

We have updated the “Guidelines for Providing Information on Clinical Trials to Patients and the General Public, 3rd Edition.”

Drug Evaluation Committee

We have updated the “Basic Guidelines on the Handling of Information Provision Related to Clinical Trials.”

Notices Distribution Appropriateness Committee

We have updated the “Industry Standard Manual.”

The Office of Pharmaceutical Industry Research

The Office of Pharmaceutical Industry Research " OPIR Views and Actions, No. 70" has been posted on the website.

International Committee

We have posted the report on the joint symposium titled “Health Challenges Associated with Aging: Dementia and Cancer—Early Initiatives to Extend Healthy Life Expectancy.”

ICH Project

We have updated the “ICH Q9 (R1) Guideline Workshops.”

ICH Project

We have updated the “48th ICH Public Meeting.”

Drug Evaluation Committee

We have posted the “Survey Results on the Provision of Patient Information Using Digital Technologies.”

News Release Code Compliance Promotion Committee

Notice Regarding the “Code of Practice Understanding Promotion Month” for the JPMA

Drug Evaluation Committee

We have posted the presentation materials from “Toward Utilization in Drug Development: Exchange of Views Between Pharmaceutical Companies and Disease Registry Owners.”

Drug Evaluation Committee

We have posted the “List of Registration Items for Trials Migrating from JapicCTI (First Edition)” and the “Comparison Table of jRCT and JapicCTI Registration Items (Second Edition).”

Drug Evaluation Committee

"Survey on the Current State of Model-Informed Drug Development Based on a Survey of Domestically Approved Products" has been posted.

Notices Code Compliance Promotion Committee

The initiative “Consensus Framework for Ethical Collaboration in Japan” received the “2023 The Lighthouse Award.”

Notices Review Board of Ethical Drug Product Information Brochure

We have posted the revised version of the “Guidelines for Preparing Summaries of Product Characteristics for Prescription Drugs.”

Drug Evaluation Committee

We have posted the “Presentation Materials from the Mini-Symposium on Medical Information Databases.”

Notices Public Relations Committee

"JPMA Newsletter No. 217" has been published.

News Release Industry Policy Committee

Regarding the JPMA’s “Open Call for Researcher Support and Grants”

Drug Evaluation Committee

"Data Integration Concept: Proposals from the Front Lines of Healthcare and Clinical Trials" has been posted.

Drug Evaluation Committee

We have updated the “Explanation Materials on Basic Matters for Utilizing eTMF (electronic Trial Master File) and TMF Metrics.”

Notices Distribution Appropriateness Committee

"FAQ Regarding Changes to the EDI Standard Data Format" has been posted.

Notices Distribution Appropriateness Committee

We have updated the “Industry Standard Manual.”

Drug Evaluation Committee

We have published a “Paper on eConsent Practices and Strategies for Resolving Challenges.”

Drug Evaluation Committee

"Points to Note Regarding Regulatory Amendments on the Handling of Safety Information for Investigational Medicinal Products in Clinical Trials" has been posted.

Drug Evaluation Committee

" CTD Structure Using the Results of Multi-Regional Clinical Trials Based on the Principles in ICH E17" has been posted.

ICH Project

We have posted “Guideline Workshops for ICH E6 (R3) ‘Good Clinical Practice’ Guidelines.”

Drug Evaluation Committee

Clinical Trial 119: Q&A Update “Regarding IRB Circulating Review”

Drug Evaluation Committee

Clinical Trial 119: Q&A Update “Scope of ALCOA”

ICH Project

"The 48th ICH Public Meeting" has been posted.

Drug Evaluation Committee

We have posted the “Guidance on Filing Electronic Package Inserts for Prescription Drugs.”

Industry Policy Committee

"Initiatives for Intractable and Rare Diseases" has been updated.

News Release Industry Policy Committee

Regarding the JPMA’s “Proposals on Intractable and Rare Diseases”

International Committee

" 2023" has been posted.

International Committee

We have posted information on the joint symposium titled “Health Challenges Associated with an Aging Population: Dementia and Cancer—Early Initiatives to Extend Healthy Life Expectancy.”

Drug Evaluation Committee

"Ensuring Effective and Efficient Clinical Trial Quality Based on the Quality-by-Design Approach: Aiming for Consistent Quality Management from Planning to Implementation" has been posted.

Notices Public Relations Committee

“JPMA Newsletter No. 216” has been published.

ICH Project

We have updated the “47th ICH Public Meeting.”

ICH Project

"The 47th ICH Public Meeting" has been posted.

Industry Policy Committee

"Disease Awareness, Education, and Information Provision for Patients" has been updated.

Drug Evaluation Committee

We have posted the Q&A for the “Self-Inspection Checklist for Nonclinical Studies_ver.1.”

Drug Evaluation Committee

We have posted the “Presentation Materials for the eCTD v4 Implementation Promotion Briefing” held on Tuesday, June 27, 2023.

The Office of Pharmaceutical Industry Research

The Office of Pharmaceutical Industry Research " OPIR Views and Actions, No. 69" has been posted on our website.

International Committee

We held a seminar on the 2021 AMR Preparedness Index led by GCOA CEO Michel Hodin.

International Committee

We have posted a “Newspaper Advertisement.”

Drug Evaluation Committee

We have posted “Flexible Survival Time Modeling Methods and Methods for Extrapolating Survival Time Using External Information.”

Drug Evaluation Committee

We have posted “Recent Designs of Phase I Cancer Trials and Their Selection.”

Drug Evaluation Committee

We have published “Challenges and Prospects for Efficient Clinical Trials through HL7 FHIR-Based Standardization of Medical Information and Data Integration via Electronic Medical Records (EMR) and Electronic Data Capture (EDC).”

News Release

We published a joint statement by three pharmaceutical industry organizations from Japan, the U.S., and Europe regarding the “Draft Report of the Expert Panel on Comprehensive Measures to Ensure the Rapid and Stable Supply of Pharmaceuticals”

Drug Evaluation Committee

We published “Survey and Analysis of the Current State of Digital Health in Pharmaceutical Companies (Three Deliverables: Digital Health, DTx, and dBM).”

Drug Evaluation Committee

"The Ideal Role and Skill Set for Future Clinical Data Managers—Focusing on Vendor Oversight, QMS, and DCT" has been published.

Notices

We have posted the presentation video from the “Press Conference by the President of the JPMA” held on May 25.

Drug Evaluation Committee

“Utilizing Artificial Intelligence in Data Management: Getting Started with AI” has been published.

Notices Public Relations Committee

We have posted the “JPMA Guide 2023.”

News Release

Notice Regarding the Appointment of New Officers

Drug Evaluation Committee

"Multivariate Meta-Analysis and Alternative Endpoints in Health Technology Assessment" has been published.

Drug Evaluation Committee

"Translation: Data Quality Framework for EU Pharmaceutical Regulations" has been published.

Notices Public Relations Committee

"JPMA Newsletter No. 215" has been published.

Drug Evaluation Committee

"RMP Training Slides for MRs" and "Summary Version: RMP Explanation Slides by MRs (Slide Template for Explaining RMPs to Healthcare Institutions)" have been posted.

Notices

"Newspaper Ads" and "Digital Ads" have been posted.

Drug Evaluation Committee

"The 106th Assembly of the Clinical Evaluation Subcommittee [Part 2]: Clinical Trials in the 'New Normal'—Streamlining and Optimizing Clinical Trials in the Wake of COVID-19" has been posted.

News Release

We have posted “Revision of the Classification of COVID-19 Under the Infectious Diseases Control Law.”

Drug Evaluation Committee

We have posted a Q&A titled “Points to Note Regarding Personal Information Protection in Drug Development and Secondary Use of Data.”

Industry Policy Committee

“Status of Approval and Development of Therapeutics and Vaccines” has been updated.

Drug Evaluation Committee

We have posted “Utilization of Open-Source Software and Points to Note” and the “OSS Usage Survey Report,” prepared by Task Force 5 of the Data Science Subcommittee for FY2022.

News Release Drug Evaluation Committee

We have posted “Announcement Regarding the Release of ‘Health and Medical Data and Our Lives,’ an Awareness Brochure for the General Public on the Use of Health and Medical Data.”

Notices Drug Evaluation Committee

We have published “Health and Medical Data and Our Lives.”

Notices Code Compliance Promotion Committee

We have revised the “JPMA Compliance Program Guidelines.”

Drug Evaluation Committee

We have posted “How to Find Clinical Trials: Understanding jRCT.”

News Release Industry Policy Committee

We have posted “Research and Recommendations on the Pharmaceutical Industry’s Contribution to Extending Healthy Life Expectancy and Driving Economic Growth—Toward the Future of the Pharmaceutical Industry.”

News Release APAC Project

“Following the ‘12th Asia Pharmaceutical Association Cooperation Conference’” has been posted.

News Release APAC Project

We have posted “Press Conference Materials for the 12th Asia Pharmaceutical Association Cooperation Conference (APAC), Held on April 19.”

International Committee

We have posted the report on the survey results for the “2nd Awareness Survey on Promoting the Development of New Antimicrobials to Combat Antimicrobial Resistance.”

News Release

We have posted the joint statement by three pharmaceutical associations from Japan, the U.S., and Europe titled “Proposals for the FY2024 (Reiwa 6) Drug Pricing System Reform.”

Drug Evaluation Committee

Clinical Trials 119: Updated the Q&A section “Trial-Specific Handling of Serious Adverse Events” and three other items.

Patient Organization Collaboration Promotion Committee

We have released the video recording of the “40th Patient Organization Seminar (Held Online).”

Biopharmaceutical Committee

“Analysis of Application Documents for Approved Regenerative Medicine Products (Life Cycle Management Information)” has been updated.

Notices

We have published the “FY 2023 Business Policy, Business Plan, and Implementation Plan.”

Drug Evaluation Committee

We have posted the “Self-Inspection Checklist for Nonclinical Trials, Ver. 1.”

Drug Evaluation Committee

A link to the R&D Head Club website, “Calculation of Clinical Trial Costs Based on Fair Market Value,” has been added under “Toward Achieving Appropriate Clinical Trial Costs in Japan” in the “Related Sites” section.

Industry Policy Committee

"Disease Awareness, Education, and Information Provision for Patients" has been updated.

Drug Evaluation Committee

"Implementation of Estimand in Clinical Trial Protocols" has been posted.

Drug Evaluation Committee

"Points to Consider in Cost-Effectiveness Evaluation: Lessons from Case Studies" has been posted.

Notices Public Relations Committee

"JPMA Newsletter No. 214" has been published.

Drug Evaluation Committee

Electronic Standard for Medical Information Expert Committee We have posted the TF1 deliverable “eCTD v4.0 Educational Materials.”

Notices

We have published “DATA BOOK 2023.”

The Office of Pharmaceutical Industry Research

The Office of Pharmaceutical Industry Research " OPIR Views and Actions No. 68" has been posted on the website.

Drug Evaluation Committee

We have posted “Basic Principles Regarding Clinical Trial Safety Reports.”

Drug Evaluation Committee

We have posted the materials for the FY2022 “Workshop for Practitioners on Electronic Data Submission at the Time of Application.”

International Committee

We have posted the IFPMA’s “Five Priorities for Preparing for and Responding to Future Pandemics.”

Notices

We have posted the “Video of the Presentation from the JPMA Chairman’s Press Conference Held on February 16.”

Drug Evaluation Committee

We have published a discussion on statistical inference for adaptive designs.

Notices

We have posted the “Materials from the JPMA Chairman’s Press Conference Held on February 16.”

News Release

We have posted the “JPMA Policy Proposals 2023.”

Drug Evaluation Committee

We have posted the presentation materials from the symposium “Current Status and Challenges in Estimating Therapeutic Efficacy in the Clinical Development of Rare Diseases” (February 20, 2023), hosted by the Data Science Subcommittee’s FY2022 Continuing Task Force 3.

News Release Industry Policy Committee

Regarding the JPMA “Survey on Challenges Faced by Patients with Rare Diseases”

Notices

We have posted a “Newspaper Advertisement.”

Distribution Appropriateness Committee

We have posted the draft revision (Version 3.5) of the “Industry Standard for the Use of Information Regarding Pharmaceutical Transactions Between Wholesalers and Manufacturers,” scheduled for October 1, 2023.

Notices

We have posted a “Newspaper Advertisement.”

Drug Evaluation Committee

We have posted the materials from the “Briefing Session on Notifications Related to the Revised Act on Pharmaceuticals and Medical Devices and Online Submission of Clinical Trial Notifications,” held on February 6, 2023.

Drug Evaluation Committee

MA KT4: We have posted the “Report on the Current State and Ideal Practices of Database Research in Medical Affairs.”

Quality Committee

We have posted the “Results of the Legal Compliance Survey.”

Drug Evaluation Committee

We have updated the “Survey Results on the Current Status of Clinical Trials at Pharmaceutical Companies.”

Notices Environmental Issues Review Committee

We have established a new “Environmental Issue Committee.”

Industry Policy Committee

“Status of Approval and Development of Therapeutics and Vaccines” has been updated.

Notices Public Relations Committee

"JPMA Newsletter No. 213" has been published.

Drug Evaluation Committee

Clinical Trials 119: Updated Q&A—"Document Explaining Compensation for Adverse Health Effects in Trial Participants"

Drug Evaluation Committee

Clinical Trials 119: Q&A Update—"Web-Based Meetings of the Institutional Review Board"

Drug Evaluation Committee

"Guidelines for Preparing a Pharmaceutical Risk Management Plan (J-RMP) – January Reiwa 5 Edition" has been posted.

Notices

We have posted the “2023 New Year’s Greeting from the President of the JPMA.”

Notices Industry Policy Committee Public Relations Committee

We have posted the PIVOT tie-in video “& questions | What Is Innovation That Will Change Japan?”

Drug Evaluation Committee

"Internal Process Flow for Utilizing Registries in Drug Approval Applications, etc. (From Internal Proposals to Registry Modifications)" has been posted.

Drug Evaluation Committee

“Q&A Regarding the Conduct of Medical Education Meetings and Medical Booths” has been updated.

Drug Evaluation Committee

We have posted the “Guidelines on ‘Medical and Scientific Information Provision’ Conducted by the Medical Affairs Department.”

Drug Evaluation Committee

“Directions for Medical Education Meetings” has been posted.

ICH Project

"The 46th ICH Public Meeting (Held Online)" has been posted.

Drug Evaluation Committee

We have posted the materials from the “Mini-Seminar on Electromagnetic Compatibility” held on December 21, 2022.

News Release

Joint Statement by Three Pharmaceutical Associations from Japan, the U.S., and Europe: Regarding the FY2023 (Reiwa 5) Drug Price Revision

Notices Public Relations Committee

“Textbook: Pharmaceutical Industry 2022–2023” has been published.

Drug Evaluation Committee

We have posted “Methods for Estimating Treatment Efficacy for Rare Diseases.”

Drug Evaluation Committee

We have posted the “Guidelines for Preparing the ‘Post-Marketing Surveillance Implementation Plan’ and ‘Post-Marketing Surveillance Implementation Report’ (2022 Revised Edition).”

Drug Evaluation Committee

"Issues to Be Addressed to Promote the Sharing of Clinical Trial Data" has been posted.

Industry Policy Committee

“Status of Approval and Development of Therapeutics and Vaccines” has been updated.

International Committee

“ Proposals from the Pharmaceutical Industry for the G7 Hiroshima Summit Health Agenda:” has been posted.

News Release Public Relations Committee

About the “16th Survey on Public Perceptions of Medicines and the Pharmaceutical Industry”

Industry Policy Committee

“Status of Approval and Development of Therapeutics and Vaccines” has been updated.

Drug Evaluation Committee

"Introduction to Sequential Multiple Assignment Randomized Trials (SMART)" has been posted.

News Release

We have published the “Joint Opinion on Mid-Year Drug Price Revisions” by three pharmaceutical industry associations from Japan, the U.S., and Europe.

Notices

"Opinion on Access to and Benefit-Sharing of Digital Sequence Information" has been published.

Notices Public Relations Committee

"JPMA Newsletter No. 212" has been published.

News Release

Following the Cabinet’s approval of the “Second Supplementary Budget Bill for Reiwa 4,”

News Release International Committee

Proposals from the Pharmaceutical Industry for the G7 Hiroshima Summit Health Agenda:

Regulatory Affairs Committee

We have posted the “Report on the Results of the Questionnaire Survey Regarding the Review Status of New Drugs at the Pharmaceuticals and Medical Devices Agency—January 2022 Survey.”

Drug Evaluation Committee

"Partial Amendments to the Enforcement Regulations of the Act on Securing the Quality, Efficacy, and Safety of Pharmaceuticals, Medical Devices, and Other Products, and the Enforcement Regulations of the Clinical Research Act　—Points to Note Regarding Post-Marketing Clinical Trials Other Than Those Related to Re-examination and Re-evaluation—" (held on October 27, 2022) have been posted.

Drug Evaluation Committee

Clinical Trial 119: Updated Q&A “Use of Residual Specimens from Clinical Trials for Future Research”

ICH Project

“The 4th ICH Forum: ICH Efficacy Guideline Update” has been posted.

The Office of Pharmaceutical Industry Research

The Office of Pharmaceutical Industry Research " OPIR Views and Actions No. 67" has been posted on the website.

Notices

Following the Cabinet’s approval of the “Comprehensive Economic Measures to Overcome Rising Prices and Achieve Economic Revitalization”—Statement by the President of the JPMA has been posted.

International Committee

We have posted a “Newspaper Advertisement.”

Industry Policy Committee

“Status of Approval and Development of Therapeutics and Vaccines” has been updated.

Industry Policy Committee

We have published “Status of Accumulated Domestic and International Research on Disease Prevention—A Map of Previous Studies” from the Study Group on Extending Healthy Life Expectancy and Driving Economic Growth.

News Release Code Compliance Promotion Committee

We have posted “Notice Regarding the ‘Code of Practice Understanding Promotion Month’ for the JPMA Code of Practice.”

Drug Evaluation Committee

“Considering the Future of Clinical Research in the Face of Transformation (October 2022)” has been posted.

News Release

We have posted an article titled “Collaboration Among the University of Tokyo, Tokyo Medical and Dental University, and the JPMA at the Greater Tokyo Biocommunity (GTB) Hongo, Ochanomizu, and Tokyo Station Area Hub.”

International Committee

We have released a video for Phase 2 of the IFPMA’s “VaccinesForLife” campaign.

Industry Policy Committee

“Status of Approval and Development of Therapeutics and Vaccines” has been updated.

Drug Evaluation Committee

We have published “Current Status and Challenges of DDC/EHR Data Integration.”

Drug Evaluation Committee

We have published “Guidelines for the Electronic Preparation of Adverse Drug Reaction and Infectious Disease Case Reports, etc. – E2B(R3) Compliance – (2022 Edition: Explanation).”

News Release

"Appointment of New Board Members" has been posted.

Notices Public Relations Committee

"JPMA Newsletter No. 211" has been published.

Drug Evaluation Committee

We have published “Causal Inference to Aid in Understanding ICH E9(R1): Time-Dependent Treatment Edition.”

International Committee

We have released a video for Phase 2 of the IFPMA’s “Always Innovation” campaign.

Industry Policy Committee

“Status of Approval and Development of Therapeutics and Vaccines” has been updated.

Notices

We have posted the “Video of the Presentation from the JPMA Chairman’s Press Conference Held on August 30.”

Drug Evaluation Committee

Clinical Trial 119: Q&A Update “Providing Patient Information to the Sponsor Prior to Obtaining Informed Consent”

Drug Evaluation Committee

Clinical Trial 119: Q&A Update “Handling of SAE Reports for Hospitalization Prior to Scheduled Surgery (Part 4)”

Notices

We have posted the “Materials from the JPMA Chairman’s Press Conference Held on August 30.”

Drug Evaluation Committee

We have published “DM Transformation Topic: ‘Data Flow in DCTs and Ensuring Data Reliability.’”

Drug Evaluation Committee

We have published “DM Transformation Topic: ‘Efficient DM Operations Based on Fitness for Purpose.’”

Industry Policy Committee

“Status of Approval and Development of Therapeutics and Vaccines” has been updated.

Biopharmaceutical Committee

“Recommendations on Establishing a Promotion Framework for Vaccines—from Research and Development to Commercialization and Inclusion in Routine Immunization Programs—Based on Basic Strategies for Infectious Disease Prevention (Excluding Matters Related to the Pharmaceutical and Medical Device Act)” has been posted.

Notices Industry Policy Committee

We have posted the presentation materials from the “JPMA Media Forum (held July 19, 2022).”

Drug Evaluation Committee

“ Drug Evaluation From Now On --- What's the value of local data in the global clinical data package?” has been posted.

Drug Evaluation Committee

"Causal Inference to Aid in Understanding ICH E9(R1)" has been posted.

Industry Policy Committee

“Vaccination Status and Adverse Reaction Status” has been updated.

Industry Policy Committee

“Status of Approval and Development of Therapeutics and Vaccines” has been updated.

International Committee

We have posted the “Berlin Declaration” by IFPMA.

Notices Public Relations Committee

"JPMA Newsletter No. 210" has been published.

International Committee

"Signing of the 'Kigali Declaration on Public-Private Partnerships for the Elimination of Neglected Tropical Diseases'" has been posted.

ICH Project

"The 45th ICH Public Meeting (Held Online)" has been updated.

Drug Evaluation Committee

"The Direction MSLs Should Aim For" has been posted.

Drug Evaluation Committee

Clinical Trial 119: Q&A Update—"Attribution of ePRO Data"

Drug Evaluation Committee

Clinical Trial 119: Q&A Update “Form 2: Custodian of the Original List of Investigators and Collaborators”

Industry Policy Committee

“Status of Approval and Development of Therapeutics and Vaccines” has been updated.

Drug Evaluation Committee

"Points to Consider When Using Real-World Data as an External Control in Regulatory Submissions" has been posted.

News Release

Toward Building an Ecosystem to Enhance Japan’s Drug Discovery Capabilities

Notices

An interview with the President of the JPMA, “The Vision We Seek for Japan Now That We Have Experienced COVID-19,” has been posted in the “Magazine” category.

News Release Intellectual Property Committee

Regarding the Agreement on Exemptions from Intellectual Property Protection Obligations (TRIPS Waiver) at the 12th WTO Ministerial Conference

Drug Evaluation Committee

"Considerations for Ensuring the Reliability of Post-Marketing Database Surveys" has been posted.

Industry Policy Committee

“Proper Use of Pharmaceuticals” has been updated.

News Release Industry Policy Committee

Jointly produced and released by the Council for the Proper Use of Medicines and the Japan Pharmaceutical Manufacturers Association: An educational video on polypharmacy titled “How Many Medications Are You Taking?”

News Release

We have posted the “Statement by the R&D-Based Pharmaceutical Industry on the Discussions Scheduled for the 12th WTO Ministerial Conference Regarding Exemptions from Intellectual Property Protection Obligations.”

ICH Project

"Guideline Workshops on the Draft Guidelines 'ICH Q2 (R2): Analytical Method Validation' (Draft) and 'ICH Q14: Analytical Method Development' (Draft), Which Have Reached Step 2" have been posted.

ICH Project

We have posted “Guideline Workshops on the Draft ICH E11A Guideline ‘Extrapolation in the Development of Medicinal Products for Pediatric Use’.”

International Committee

We have posted a Japanese translation of the IFPMA position paper “Applying Lessons Learned from COVID-19 to Create a Healthier, Safer, More Equitable World.”

Notices Public Relations Committee

We have published the “JPMA Guide 2022.”

Notices Patient Organization Collaboration Promotion Committee

We have updated the “About the Transparency Guideline” section of the Guidelines on Transparency in Relationships Between Companies and Patient Organizations.

Industry Policy Committee

“Status of Approval and Development of Therapeutics and Vaccines” has been updated.

Notices Public Relations Committee

"JPMA Newsletter No. 209" has been published.

News Release

We have posted “Proposal by Three Pharmaceutical Associations from Japan, the U.S., and Europe: Joint Proposal for Formulating the ‘Basic Policy’ and ‘Growth Strategy’.”

Notices

We have posted a “Newspaper Advertisement.”

Notices

We have published “Digital Advertising.”

News Release

Discussions at the WTO on Exemptions from Intellectual Property Protection Obligations

International Committee

The website for the AMED Industry-Academia-Government Liaison Committee on Drug Discovery for Infectious Diseases has been launched.

Industry Policy Committee

“Status of Approval and Development of Therapeutics and Vaccines” has been updated.

Drug Evaluation Committee

We have posted information regarding the “Briefing Session on the Registration of Clinical Trial Status and Other Information” held on April 20, 2022.

Drug Evaluation Committee

"Points to Note Regarding the Protection of Personal Information in Drug Development and Secondary Use of Data" has been posted.

Drug Evaluation Committee

We have posted the “Guidelines for Preparing ‘Electronic Package Inserts for Prescription Drugs’—Compliant with the Heisei 29 and Reiwa 3 Guidelines (Reiwa 4 April Edition).”

Drug Evaluation Committee

"Let’s Learn About ‘Medicines’ and ‘Clinical Trials’! (Audio Explanation)" has been posted.

Drug Evaluation Committee

We have posted “Points to Note for Evaluating the Effectiveness of Additional Risk Minimization Activities (Materials) in the Pharmaceutical Risk Management Plan (RMP)—2nd Edition.”

Drug Evaluation Committee

“Form for Communicating Safety Information to Investigator Sites (Recommended by the JPMA)” has been posted.

Drug Evaluation Committee

"Study on Promoting the Utilization of Registries for Pediatric, Rare, and Intractable Diseases" has been posted.

Drug Evaluation Committee

"Tips for Implementing and Utilizing a Quality Management System in Pharmacovigilance" has been posted.

International Committee

“IFPMA ‘Always Innovating’ Campaign” has been posted.

Drug Evaluation Committee

“Data Integrity Regarding Computerized Systems in the GCP Domain (For Management)” has been posted.

Industry Policy Committee

“Status of Approval and Development of Therapeutics and Vaccines” has been updated.

Drug Evaluation Committee

We have posted the “Presentation Materials from the Pediatric Drug Development Workshop” held on March 29, Reiwa 4.

Drug Evaluation Committee

“Utilization and Requirements of Digital Biomarkers (dBM) in Drug Development” has been posted.

International Committee

The AMR Action Fund has announced its first investment.

International Committee

The report titled “The AMR Health Crisis—What We Can Do to Apply Lessons Learned from the COVID-19 Pandemic to Address Antimicrobial Resistance (AMR), the ‘Silent Pandemic’” has been released.

Drug Evaluation Committee

“Clinical Trials 119: Collection of Questions and Opinions” has been updated.

News Release APAC Project

We have posted “Press Conference Materials for the 11th Asia Pharmaceutical Association Conference (APAC), Held on April 6.”

News Release APAC Project

“Reflections on the ‘11th Asia Pharmaceutical Association Cooperation Conference’” has been posted.

Drug Evaluation Committee

"Current Status and Challenges of eConsent in Drug Development" has been posted.

Drug Evaluation Committee

"Survey Results on Remote Inspections (Re-inspections and Compliance Inspections) (March 2022)" has been posted.

Drug Evaluation Committee

We have published “Explanation Materials on Basic Principles for Utilizing eTMF (electronic Trial Master File) and TMF Metrics.”

Drug Evaluation Committee

"Requirements for the Digitization of Paper Originals of Clinical Trial-Related Documents (Focusing on the Handling of Certified Copies)" has been posted.

Notices

We have released the “Business Policy, Business Plan, and Implementation Plan” for fiscal year 2022.

Drug Evaluation Committee

"Characteristics of Digital Certificates Used in the Electronic Data Submission System" has been posted.

Drug Evaluation Committee

We have posted the “Guidebook for Pharmaceutical Companies to Implement Patient-Centric Activities (2022 Edition).”

Drug Evaluation Committee

"Guidance on Remote Inspections (Re-examination)" (January 2022) has been posted.

Biopharmaceutical Committee

“Analysis of Application Documents for Approved Regenerative Medicine Products (Life Cycle Management Information)” has been updated.

Notices

We have posted a “Newspaper Advertisement.”

News Release Drug Evaluation Committee

We have published “Three Organizations Related to Clinical Trials Jointly Formulate a ‘Data Integrity Declaration’.”

Notices Code Compliance Promotion Committee

We have posted the “Transparency Guideline: English Version (Revised January 20, 2022).”

Regulatory Affairs Committee

“Survey on Companies’ Current Perceptions of Face-to-Face Advisory Services Provided by the Pharmaceuticals and Medical Devices Agency” has been posted.

Notices

"DATA BOOK 2022 (English)" has been published.

Notices Public Relations Committee

"JPMA Newsletter No. 208" has been published.

Drug Evaluation Committee

"J-RMP Maintenance as Seen Through Company Case Studies: Proposals for Appropriate Pharmaceutical Risk Management (Reiwa 4 March Edition)" has been posted.

Drug Evaluation Committee

We have posted the presentation materials from the clinical trial awareness briefing held on November 27, 2021, titled “Let’s Learn About ‘Medicines’ and ‘Clinical Trials’!”

Notices Public Relations Committee

We have released “YELL for New Drugs,” a collaboration with Tokyo Graffiti.

Notices Public Relations Committee

We have published videos #5–#8 of “Learning About New Drug Innovation with Pharmacy Student Aoi.”

Drug Evaluation Committee

We have posted materials from the “Briefing on the Revised Act on Pharmaceuticals and Medical Devices—Required Actions for Pharmaceutical Companies Based on Notifications and Case Studies,” held on February 22, 2022.

Drug Evaluation Committee

We have posted the materials from the “Briefing on the Revised Act on Pharmaceuticals and Medical Devices, etc. – Impact on Clinical Trials Due to the Introduction of Investigational Drugs,” held on February 22, 2022.

Drug Evaluation Committee

Clinical Trials 119: Q&A Update “Wash-out Before Obtaining Informed Consent”

Notices

"DATA BOOK 2022 (Japanese)" has been published.

Drug Evaluation Committee

We have posted the presentation materials from “Part 1 of the 10th Data Science (DS) Subcommittee Assembly (Symposium).”

News Release

Joint Statement Released: “Three Priorities for Urgently Expanding Access to COVID-19 Vaccines”

Drug Evaluation Committee

“Current Status and Considerations for Introducing RPA into PV Operations” (February 2022) has been posted.

Industry Policy Committee

“Status of Approval and Development of Therapeutics and Vaccines” has been updated.

Notices

"JPMA Video Content" has been updated.

News Release Public Relations Committee

FY2021 JPMA Communication Plan

Notices Code Compliance Promotion Committee

The “Transparency Guideline (Revised January 20, 2022)” have been posted.

Drug Evaluation Committee

We have posted the pre-event materials for the “Workshop for Practitioners on Electronic Data Submission at the Time of Application.”

Notices Public Relations Committee

We have posted the “Announcement Regarding the Launch of the JPMA’s Official Twitter Account.”

Notices Public Relations Committee

Videos #1–#4 of “Learning About New Drug Innovation with Pharmacy Student Aoi” have been released.

ICH Project

We have posted “Briefing on the Revision and Implementation of the eCTD v4.0 (ICH M8) Notification.”

Industry Policy Committee

“Status of Approval and Development of Therapeutics and Vaccines” has been updated.

Drug Evaluation Committee

We have posted a “Set of Presentation Slides on Methods for Introducing and Utilizing Clinical Trial Methods That Do Not Require In-Person Visits to Medical Institutions.”

Drug Evaluation Committee

We have posted the “GPSP Briefing 2022,” hosted by the PMDA Quality Assurance Department.

Drug Evaluation Committee

“Is Population Adjustment Useful in Indirect Comparisons?—Matching-Adjusted Indirect Comparison and Simulated Treatment Comparison—” has been posted.

Notices

"Materials from the January 20 Press Conference by the Chairman of the JPMA" have been posted.

Notices Public Relations Committee

“JPMA Newsletter No. 207” has been published.

Drug Evaluation Committee

We have posted the “Guidance on Remote Inspections (Re-examination)” (January 2022).

Drug Evaluation Committee

Clinical Trial 119: Q&A Update “Signing the Consent Form on Behalf of the Subject by a Person Equivalent to a Surrogate”

Notices

New Year’s Greetings from the President of the JPMA, 2022

Drug Evaluation Committee

“Toward Achieving Appropriate Clinical Trial Costs in Japan: A Clinical Trial Cost Calculation Process Based on Fair Market Value (Audio Explanation)” has been posted.

Patient Organization Collaboration Promotion Committee

We have released the video recording of the “39th Patient Organization Seminar (Held Online).”

News Release

Reiwa 4 Pharmaceutical Price System Reform

Industry Policy Committee

We have added a new section titled “Information Related to COVID-19.”

ICH Project

We have posted “The 44th ICH Public Meeting (Held Online).”

Drug Evaluation Committee

We have posted the “Guidance on Re-examination and Compliance Investigations” (November 2021).

Notices Public Relations Committee

The Asahi Shimbun’s “Job Yearbook 2021” has been posted.

ICH Project

We have posted the “Guideline Workshops on ICH Q12: ‘Guidance on Technical and Regulatory Considerations for the Life Cycle Management of Medicinal Products.’”

Drug Evaluation Committee

"Introduction to NICE TSD and Model Creation—Evidence Collection and Review for Model Creation" has been posted.

Drug Evaluation Committee

Materials from the “139th Assembly of the Drug Evaluation Committee” have been posted.

International Committee

“The ‘9th Japan-Taiwan Pharmaceutical Exchange Conference’ Was Held” has been posted.

News Release Public Relations Committee

Regarding the “15th Public Awareness Survey on Medicines and the Pharmaceutical Industry”

Notices Public Relations Committee

We have released the “15th Public Awareness Survey on Medicines and the Pharmaceutical Industry.”

Notices Public Relations Committee

"JPMA Newsletter No. 206" has been published.

Drug Evaluation Committee

"Guidance on Applications for Re-examination" has been posted.

Regulatory Affairs Committee

"Report on the Results of the Questionnaire Survey Regarding the Review Status of New Drugs at the Pharmaceuticals and Medical Devices Agency—January 2021 Survey" has been posted.

Drug Evaluation Committee

We have posted the presentation materials from the symposium for pharmaceutical companies titled “Drug Development Incorporating Patient Perspectives.”

News Release Code Compliance Promotion Committee

We have posted “Notice Regarding the ‘Code of Practice Understanding Promotion Month’ for the JPMA Code of Practice.”

Drug Evaluation Committee

"Introduction to NICE TSD and QOL Scores—Measuring QOL Scores and Their Use in Cost-Effectiveness Analysis" has been posted.

Drug Evaluation Committee

Clinical Trial 119: Q&A Update “On the Necessity of IRB Review Regarding Changes to the Clinical Trial Protocol After the Trial’s Completion”

Drug Evaluation Committee

Clinical Trial 119: Q&A Update “IRB Review Regarding the Removal of a Collaborating Investigator”

News Release

A new “List of Non-Financial Information Disclosures” (link collection) for member companies of the JPMA has been added.

Drug Evaluation Committee

Clinical Trial 119: Q&A Update: “Obtaining Informed Consent on or after April 1, 2022”

Drug Evaluation Committee

“Guidance on Periodic Safety Reports” has been posted.

Notices

We have posted a “Newspaper Advertisement.”

Notices ICH Project

Information on the “ICH Quality Forum” has been posted.

Disciplinary Actions Against Member Companies

International Committee

Announcement Regarding “Events Related to the WHO Western Pacific Regional Committee”

Notices Public Relations Committee

"JPMA Newsletter No. 205" has been published.

News Release

Following the Announcement of the “Pharmaceutical Industry Vision 2021”

ICH Project

"Guideline Workshops on the Draft ICH Q13: 'Guideline on Continuous Manufacturing of Drug Substances and Drug Products' (Draft), which has reached Step 2" have been posted.

ICH Project

"ICH S5 and S11 Briefing" has been posted.

News Release

JPMA website has been redesigned.

Drug Evaluation Committee

The “Submission Manual for Electronic Package Inserts for Prescription Drugs” (Reiwa 3 August Edition) has been posted.

Drug Evaluation Committee

"Japanese Translation of the FDA Guidance on Adaptive Design" has been posted.

Notices International Committee Public Relations Committee

We have posted the “JPMA Guide 2021 (English and Chinese Editions).”

International Committee

The Japanese-language website for the AMR Action Fund has been launched.

Notices International Committee

The “IFPMA Vaccines Confidence Digital Campaign” has been updated.

Drug Evaluation Committee

"Three Q&As Received via Clinical Trial 119 on or After July 19, 2021" has been posted.

Drug Evaluation Committee

"Considerations for the Utilization of Clinical Trial Methods Independent of Visits to Medical Institutions—A Guide to Implementation in Japan" has been posted.

ICH Project

“Guideline Workshops on the Draft ICH S12: ‘Nonclinical Biodistribution Considerations for Gene Therapy Products’ (Draft), Which Has Reached Step 2” have been posted.

Drug Evaluation Committee

“Three Q&As Received via Clinical Trial 119 Since March 22, 2021” has been posted.

News Release

Disciplinary Actions Against Member Companies

Drug Evaluation Committee

"Get Started Today! Process Management for Clinical Trials Conducted at Medical Institutions" has been posted.

ICH Project

“Guideline Workshops” has been updated.

ICH Project

"List of Public Meetings" has been updated.

Notices Public Relations Committee

“JPMA Newsletter No. 204” has been published.

Drug Evaluation Committee

We have posted the MA Subcommittee TF3 deliverable “Q&A Regarding the Implementation of Medical Education Sessions and Medical Booths.”

Quality Committee

“Continuous Manufacturing Project Deliverables” have been published.

Drug Evaluation Committee

We have posted “Pharmaceutical Risk Management Plan (RMP): Considerations for Evaluating the Effectiveness of Additional Risk Minimization Activities (Materials).”

Drug Evaluation Committee

"Guidance on Preparing Adverse Event Reports for Combination Products Classified as Drugs (2021 Edition)" has been posted.

Drug Evaluation Committee

We have posted the “Presentation Materials for the Briefing on Amendments to the Act on Pharmaceutical and Medical Devices (Regarding Clinical Trial Notifications and Reports on Adverse Events, etc.)” (held online on June 8, Reiwa 3).

Notices Drug Evaluation Committee

"YouTube Video: Innovative Changes in Data Management" has been posted.

Public Relations Committee

We have posted the event report “JPMA/PhRMA/EFPIA Joint Press Conference.”

Notices Public Relations Committee

"JPMA Guide 2021" has been posted.

Drug Evaluation Committee

“Considerations on Trial Design and Statistical Evaluation Methods in the Development of Regenerative Medicine Products” has been posted.

News Release

“Materials from the JPMA Chairman’s Press Conference Held on May 20” have been posted.

Notices

We have updated the “Chairman’s Message” and “List of Officers.”

Notices

Notice Regarding the Appointment of New Officers

News Release

Regarding the “JPMA Industry Vision 2025: Supplement”

Drug Evaluation Committee

We have posted the “Guidance on Providing Information on Electronic Package Inserts for Prescription Drugs—May 2021 Edition.”

Notices Public Relations Committee

"JPMA Newsletter No. 203" has been published.

News Release

Regarding the Waiver of Intellectual Property Rights at the WTO

Biopharmaceutical Committee

"Analysis of Application Documents for Approved Regenerative Medicine Products (Life Cycle Management Information)" has been posted.

Drug Evaluation Committee

We have posted “Drug Development Utilizing Real-World Data and Disease Registries.”

Drug Evaluation Committee

"Innovative Changes in Data Management (Full Version)" has been posted.

Intellectual Property Committee

"Announcement Regarding IP PACT (IP Principles for Advancing Cures and Therapies)" has been posted.

Notices

We have posted a “Newspaper Advertisement.”

Drug Evaluation Committee

We have posted the “Guidance on Preparing a Pharmaceutical Risk Management Plan (J-RMP) – April Reiwa 3 Edition.”

News Release APAC Project

Following the 10th Asia Pharmaceutical Association Collaboration Conference

Notices

We have released the FY2021 “Business Policy, Business Plan, and Implementation Plan.”

Notices

We have published the “DATA BOOK 2021 (English Edition).”

Notices Public Relations Committee

We have published “Textbook: Pharmaceutical Industry 2020–2021.”

Drug Evaluation Committee

“One Q&A Received via Clinical Trial 119 on or After February 8, 2021” has been posted.

Notices

We have posted materials from the “Press Conference by the Chairman of the JPMA.”

Drug Evaluation Committee

“Symposium on Causal Inference to Aid in Understanding ICH-E9(R1)” (March 2021) has been posted.

Drug Evaluation Committee

"Explanation of Revisions to Notices Regarding Re-examination, Periodic Safety Reports, and Compliance Investigations for Fiscal Year 2020" (March 2021) has been posted.

Notices

We have published “JPMA Policy Proposals 2021.”

Notices

"DATA BOOK 2021 (Japanese)" has been published.

Notices Public Relations Committee

"JPMA Newsletter No. 202" has been published.

International Committee

We have updated the “Global Health Issues” section under Global Health.

International Committee

We have updated the “Universal Health Coverage” section in Global Health.

International Committee

The “Global Health Issues (Infographics)” section of Global Health has been updated.

International Committee

IFPMA has released a campaign video for “#Team Vaccines.”

International Committee

The IFPMA’s “#Team Vaccines” website has been launched.

International Committee

We have published the “IFPMA Vaccines Confidence Digital Campaign.”

Drug Evaluation Committee

We have published “A Study on Methods for Data De-identification Related to CTDS (Clinical Trial Data Sharing).”

Code Compliance Promotion Committee

We have published the “Summary of Results from the Follow-up Survey on the Guidelines for Sales Information Provision Activities (Conducted in November 2020).”

Notices Drug Evaluation Committee

We have published the 5th edition of “Medicines and Clinical Trials.”

Drug Evaluation Committee

We have posted “Two Q&As Received by Clinical Trial 119 on or After December 29, 2020.”

Drug Evaluation Committee

We have posted the “CDISC Resource Collection for Electronic Data Submission (4th Edition) (February 2021).”

Drug Evaluation Committee

We have posted “Notice Regarding the Publication of the ‘Guidance on Creating XML Files for Clinical Trial Notifications (4th Edition)’.”

Drug Evaluation Committee

We have posted the “Workshop for Practitioners on Electronic Data Submission at the Time of Application” Pre-Workshop Materials (February 2021).

News Release Research and Development Committee

"National Center Biobank Network and Japan Pharmaceutical Manufacturers Association Member Companies Launch Industry-Academia-Government Collaboration on the Construction and Utilization of a Disease-Specific Integrated Database—Toward the Early Implementation of Precision Medicine, Prevention, and Proactive Healthcare" has been posted.

Notices Public Relations Committee

"JPMA Newsletter No. 201" has been published.

Drug Evaluation Committee

We have posted three Q&As received via Clinical Trial 119 on or after November 26, 2020.

News Release

“Measures to Combat the Spread of COVID-19—In Response to the Declaration of a State of Emergency”

Industry Policy Committee

“Proper Use of Pharmaceuticals” has been updated.