Updates

Drug Evaluation Committee

A Beginner's Guide to Using NDB in the Pharmaceutical Industry" is now available.

Public Affairs Committee

JPMA Newsletter [Extra]: JPMA Holds First Town Hall Meeting! is now available.

Intellectual Property Committee Event Report

Held "2026 Life Science IP Forum

Review Board of Ethical Drug Product Information Brochure Event Report

Workshop for Persons Responsible for Product Information Overview Management and Practical Responsibility for Product Information Overview Management in 2025" was held.

Drug Evaluation Committee

Results of Questionnaire for Pharmaceutical Companies on Post-Marketing Surveillance" is now available.

Drug Evaluation Committee

The following pages are released / "Names of companies that have adopted the common template for Explanatory and Consent Documents (ICF)" (Japanese only)

Drug Evaluation Committee

Collection of Examples of Cloud System Introduction at Medical Institutions" has been posted on the "Standard Operating Procedures, etc. for Electromagnetic Handling of Clinical Trial Documents (2024 Edition)" page.

Biopharmaceutical Committee

Analysis of Application Materials for Regenerative Medicine Product Approval (Life Cycle Management Information)" is available.

News Release Drug Evaluation Committee

3 organizations have produced and released educational materials for the general public on "Don't believe everything you read" in the medical and health fields.

Drug Evaluation Committee

"Don't "Take Your Belief" in Medical and Health Information!"　Educational materials (jointly by three organizations)" is now available.

Quality & Technology Committee

Q&A on Commercial Production Digital Transformation (DX) Promotion Task Force (TF) Case Studies" is now available.

Drug Evaluation Committee

Handbook of Regulatory Requirements and Issuances for Electronic Information, Sixth Edition" is now available.

Drug Evaluation Committee

The "Contribution of Clinical Pharmacology to Ensuring Diversity in Drug Development" is now available.

Drug Evaluation Committee

The article "CSV Considerations for Client Establishment of a DCT System.

Drug Evaluation Committee

The "Overview of the FDA's "Risk-Based Credibility Assessment of AI Models" Framework" is now available.

Pharmaceutical Industrial Policy Committee

The World of Drugs in the Language of the Next Generation

International Affairs Committee

Creating the Future of Medical Care with Asia: Japan's Contribution to the Collaboration with Bac Mai Hospital (Vietnam)

Public Affairs Committee Event Report

Report on the JPMA Media Forum

Drug Evaluation Committee

Results of Fixed-point Survey on Patient and Public Involvement in Corporate Drug Development" is now available.

Drug Evaluation Committee

Systematic Survey on RWD/RWE - FDA Approval Cases and Approaches to Challenges with Innovative Technologies" is now available.

Drug Evaluation Committee

Survey on the Needs of Healthcare Professionals for Safety Information on Drugs" is now available.

Drug Evaluation Committee

Guidance for Notification of "Electronic Attachment of Ethical Drugs" -April 2026 Edition-" is now available.

Announcement Code Compliance Committee

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

Pharmaceutical Industrial Policy Committee

Open Call for Researchers Support and Grants "FY2025 Adoption Results" is now available.

Announcement

Business Policy, Business Plan, and Implementation Plan" for FY2026 is now available.

Drug Evaluation Committee

Report on the Actual Situation Concerning Publication in MA" is now available.

Drug Evaluation Committee

Toward the Utilization of Structured Data for Clinical Trial Notification" is now available.

Pharmaceutical Industrial Policy Committee Event Report

JPMA Rare Disease Day 2026 Symposium" Report Video and Report are now available.

Drug Evaluation Committee

Checklist for Voluntary Quality Tests_ver.1" is now available.

Drug Evaluation Committee

Presentation Material for Asian eCTD / Gateway System Information Symposium" is now available.

Drug Evaluation Committee

Notes on TMF Data Migration" is now available.

News Release

Election of New Board Members

Drug Evaluation Committee

Q&A on Application for Authorized Users of the Next Generation Medical Infrastructure Act" is now available.

Drug Evaluation Committee

Briefing on Detailed Questionnaire Used for Adverse Reaction Surveillance (JPMA Electronic Model)" is now available.

Distribution Improvement Committee

Updated "FAQs related to changes in the industry standard manual "EDI Uniform Data Format" and JD-NET 8th system renewal.

Environmental Issue Committee

The industry's first Scope 3 guidelines were released at the "Ministry of the Environment Model Project Outcome Debriefing Session.

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

The "Actual Conditions and Challenges of DB Research in MA: A Comprehensive Analysis (FY2025)" is now available.

Patient Cooperation Committee

The following pages are released: "[Interview with a Patient Organization] Small Questions Create the Future: Opening the Door to Participation and Collaboration - Support familia Yamaguchi for Intractable Diseases" (Japanese only).

International Affairs Committee Event Report

Report on "The 5th Japan-Vietnam Joint Symposium" is now available.

Public Affairs Committee Event Report

JPMA Presidents Press Conference" is now available.

Drug Evaluation Committee

The article "Toward the Use of Wearable Devices" is now available.

Drug Evaluation Committee

Proposal for holding the "Workshop on the Implementation of the Clinical Trials Ecosystem Industry Declaration 2025"" is now available.

International Affairs Committee

Pathways from Development to Access to Innovation (IDAP)" is now available.

Drug Evaluation Committee

Information and background necessary for companies to utilize disease registries" is now available.

Announcement

DATA BOOK 2026" is now available.

Drug Evaluation Committee

Survey on Communication Issues at the Time of DCT Introduction" is now available.

Drug Evaluation Committee

2025 Assembly of the Clinical Evaluation Subcommittee, Part 1: Presentation Materials" is posted.

Announcement

JPMA Press Conference on Feb. 19" is now available.

Regulatory Affairs Committee

Report on Results of Questionnaire Survey on Companies' Current Perceptions of Face-to-Face Advice Provided by the Pharmaceuticals and Medical Devices Agency (February 2026)" is posted.

Drug Evaluation Committee

The symposium "Covariate Adjustment for Improving Statistical Efficiency in Randomized Controlled Trials" is now available for viewing in advance.

Drug Evaluation Committee

The "Impact of the "Study Group on Regulation of Pharmaceutical Affairs to Enhance Drug Discovery and Ensure Stable Supplies of Drugs" related notifications as revealed through the results of a survey conducted in the pharmaceutical industry" is now available.

Patient Cooperation Committee

The "Reference: Creating a Society Where Clinical Trials are Accessible to All" has been updated.

Biopharmaceutical Committee Event Report

Report on "CMC Strategy Forum Japan 2025" is now available.

News Release Pharmaceutical Industrial Policy Committee

Proposal on Intractable and Rare Diseases Based on the Survey of Healthcare Professionals' Concerns

Drug Evaluation Committee

The following pages are released: "Hands-on Workshop for Utilization of Medical Information Databases in PV Activities: Video Lecture by Dr. Chieko Ishiguro" (Japanese).

Announcement Public Affairs Committee

JPMA Newsletter No. 228

International Affairs Committee Event Report

The Third Annual Neglected Tropical Diseases Contest is Held

Drug Evaluation Committee

Information on "Symposium on Pediatric Drug Development on March 17, 2026" is now available.

International Affairs Committee

Implementation of the webinar "Toward the Formation of a Global Community to Promote Research and Development of Antimicrobial Agents" was featured on the INCATE website.

Public Affairs Committee Event Report

First Report on the Judging of the Senden Kaigi Award in the Junior High and High School Student Category

Public Affairs Committee Event Report

JPMA and AMED "Joint Press Conference" Report is now available.

Drug Evaluation Committee

JPMA Q&A on the Clinical Research Act and Enforcement Regulations of the Clinical Research Act" is now available.

Drug Evaluation Committee

QMS in PV" is now available.

ICH Project Event Report

Report on "ICH Singapore Meeting" is now available.

Pharmaceutical Industrial Policy Committee Event Report

Report on "The 5th Seminar on Economic Security" is posted.

Drug Evaluation Committee

Mapping of Clinical Trial Documents in TMF Reference Model (Revised Version)" is available.

Announcement

New Year's Greetings

Drug Evaluation Committee Event Report

The 148th Assembly of the Drug Evaluation Committee" is posted.

Drug Evaluation Committee

Asian eCTD / Gateway System Information" was added.

Quality & Technology Committee Event Report

Report on "The 52nd GMP Case Study Workshop in 2025" is now available.

Drug Evaluation Committee

Results of Questionnaire on Information Provision Activities at the Time of Precautionary Statements Revision" is posted.

International Affairs Committee Event Report

Regular meeting with the German Association of the Research-based Pharmaceutical Industry (vfa)" was held

International Affairs Committee Event Report

Special Session at the "12th Nikkei-FT Conference on Infectious Diseases

Drug Evaluation Committee

The following pages are released: "A Review of the First 10 Years since the Introduction of the RMP System from the Pharmaceutical Industry's Perspective" (Japanese only)

Drug Evaluation Committee

Slides for eCTD v4 Implementation Promotion Symposium (JPMA Presentation)" is available.

Drug Evaluation Committee

DX Lecture Slides (19th Annual Assembly of the Japanese Society of Pharmacy)" is available.

Drug Evaluation Committee

Preliminary Study on Application of AI to Quality Management of Clinical Trials" is posted.

R&D Committee

R & D Committee Member Companies' R&D Needs" has been updated.

Drug Evaluation Committee

The following pages are released: "Data Linkage Concept: Data Linkage from the Perspective of Overseas Regulations" (Japanese)

Drug Evaluation Committee

The "Guide to Conducting Post-Marketing Database Surveillance - November 2025 Edition" is now available.

Drug Evaluation Committee

The following pages are released / updated: "Evolution and Deepening of Data Management in Drug Development" (Japanese only)

APAC Project Event Report

Visit to Three Southeast Asian Countries to Host the "15th Asian Pharmaceutical Associations Collaboration Conference (APAC)

Public Affairs Committee Event Report

Report on the 44th Public Relations Seminar

Drug Evaluation Committee

RMP Presentation Slides (27th Annual Meeting of the Japanese Society for Drug Informatics)" is posted.

News Release Drug Evaluation Committee

Issuance of Joint Statement "Clinical Trial Ecosystem Industry Declaration 2025

Biopharmaceutical Committee Event Report

Report on "BioJapan 2025" is now available.

Drug Evaluation Committee

The "Guidance for Conformity Surveillance of Reexamination etc. (Ver. 2.1, October 2025)" is posted.

Regulatory Affairs Committee

"Report on the Results of the Questionnaire Survey on the Review Status of New Pharmaceuticals and New Biologics at the Pharmaceuticals and Medical Devices Agency -January 2025 Survey-" is available.

International Affairs Committee Event Report

Report on Side Events Held during the United Nations Assembly" is posted.

Distribution Improvement Committee

Updated "FAQs related to changes in the industry standard manual "EDI Uniform Data Format" and JD-NET 8th system renewal.

Drug Evaluation Committee

Slide "Survey of RMP Case Studies and Preparation of Case Studies" has been added.

APAC Project Event Report

The 15th APAC (Asia-Pacific Association of Pharmaceutical Manufacturers and Associations) Conference" is now available.

Drug Evaluation Committee

The following pages are released / "Names of companies that have adopted the common template for Explanatory and Consent Documents (ICF)" (Japanese only)

Announcement International Affairs Committee

Information on the webinar "Toward the Formation of a Global Community for the Promotion of Antimicrobial Research and Development" is now available.

Drug Evaluation Committee

The "eCTD v4 Preparation Guide Version 1.0" is now available.

International Affairs Committee

A cover letter template has been created for use in the simplified review system in the Asian region.

News Release Public Affairs Committee

Awarded third place in the "My CareerStudy Course Contest 2025. JPMA's video course for younger college students received high marks from student judges.

Drug Evaluation Committee

Q&A on Quality and Non-clinical Conformity Written Survey" is posted.

Drug Evaluation Committee

The "Impact on Drug Development after the Introduction of ICH M11" is now available.

Announcement Public Affairs Committee

JPMA Newsletter No. 227 is now available.

Announcement

Interviews with Chairpersons" ( Toward Realizing the JPMA's Vision for 2035) is available.

Drug Evaluation Committee

Questionnaire Report on the Promotion of eSource Utilization of Electronic Medical Records, etc." is posted.

Drug Evaluation Committee

RMP Training Slides for MRs (revised August 2025)" is available.

International Affairs Committee Event Report

Report on JPMA Media Forum "Two Major Issues in Countermeasures against Infectious Diseases: Countermeasures against Drug-Resistant Strains of Bacteria and Proper Understanding of Immunization" is now available.

Drug Evaluation Committee

DX Lecture Slides (58th Annual Meeting of the Pharmaceutical Society of Japan)" is now available.

Regulatory Affairs Committee Event Report

The report of "The 15th Annual Meeting of the Regulatory Science Society of Japan" is now available.

Biopharmaceutical Committee Event Report

Dr. Miyabashira, Chairman of the Board, spoke at BioJapan2025 luncheon seminar "Tackling the Challenges of Access to Medicines: Co-creation between the Public and Private Sectors".

News Release Code Compliance Committee

JPMA Code of Practice "Month to Promote Understanding of the JPMA Code

Announcement

Nihon Keizai Shimbun published "My Leadership Essay".

Drug Evaluation Committee

Clinical Trials Ecosystem Industry Declaration 2025 on Quality Challenges" is now available.

Drug Evaluation Committee

The following pages are released / "Names of companies that have adopted the common template for Explanatory and Consent Documents (ICF)" (Japanese only)

Code Compliance Committee Event Report

Report on "FY2025 Meeting of Code Administration Managers and Practitioners" is now available.

Patient Cooperation Committee

The "Reference: Creating a Society Where Clinical Trials are Accessible to All" has been updated.

Drug Evaluation Committee

The article "How to Use Simulation in Bayesian Trial Design" is now available.

Drug Evaluation Committee

The "Survey Report on Drugs Designated under the Pioneer Drug Designation System" is now available.

Drug Evaluation Committee

The "Companies that have already introduced the common template for the Explanatory and Consent Documents (ICF)" is now available.

Announcement Code Compliance Committee

JPMA Code of Practice (Revised May 2025)" Book Issued

The Office of Pharmaceutical Industry Research

The article "Toward the Era of Co-Creation" <17> by Dr. Yamada, Director of the Policy Research Institute, was published in Nikkan Yakugyo.

R&D Committee

The article "Toward the Era of Co-Creation" <16> by Chairperson Tsukahara was published in Nikkan Yakugyo.

Biopharmaceutical Committee Event Report

Report on "JPMA Media Forum" is now available.

ICH Project

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

Drug Evaluation Committee

Scientific Discussion on FDA Review Report" was added.

Announcement R&D Committee

Scientific and Practical Requirements for Drug Candidate Substances Targeted by Companies - Description of Target Product Profile (TPP)" is now available.

International Affairs Committee

The article "Toward the Era of Co-Creation" <15> by Chairperson Murakami of the International Affairs Committee was published.

Intellectual Property Committee

The article by Chairperson Okumura on Nikkan Yakugyo was published in the "Toward the Era of Co-Creation" <14>.

Drug Evaluation Committee

The article by Chairperson Nakaji of the Pharmaceutical Evaluation Committee was published in Nikkan Yakugyo.

Biopharmaceutical Committee

The article by Kurata, Chairperson of Biopharmaceuticals Committee, is published in Nikkan Yakugyo.

Patient Cooperation Committee

The article "Toward the Age of Co-creation" <12> by Chairperson Misawa was published in Nikkan Yakugyo.

Consumer Consultation Review Committee

The article by Chairperson of the Consumer Consultation Review Committee, Mr. Wakasugi, was published in Nikkan Yakugyo.

Review Board of Ethical Drug Product Information Brochure

The article of Nikkan Yakugyo interview with Chairperson of Review Board of Ethical Drug Product Information Brochure, Mr. Kondo, was published in Nikkan Yakugyo.

Quality & Technology Committee

The article by Chairperson Kawashima on Nikkan Yakugyo was published in the "Toward the Era of Co-Creation" <8>.

Public Affairs Committee

Chairperson Tada's article on Nikkan Yakugyo's "Toward the Age of Co-Creation" <9> was published.

International Affairs Committee Event Report

The report on "The 3rd Japan-Malaysia Symposium on Pharmaceutical Regulation" is now available.

News Release Public Affairs Committee

The "3rd Japan-Malaysia Symposium on Drug Regulation" is now available! Hands-on events will be held at the Science Museum. JPMA Kusurium Laboratory 2025 Autumn" where you can learn about drugs in a fun way. SNS campaign for free invitations is also underway!

Code Compliance Committee

The article by Chairperson Ouchi of the Code Compliance Promotion Committee was published in the "Nikkan Yakugyo" section of the "Toward the Age of Co-Creation" <7>.

ICH Project

ICH Project Chairperson Mr. Yokota was interviewed by Nikkan Yakugyo.

Environmental Issue Committee

The article by Chairperson Arima on the Environmental Issues Study Group was published in the "Nikkan Yakugyo" (Daily Yakugyo).

Regulatory Affairs Committee

The article "Toward the Era of Co-Creation" <4> by Chairperson Kashitani was published in Nikkan Yakugyo.

Patient Cooperation Committee

The "Reference: Creating a Society Where Clinical Trials are Accessible to All" has been updated.

Pharmaceutical Industrial Policy Committee Event Report

JPMA members participate in the DIA 2025 Global Annual Meeting and communicate to the world about efforts to address drug lag and loss issues.

Announcement Public Affairs Committee

The "JPMA KYOKAI Kusuriumu Laboratory 2025 Autumn" Invitation Campaign! is now available.

Distribution Improvement Committee

The article by Chairperson Kumagai on the Optimization of Distribution was published in the "Nikkan Yakugyo" (Daily Yakugyo).

Pharmaceutical Industrial Policy Committee

The article, "Toward the Era of Co-Creation <1>," by Chairperson Iwashita of the Industrial Policy Committee, was published.

Announcement Public Affairs Committee

Manga Guide to the Pharmaceutical Industry "Open! The World of Drugs for the Future" is now available.

Announcement

Newspaper Advertisement" is posted.

Drug Evaluation Committee

Information on "Model Credibility Evaluation in Drug Development" is now available.

Drug Evaluation Committee

Tips for Signal Management Activities in Japan" is now available.

Drug Evaluation Committee

Survey Results on Preparation and Sharing of Clinical Trial Results" is available.

News Release Pharmaceutical Industrial Policy Committee

JPMA 3rd (FY 2025) "Open Call for Researcher Support and Subsidy

Announcement Patient Cooperation Committee

Transparency Guideline for the Relationship between Corporate Activities and Patient Groups" has been updated.

Announcement Code Compliance Committee

Transparency Guideline for the Relation between Corporate Activities and Medical Institutions" for the payment of FY2024 has been updated.

Drug Evaluation Committee

Reporting Form for Pharmacovigilance Regulation Survey" is now available.

Drug Evaluation Committee

The following pages are released / updated: "Names of companies that have implemented the Common Template for Explanatory and Consent Documents (ICF)" (Japanese only)

Announcement

JPMA's Vision for 2035" is now available.

Drug Evaluation Committee

DX Presentation Slides (16th Annual Meeting of the Japanese Association of Pharmaceutical Medicine)" is now available.

International Affairs Committee Event Report

Report on "The 6th Japan-Korea Symposium on Pharmaceutical Regulation" is available.

Drug Evaluation Committee

Lecture "Clinical Trial 119" is now available.

News Release Public Affairs Committee

JPMA sponsors the Sendenkaigi Award in the category of junior high and high school students - Creating the future of life together with the young generation who will be responsible for the future.

Drug Evaluation Committee

Workshop "Smooth Electronic Data Submission and Effective Utilization of CDISC-compliant Data": Report on the Results of Questionnaire on "Inquiries on Electronic Data Submission" and "Handling of Deviation Information and Case Acceptance/Rejection"" is now available.

Drug Evaluation Committee

The following pages are released / updated: "Names of companies that have implemented the Common Template for Explanatory and Consent Documents (ICF)" (Japanese only)

Public Affairs Committee

Orientation of the Proposals for the SendenKaigi Award for Junior and Senior High School Students" is now available.

Announcement Public Affairs Committee

JPMA Newsletter No.226" went online.

International Affairs Committee

Research report on the drug-resistant bacteria issue was compiled.

International Affairs Committee

Drug Resistance (AMR) Issues at the Forefront - Two doctors involved in cancer treatment talk about the current situation and challenges -" is now available.

Drug Evaluation Committee

Newly added "Examples of Utilization of RMP/RMP Materials - Mainly for Dispensing Pharmacies" is now available.

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 Issue Committee

Adopted as a "Model Project for Promoting Decarbonization throughout the Entire Value Chain" by the Ministry of the Environment - 12 companies to participate in formulating common rules for calculating CO2 emissions in the pharmaceutical industry

Drug Evaluation Committee

Guidance for Efficient Preparation of Pharmaceutical Documentation (CSR and CTD (Clinical Tables)) in Response to Environmental Changes" is now available.

Pharmaceutical Industrial Policy Committee

JPMA requests the government to strengthen support for unapproved drugs" is now available.

Drug Evaluation Committee

Slide "Current Status and Issues of Post-Marketing Surveillance in Japan - GPSP Questionnaire Survey" (July 5, 2025, 27th Annual Meeting of the Japanese Society for Drug Information)" is posted.

Drug Evaluation Committee

DX Lecture Slides (27th Annual Meeting of the Japanese Society for Drug Information)" is available.

ICH Project

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

Drug Evaluation Committee

The following pages are released / updated: "Drug Use Surveillance for Patients Awareness Leaflet" (Japanese)

Drug Evaluation Committee

RMP Follow-up Survey (1st Interim Results)" is available.

Drug Evaluation Committee

Guidance for Reporting of Drug Failure for Drug Combination Products (2025 Edition)" is updated.

Drug Evaluation Committee

English version of "Non-clinical Checklist and Q&A" is now available.

Drug Evaluation Committee

Evaluation of Validation Necessary to Use Digital Biomarkers as Primary Endpoints in Clinical Trials" is now available.

Drug Evaluation Committee

The following pages are released / updated: "Names of companies that have implemented the Common Template for Explanatory and Consent Documents (ICF)" (Japanese only)

International Affairs Committee Event Report

Meeting with Pharmaceuticals and Medical Devices Agency (PMDA), National Cancer Center (NCC), and National Institute of Health Risk Management (JIHS)" was held to improve the clinical trial environment in Asia.

Drug Evaluation Committee

Covariate Adjustment in Randomized Controlled Trials Based on FDA Guidance" is now available.

International Affairs Committee Event Report

WHA78 Side Event in Geneva "Strengthening Strategic Partnerships to Combat Infectious Diseases (Vector-Borne Diseases, Neglected Tropical Diseases, and Emerging Infectious Diseases)" is now available.

Public Affairs Committee Event Report

Report on "43rd Public Relations Seminar" is available.

ICH Project Event Report

The report of "ICH Madrid Meeting" is available.

ICH Project

The 51st ICH Public Meeting" is now available.

APAC Project Event Report

Report on the 14th APAC (Asian Pharmaceutical Association Conference)

Drug Evaluation Committee

Dawn of the ICH E6(R3) Era: The Future of Clinical Data Manager" is now available.

Drug Evaluation Committee

Information on "Patient Experience Information Useful for Decision-Making in Drug Development" (June 13, 2025) is now available.

Drug Evaluation Committee

Workshop on "R" on April 2, 2025" is now available.

Drug Evaluation Committee Regulatory Affairs Committee Event Report

Report on "FY2025 Joint Assembly of Drug Evaluation Committee and Regulatory Affairs Committee" is now available.

Public Affairs Committee Event Report

JPMA Presidents Press Conference" is now available.

Drug Evaluation Committee

A "Guide for Medical Writers to Prepare Regulatory Documentation in Response to Changes in the Digital Technology Environment, including Generation AI" is now available.

Drug Evaluation Committee

Comparison of Guidance on the Use of RWD/RWE in Japan and the U.S." is now available.

Drug Evaluation Committee

The following pages are released / updated: "Names of companies that have implemented the Common Template for Explanatory and Consent Documents (ICF)" (Japanese only)

Drug Evaluation Committee

Updated "Standard Operating Procedures for Electromagnetic Handling of Clinical Trial Documents (2024 Edition)".

ICH Project

Guideline Workshops on ICH Q1 "Draft Guideline for Stability Testing of Drug Substances and Drug Products" (Step 2 document)" is now available.

Event Report

Dr. Kinoshita participated in a panel organized by "Endpoints News" in the U.S.

Announcement

Video of the presentation "JPMA Press Conference on May 22" is now available.

Drug Evaluation Committee

The "Issues and Priorities Roundtable Report on RWD/RWE Utilization" has been updated.

News Release Code Compliance Committee

JPMA Code of Practice Revision

Drug Evaluation Committee

The "Digital Therapeutics in Japan (DTx): Current Status and Challenges" is now available.

Announcement Public Affairs Committee

JPMA Guide 2025" is now available.

Drug Evaluation Committee

The following pages are released / updated: "Names of companies that have implemented the Common Template for Explanatory and Consent Documents (ICF)" (Japanese only)

Event Report

Managing Director Ishida spoke at an online event for students.

Patient Cooperation Committee

The following pages are released / updated: "Reference: Creating a society where clinical trials are accessible to all.

Announcement

Newspaper and Digital Advertisements" has been updated.

Drug Evaluation Committee

Reference Manual for Clinical Development of Regenerative Medicine Products" is now available.

Announcement Public Affairs Committee

JPMA Newsletter No. 225" is now available.

Drug Evaluation Committee

Q&A on ICF Common Template" is now available.

Drug Evaluation Committee

Handbook on Regulatory Requirements and Issuances of Electronic Information, 5th Edition" is now available.

Announcement

Newspaper and Digital Advertisements" has been updated.

Drug Evaluation Committee

The article "Utilization of Patient Experience Information for Patient-Focused Drug Development - For Decision-Making Based on Patients' Opinions" is now available.

Drug Evaluation Committee

The following pages are released / updated: "Names of companies that have implemented the Common Template for Explanatory and Consent Documents (ICF)" (Japanese only)

Code Compliance Committee Event Report

Report on "FY2024 Workshop for Product Information Overview Managers and Practitioners" is now available.

International Affairs Committee Event Report

Report on "Regular Meeting with Leem (French Association of Pharmaceutical Industries and Associations)" is now available.

News Release APAC Project

Report on the 14th Asian Pharmaceutical Association Conference (APAC) held on April 23.

News Release APAC Project

The 14th Asian Pharmaceutical Association Conference (APAC) Press Conference held on April 23" is now available.

International Affairs Committee

Video content "Messages from seniors to pharmacy students who aspire to become pharmacists" is now available.

Drug Evaluation Committee

The following pages are released / updated: "Names of companies that have implemented the Common Template for Explanatory and Consent Documents (ICF)" (Japanese only)

Drug Evaluation Committee

The video "Model Credibility Assessment in Drug Development" is now available.

Pharmaceutical Industrial Policy Committee Event Report

Report on "JPMA Media Forum" is now available.

Code Compliance Committee Event Report

Report on "FY2024 Meeting of Compliance Managers and Practitioners" is now available.

Drug Evaluation Committee

The following pages are released / updated: "Names of companies that have implemented the Common Template for Explanatory and Consent Documents (ICF)" (Japanese only)

Drug Evaluation Committee

Patient Reported Outcomes in Clinical Trials: A Guide to Using PROs for Clinical Development Professionals" has been re-published.

Public Affairs Committee Event Report

The "Future Drug Researchers are Born! The JPMA's "Kusurium Laboratory," a popular hands-on event, was held.

Pharmaceutical Industrial Policy Committee

Public Call for Researchers Support and Grants "FY2024 Adoption Result" is now available.

Drug Evaluation Committee

Event for medical institutions "Symposium for Promotion of ICF Common Template Utilization: Case Studies of Introduction at Medical Institutions" (Web-based event: Feb. 26, 2025) is now available.

Drug Evaluation Committee

Notice of Revision of the Common Template Document for Explanatory and Consent Documents (ICF)" is now available.

Biopharmaceutical Committee

The report "Analysis of Application Documents for Regenerative Medicine Product Approval (Life Cycle Management Information)" is updated.

Announcement

Business Policy, Business Plan, and Implementation Plan" for FY2025 is now available.

Drug Evaluation Committee

Results of questionnaire for domestic implementation of ICH M11 "Electronically Structured and Harmonized Clinical Study Protocol (CeSHarP)" (FY2024) are now available.

International Affairs Committee

#AlwaysInnovating: Pharmaceutical Industry Facts & Figures is now available.

Intellectual Property Committee Event Report

Report on "2025 Life Science Intellectual Property Forum" is now available.

Drug Evaluation Committee

The "FY2024 Assembly of the Clinical Evaluation Subcommittee Part 2: Presentation Materials" is posted.

ICH Project

ICH M13B "Bioequivalence of Immediate Release Oral Solid Dosage Forms - Additional Content Biowaiver" Guideline Workshops" is posted.

ICH Project

ICH M15 "Draft General Principles for Model-Informed Drug Development" Information Meeting" is now available.

Event Report

JPMA Presidents Press Conference" is now available.

Drug Evaluation Committee

Briefing on "Alliance for Research in Southeast and East Asia (ARISE)" on April 2, 2025.

Drug Evaluation Committee

The "Guide to the Preparation of Periodic Reporting of Infectious Diseases (2025 Revised Edition)" is now available.

Biopharmaceutical Committee Event Report

Report on "CMC Strategy Forum Japan 2024" is now available.

International Affairs Committee Event Report

Report on "Regular Meeting with European Federation of Pharmaceutical Industries and Associations (EFPIA)" is now available.

Drug Evaluation Committee

Presentation materials for "Symposium on eCTD v4 Implementation Promotion" held in November 2024 are now available.

Drug Evaluation Committee

How to proceed with the study of post-marketing database survey using a registry" is now available.

Drug Evaluation Committee

The following pages are released / updated: "Names of companies that have implemented the Common Template for Explanatory and Consent Documents (ICF)" (Japanese only)

Drug Evaluation Committee

The "Asian Trial Network for Adolescent and Translational Oncology Study (ATLAS project) Information Meeting" held on February 25, 2025 is now available.

International Affairs Committee Event Report

The Second Neglected Tropical Diseases Contest" is now available.

Pharmaceutical Industrial Policy Committee

Information on the value of various pharmaceutical products" is now available.

Announcement Code Compliance Committee

Transparency Guideline for the Relation between Corporate Activities and Medical Institutions" is updated.

Announcement

DATA BOOK 2025" is now available.

Announcement

Video presentation of "JPMA Press Conference on February 26th" is now available.

Pharmaceutical Industrial Policy Committee Event Report

JPMA Rare Disease Day 2025 Symposium Report" is now available.

Public Affairs Committee

The 18th Survey on Sei-katsu-sha Attitudes Toward Drugs and the Pharmaceutical Industry" report is now available.

News Release Public Affairs Committee

The "Rare Disease Day 2025 Symposium" report has been uploaded! JPMA to Hold "Kusurium Laboratory," a hands-on event where visitors can learn various knowledge related to pharmaceuticals.

Drug Evaluation Committee

The following pages are released / updated: "Simulation Study for Planning Adaptive Designs" (Japanese only)

Drug Evaluation Committee

The following pages are released / updated: "Points to keep in mind when conducting indirect comparisons in cost-effectiveness evaluations" (Japanese only)

Drug Evaluation Committee

The following pages are released / "Names of companies that have adopted the common template for Explanatory and Consent Documents (ICF)" (Japanese only)

Drug Evaluation Committee

Guide to Viewing PMDA's "Video on Reexamination Compliance Surveillance"" is now available.

Drug Evaluation Committee

Handling of Missing Data in Clinical Trials" has been re-published.

Drug Evaluation Committee

Lecture "QMS and approaches to its implementation at medical institutions and sponsors - Basics and implementation of QMS understood by each individual: Importance of "fostering a culture of quality" and "demonstrating leadership"" on January 23, 2025" is now available.

Announcement Public Affairs Committee

Takisutobukku: Pharmaceutical Industry 2024-2025" is now available.

Drug Evaluation Committee

ICH M10 Guideline Workshops" (Web-based) on April 16, 2025 has been posted.

Drug Evaluation Committee

Guidance for Preparation of Drug Risk Management Plan (J-RMP) -January 2025 Edition- is now available.

R&D Committee

R & D Committee Member Companies' R&D Needs" has been updated.

Announcement Public Affairs Committee

JPMA Newsletter No. 224" is now available.

Drug Evaluation Committee

Leaflet "What is Medical Affairs (MA) for Pharmaceutical Companies?

Announcement Distribution Improvement Committee

Updated "FAQs related to changes in the industry standard manual "EDI Uniform Data Format" and JD-NET 8th system renewal.

News Release Drug Evaluation Committee

Publication of an Educational Video on the Utilization of Health and Medical Data

Drug Evaluation Committee

Newly added: "Real World Data for Cost-Effectiveness Assessment" (Japanese)

Drug Evaluation Committee

Information on "CRC/CRA Joint Workshop in Kansai: Consistent Quality Management Connecting Medical Institutions and Sponsors - Interactive Workshop for CRC and CRA" is now available.

Drug Evaluation Committee

Information on "Workshop for Promoting QMS Implementation - Experiencing Approaches to Organizational Issues" event for pharmaceutical companies/CROs (face-to-face: March 4, 2025) is now available.

APAC Project Event Report

The "Visit to Four Southeast Asian Countries for the 14th APAC (Asian Pharmaceutical Association Conference)" is now available.

Announcement APAC Project

APAC Project" has been newly added to the Committee page.

Drug Evaluation Committee

Report on "OSS Usage Questionnaire Report for FY2024" is now available.

ICH Project Event Report

Report on "ICH Montreal Meeting" is now available.

Drug Evaluation Committee

Information on the event for medical institutions "ICF Common Template Utilization Promotion Symposium: Case Studies in Medical Institutions" (Webinar: 2025/2/26) is now available.

International Affairs Committee Event Report

Report on "Regular Meeting with German Association of Research-based Pharmaceutical Industries (vfa)" is now available.

International Affairs Committee Event Report

Report on the Special Session of "The 11th Nikkei-FT Conference on Infectious Diseases" is now available.

Public Affairs Committee Event Report

Report on "The 42nd Public Relations Seminar" is now available.

Drug Evaluation Committee

Report on "February 5, 2025 Single IRB Workshop" is now available.

Announcement

New Year's Greetings from the JPMA President for the year 2025" is now available.

International Affairs Committee Event Report

The "Regular Meeting with the Association of the British Pharmaceutical Industry (ABPI)" is now available.

Pharmaceutical Industrial Policy Committee Event Report

The report of "The 4th Economic Security Seminar" is now available.

International Affairs Committee Event Report

Report on "The 12th Taiwan-Japan Pharmaceutical Exchange Conference" is now available.

Drug Evaluation Committee

Clinical Trial 119: Q&A update: "Use of data from patients who withdrew their consent for a clinical trial

Biopharmaceutical Committee Event Report

Report on "BioJapan 2024" is now available.

Drug Evaluation Committee

A discussion on pseudonym processing techniques when creating pseudonymized information, etc. is now available.

ICH Project

The 50th ICH Public Meeting (Web-based)" has been updated.

Drug Evaluation Committee

RMP Presentation Slides (34th Annual Meeting of the Japanese Society of Medical Pharmacy)" is available.

International Affairs Committee Event Report

The 7th Japan-India Symposium on Regulation of Medical Products" report is available.

Environmental Issue Committee

The article "Collaboration with Business Partners for Decarbonization" was added.

Drug Evaluation Committee Event Report

Report on "Drug Evaluation Committee Assembly Symposium 2024" is now available.

Patient Cooperation Committee

The following pages are released / updated: "Reference: Creating a society where clinical trials are accessible to all.

Drug Evaluation Committee

English translation of the Director's Notice "Request for Common Forms of Explanatory and Consent Documents for Clinical Trials" (July 4, 2024) and the relevant Notice has been added.

Drug Evaluation Committee

English Translation of the Common Template for Explanatory and Consent Documents (ICF) and the Educational Pamphlet" is now available.

Pharmaceutical Industrial Policy Committee

Whole Genome Analysis and Genomic Medicine Awareness Materials" was posted.

Drug Evaluation Committee

Two "Translation: FDA Guidance on RWD" were posted.

Drug Evaluation Committee

ICH E19 "Selective Approach to Safety Data Collection in Certain Clinical Trials Conducted after Approval or Post-Approval in the Late Phase of Development" is now available.

Announcement

Presentation and Main Questions and Answers" of the Chairman's Press Conference is now available.

Announcement Public Affairs Committee

Booklet "Detective Medizon and the Six Riddles (2nd Edition)" is now available.

Regulatory Affairs Committee Event Report

The 14th Annual Meeting of the Japanese Association for Regulatory Sciences" is now available.

International Affairs Committee Event Report

JPMA Media Forum: "Efforts for Priority Infectious Diseases (including AMR) - Introduction of the Revised Government Action Plan for H1N1 Influenza and Future Responses" is now available.

International Affairs Committee

Proposal from the pharmaceutical industry regarding the introduction of a pull-type incentive system in the antimicrobial agent market" is now available.

Drug Evaluation Committee

eCTD v4.0 Educational Material Version 2" is available.

Drug Evaluation Committee

Explanation of "Procedural Guidance for Lifting Conditions of Approval for Post-Marketing Surveillance" and "Q&A on Investigation of Usage Results of Ethical Drugs by All Patient Surveillance Method" (Ver. 2.0, October 2024)" is available.

Drug Evaluation Committee

Transparency checklist for de-identified/anonymized data sharing - From the checklist prepared by TransCelerate -" is posted.

Pharmaceutical Industrial Policy Committee

Survey on the problems of healthcare professionals in rare diseases" is now available.

News Release Pharmaceutical Industrial Policy Committee

About "Survey on Healthcare Professionals' Concerns in Rare Diseases

Regulatory Affairs Committee

The "Report on the Results of Questionnaire Survey on the Review Status of New Drugs at the Pharmaceuticals and Medical Devices Agency - January 2024 Survey -" is now available.

Patient Cooperation Committee

Case Studies on PPI (Patient and Public Involvement)" is now available.

Drug Evaluation Committee

Clinical Trial 119: Q&A updated "Electromagnetic Records Using the Clinical Trial Cloud System

R&D Committee

R & D Committee Member Companies' R&D Needs" has been updated.

Drug Evaluation Committee

DCT implementation status and results of questionnaire regarding each method of DCT" is now available.

Announcement Public Affairs Committee

Public Affairs Committee" was newly added to the Committee page.

News Release Code Compliance Committee

JPMA Code of Practice "Code Understanding Promotion Month

Announcement Consumer Consultation Review Committee

Consumer Consultation Review Committee" was added to the Committee page.

Code Compliance Committee Event Report

The following pages are released / "FY2024 Meeting of Code Administration Managers and Practice Managers" is posted on the website.

Announcement

Video presentation of "JPMA Press Conference on October 8" is now available.

Announcement Public Affairs Committee

JPMA PR and Communication Plan for FY2024" is now available.

Drug Evaluation Committee

Clinical Trial 119: Q&A update: "Investigator Signatures on the List of In-Hospital Laboratory Reference Values" is posted.

Patient Cooperation Committee Event Report

The 41st Patient Group Seminar (held online) Video Streaming" is now available.

Biopharmaceutical Committee Event Report

JPMA Media Forum "Life Course Immunization in the Era of 100 Years of Life" is now available.

Announcement Public Affairs Committee

JPMA Newsletter No. 223" has been released.

Drug Evaluation Committee

The article "Approaches to QMS Implementation by Clinical Trial Sponsors: Fostering a Culture of Quality and Demonstrating Leadership" is now available.

Environmental Issue Committee

Updated "Carbon Neutral Action Plan" and "Voluntary Action Plan for Establishing a Recycling-Oriented Society".

News Release Pharmaceutical Industrial Policy Committee

JPMA 2nd (FY 2024) "Open Call for Researcher Support and Subsidy

Patient Cooperation Committee

Reference: "Association for Creating a Society Where Clinical Trials are Accessible to All" is now available.

ICH Project

The 50th ICH Public Meeting (Web-based)" is now available.

R&D Committee

R & D Committee Member Companies' R&D Needs" has been updated.

Drug Evaluation Committee

How to Find Clinical Trials - jRCT Mikata - 2nd Edition" is now available.

Drug Evaluation Committee

Preliminary Report on the Survey on Access to Drug Information for Patients and Their Families (conducted in February 2024)" is available.

ICH Project

The "49th ICH Public Meeting" was updated.

Regulatory Affairs Committee

The paper "Comparative Analysis of the Environmental Impact Assessment of AAV Gene Therapy in Japan and Europe" is now available.

Drug Evaluation Committee

Clinical Trial 119: Q&A update: "Scope of Non-Expert Members of Clinical Trial Review Committees (Part 6)" is posted.

Drug Evaluation Committee

FDA CSA Draft Guidance: Overview and Discussion of its Application to the GxP Field" is now available.

Announcement Public Affairs Committee

JPMA Newsletter No. 222" is now available.

Drug Evaluation Committee

Summary and Key Points of the Ethical Guidelines for Life Sciences and Medical Research Involving Human Subjects" is now available.

ICH Project

ICH M14 Guideline Workshops" has been updated.

Drug Evaluation Committee

Questionnaire Report on the Current Status of Post-Marketing DB Surveys (Feasibility Study/Reliability Confirmation)" is now available.

Drug Evaluation Committee

Model Prototype for Investigating the Use of AI in Data Management Operations" is now available.

Announcement Code Compliance Committee

Transparency Guideline for the Relation between Corporate Activities and Medical Institutions" was updated.

Drug Evaluation Committee

Explanation of RMP Mark (Revision 2024)" is now available.

ICH Project

ICH M14 Guideline Workshops" is now available.

Public Affairs Committee

The Asahi Shimbun Company's "Oshigoto Nenkan 2024" has been added.

Drug Evaluation Committee

The "Issues and Causes of Health Communication between Patients/Citizens and Pharmaceutical Companies" is now available.

Drug Evaluation Committee

Causal Inference for Interpretation - Causal Mediation Analysis" is now available.

Drug Evaluation Committee

Pharmaceutical Companies Creating Documents for Non-specialists to Communicate Clinical Trial Information in an Easy-to-Understand Way" is now available.

Drug Evaluation Committee

Proposals for the Application of Digital Technology to Pharmaceutical Documentation for Society 5.0 (Data Society)" is now available.

Drug Evaluation Committee

The following pages are released: "Meeting to Consider Smooth Implementation of Electronic Data Submission: "Results of Questionnaire on Consultation for Exemption from Electronic Data Submission" and "Information Sharing on SDTMIG v3.3 and Define-XML v2.1"".

Environmental Issue Committee

The following pages are released: "Results of Questionnaire Survey on Reduction of Environmental Impact by Digitization of Attached Documents".

Drug Evaluation Committee

Case Studies of Open Source Software Utilization" is now available.

Drug Evaluation Committee

The following pages are released / updated: "Utilization of Medical Information DB" (Japanese)

Patient Cooperation Committee

Updated: "Reference: Society for Creating an Accessible Society for Clinical Trials" (Japanese only)

Drug Evaluation Committee

Proposal on Collection and Reporting of Safety Data" is now available.

Drug Evaluation Committee

The following pages are released: "Promotion of Consistent Quality Management in Clinical Trials: Toward Further Collaboration between Clinical Trial Sponsors and Medical Institutions".

Drug Evaluation Committee

Guideline for Joint Clinical Research Using Ethical Drugs" is now available.

Drug Evaluation Committee

The following pages are released: "Medical Device Program (SaMD) Development Overview: Organizing the Development Process and the Development Promotion System".

Drug Evaluation Committee

The following pages are released / updated: "Current Status and Potential of Digital Transformation (DX) in Clinical Development" (Japanese only)

Drug Evaluation Committee

The "Guide to "Periodic Safety Reporting" - Gateway System Usage Edition (Ver 2.1, April 2024)" is now available.

Announcement Public Affairs Committee

JPMA Guide 2024" is now available.

Announcement Public Affairs Committee

JPMA Newsletter No. 221" is now available.

Drug Evaluation Committee

Symposium "Promotion and Optimization of the Introduction of Electromagnetic Conversion - Don't miss the opportunity in the age of 100% electromagnetic conversion! -" is now available.

Drug Evaluation Committee

Expectations for Policies to Promote Secondary Use of Real World Data in Drug Development" is now available.

International Affairs Committee

Requests for measures to promote research and development of medicines for priority infectious diseases (including AMR)" is now available.

ICH Project

ICH S7B Implementation Working Group: "Non-clinical Evaluation of QT/QTc Interval Prolongation and Potential Proarrhythmic Effects" and Mini-Symposium on Participation in Research Group on In Vivo QT Best Practice Test Methods" is now available.

Drug Evaluation Committee

The following pages are available: "Clinical Pharmacological Evaluation in the Development of New Modalities: Current Status, Challenges, and Future Perspectives.

ICH Project

The "49th ICH Public Meeting" has been updated.

Drug Evaluation Committee

Material for "Symposium on Pediatric Drug Development" on March 25, 2024 is now available.

Drug Evaluation Committee

Clinical Trial 119: Q&A update: "Sponsor's Position on Safety Information in Double-blind Studies" is updated.

Drug Evaluation Committee

Newly added "Current Status of Complex Innovative Trial Design and Case Studies - FDA Guidance with Japanese Translation".

Drug Evaluation Committee

Survey Report on Patient Involvement in Clinical Trials" is now available.

Drug Evaluation Committee

Study of Simulation for Planning Adaptive Design" is now available.

News Release APAC Project

In response to the "13th Asian Pharmaceutical Manufacturers Association Conference

News Release APAC Project

The 13th Asian Pharmaceutical Association Conference (APAC) Press Conference

International Affairs Committee

A new report by the Office of Health Economics (OHE) finds that adult immunization programs provide socioeconomic value 19 times greater than the initial investment" is now available.

International Affairs Committee

Global Health Issues" is updated.

International Affairs Committee

Updated " JPMA Position Statements".

Drug Evaluation Committee

Education and Training Materials for E2B(R3) Explanation Revised April 2024" is now available.

Drug Evaluation Committee

Introduction of Single Sign-On (SSO) to the Current Status of Account Management for Clinical Trial-related IT Systems" is now available.

Drug Evaluation Committee

Standard Operating Procedures for Electromagnetic Handling of Clinical Trial Documents (2024 version)" is now available.

ICH Project

ICH E2D(R1) Guideline Workshops" was added.

Drug Evaluation Committee

"Common Master (Medical Institution Related Information) in anticipation of the Utilization of Clinical Trial Related Systems" was posted.

Drug Evaluation Committee

"Remote Surveillance (Reexamination) Guideline Ver3.0 (March 2024)" is posted.

Announcement Drug Evaluation Committee

Glossary of Health and Medical Data" is now available.

Biopharmaceutical Committee

Analysis of Application Materials for Regenerative Medicine Product Approval (Life Cycle Management Information)" has been updated.

Announcement R&D Committee

R & D Committee Member Companies' R&D Needs" is now available.

Drug Evaluation Committee

Guidance for Preparation of "Electronic Drug Appendix for Prescription Drugs" (Revised April 2024)" is posted.

Announcement

Business Policy, Business Plan, and Implementation Plan" for FY2024 is now available.

Drug Evaluation Committee

Guidance for Application for Reexamination - Gateway System Usage Edition (Ver 2.0, March 2024)" is now available.

Drug Evaluation Committee

Guidance for Preparation of "Postmarketing Surveillance Implementation Plan" and "Postmarketing Surveillance Implementation Report" (Revised 2024)" is now available.

Drug Evaluation Committee

Clinical Trial 119: Q&A updated: "Obtaining Consent for Handling Personal Information of IRB Members" and 5 other items were updated.

International Affairs Committee Event Report

Report on the World NTD Day Japan Event" is now available.

Announcement Public Affairs Committee

JPMA Newsletter No. 220" is now available.

Patient Cooperation Committee

Reference: Creating a society where everyone has easy access to clinical trials" has been released.

News Release Public Affairs Committee

The event "Living with Disease. Living with Hope. Photo Exhibition: "To the Future that Produces Unseen Answers," the second event of the series was held in Osaka.

Regulatory Affairs Committee

Questionnaire Report on the Survey on the Current Status of Application Lag in Japan" is now available.

Announcement

Newspaper advertisement "Let's Think about Rare Diseases - Toward a Society with Understanding" is now available.

Drug Evaluation Committee

The material of "ICH Clinical Evaluation Assembly, Part 2: Clinical Part: Toward the Future" (2024/2/16: Web-based) is now available.

Announcement

DATA BOOK 2024" is now available.

The Office of Pharmaceutical Industry Research

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

Drug Evaluation Committee

The latest trends in regulations and reviews related to programmed medical devices and the Drug Evaluation Committee's activities (Web-based meeting: February 8, 2024)" is now available.

Drug Evaluation Committee

Q&A on "Registration of Clinical Trials (No. 9 of 0831 issued by the Pharmaceutical Affairs Agency on August 31, 2020)" (Japanese only) is now available.

Drug Evaluation Committee

Guidance for Providing Information on "Electronic Drug Appendix of Ethical Drugs" is now available.

Pharmaceutical Industrial Policy Committee

The "FY2023 Adoption Result" of the Open Call for Researcher Support and Subsidies is now available.

Regulatory Affairs Committee

Report on the Results of a Questionnaire Survey on the Current Status of Companies' Perceptions of Face-to-Face Advice Provided by the Pharmaceuticals and Medical Devices Agency" is posted.

Drug Evaluation Committee

Electronic Detailed Questionnaire for Adverse Event Surveillance (JPMA Electronic Model)" is now available.

Drug Evaluation Committee

Educational material "How to Find Clinical Trials - jRCT Mikata" is now available.

Pharmaceutical Industrial Policy Committee Event Report

JPMA Rare Disease Day 2024 Symposium Report" is now available.

Announcement

Video presentation of "JPMA Press Conference on February 15" is now available.

News Release

Presentation Material for JPMA Press Conference on Feb. 15" is available.

Drug Evaluation Committee

The materials for "Symposium on "Appropriate Understanding of ICHE19 and its Introduction in Japan" (Webinar: Jan. 30, 2024)" are now available.

Drug Evaluation Committee

Lecture "Quality by Design and Consistent Quality Management of Clinical Trials - From the Perspective of Both Sponsors and Investigator Sites" on January 18, 2024 is now available.

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

"Results of the Questionnaire on Electronic Provision of Information: Trends of JPMA Participating Companies (conducted in January 2023)" is now available.

Drug Evaluation Committee

Guidance for Conducting Post-Marketing Database Surveys - January 2024 Edition" is now available.

Drug Evaluation Committee

The "Guideline for Providing Information on Clinical Trials for Patients and the General Public, Version 3" Explanatory Meeting (held on December 14, 2023)" materials are now available.

Announcement Public Affairs Committee

JPMA Newsletter No. 219" is now available.

Public Affairs Committee Event Report

Living with Disease. Living with Hope. Photo Exhibition "Media Coverage on the First Day of the Exhibition" is now available.

Announcement

The Noto Peninsula Earthquake of 2024

Drug Evaluation Committee

The main points of "Report on the Actual Situation and State of Database Research in Medical Affairs" are now available.

Announcement

New Year's Greetings from the President of JPMA 2024" is now available.

Drug Evaluation Committee

Guidance for Conformity Surveillance for Reexamination etc. (Ver. 2.0, December 2023)" is now available.

Drug Evaluation Committee

Quality Control - Fraud Detection Prevention" is now available.

Announcement

Newspaper Advertisement" is posted.

ICH Project

The 48th ICH Public Meeting" is updated.

Public Affairs Committee

The report "The 17th Survey on Sei-katsu-sha Attitudes Toward Drugs and the Pharmaceutical Industry" is now available.

Drug Evaluation Committee

Introduction of "Collection and Management of Safety Data in Clinical Trials" from CIOMS Working Group VI Report, Chapter 4 is now available.

Drug Evaluation Committee

The report "Quality Control in Drug Development - Examination of Risk Communication" was published, in which the contents of consent documents were reconsidered from the viewpoints of CRCs and patients, based on what risk communication is.

Drug Evaluation Committee

Presentation materials for the 5th Symposium on Utilization of Medical Information Databases are now available.

Drug Evaluation Committee

The report "Issues and Current Status of Bioequivalence Assessment of Drugs with Large Intra-individual Variation" is now available.

Drug Evaluation Committee

The "Survey on the Needs of Medical Professionals for Safety Information on Drugs (Physicians and Pharmacists) - Preliminary Report -" is now available.

ICH Project

ICH S1B (R1) Guideline Workshops" is available.

ICH Project

ICH Q9 (R1) Guideline Workshops" is now available.

ICH Project

The "5th ICH Forum: ICH Quality Guideline Update" is now available.

ICH Project

ICH S12 Guideline Workshops" is available.

Environmental Issue Committee

Newly added "Member Companies' Status of Vision Setting and Goal Setting for Carbon Neutrality by 2050".

Environmental Issue Committee

Updated "Carbon Neutral Action Plan" and "Voluntary Action Plan for Establishing a Recycling-Oriented Society".

Drug Evaluation Committee

The symposium for patients, citizens, and pharmaceutical companies on "Drug Development Based on Patients' Voices" has been updated.

Drug Evaluation Committee

Presentation materials for the 143rd Assembly of Drug Evaluation Committee "Breakthrough to Drug Lag/Loss: Aiming to Realize Safe, Secure, and Well-Being Medicine and Society" are now available.

News Release Public Affairs Committee

The event "Living with Disease. Living with Hope. Photo Exhibition: "To the Future that Produces Unseen Answers".

Drug Evaluation Committee

Comparative Study on the Status of Formulation of Additional Risk Minimization Activities for Pharmaceutical Risk Management Plans (RMPs) in Japan, the U.S., and Europe) is now available.

Regulatory Affairs Committee

Report on the Results of the Questionnaire Survey on the Review Status of New Drugs at the Pharmaceuticals and Medical Devices Agency - January 2023 Survey -" is now available.

Announcement Public Affairs Committee

JPMA Newsletter No.218" is now available.

Drug Evaluation Committee

Updated "Guidelines for Provision of Information on Clinical Trials for Patients and the General Public (Version 3)".

Drug Evaluation Committee

Basic Policy on the Handling of Information Provision for Clinical Trials" has been updated.

Announcement Distribution Improvement Committee

The "Industry Standard Manual" has been updated.

The Office of Pharmaceutical Industry Research

The Office of Pharmaceutical Industry ResearchOPIR Views and Actions No.70" has been posted on the website of the "Japan Health Insurance Association (JHIA)".

International Affairs Committee

Report on the Joint Symposium "Health Challenges Associated with Aging, Dementia and Cancer: Early Approaches to Extending Healthy Life Expectancy" is now available.

ICH Project

ICH Q9(R1) Guideline Workshops" has been updated.

ICH Project

The 48th ICH Public Meeting" is updated.

Drug Evaluation Committee

Results of Questionnaire on the Use of Digital Technology to Provide Information to Patients" is now available.

News Release Code Compliance Committee

JPMA Code of Practice "Code Understanding Promotion Month

Drug Evaluation Committee

Presentation materials for "Toward Utilization in Drug Development: Opinion Exchange Meeting between Pharmaceutical Companies and Disease Registry Holders" are now available.

Drug Evaluation Committee

List of Registry Items for Studies Transitioning from JapicCTI (Initial Version)" and "jRCT-JapicCTI Registry Items Comparison Chart (Version 2)" are available.

Drug Evaluation Committee

Survey on Model-Informed Drug Development through Investigation of Domestic Approved Drugs" is now available.

Announcement Code Compliance Committee

The activities of "Consensus Framework for Ethical Collaboration in Japan" received "2023 The Lighthouse Award".

Announcement Review Board of Ethical Drug Product Information Brochure

The revised version of "Guidelines for the Preparation of Ethical Drug Product Information Summaries" is posted.

Drug Evaluation Committee

Presentation Material for Mini-Symposium on Medical Information Databases" is now available.

Announcement Public Affairs Committee

JPMA Newsletter No. 217" has been released.

News Release Pharmaceutical Industrial Policy Committee

JPMA "Open Call for Researcher Support and Subsidies

Drug Evaluation Committee

The following pages are released / "Data Linkage Initiative: Proposals from the Field of Medicine and Clinical Trials" is posted.

Drug Evaluation Committee

Explanation of Basic Items for Utilization of eTMF (electronic Trial Master File) and TMF Metrics" was updated.

Announcement Distribution Improvement Committee

FAQ on EDI Uniform Data Format Change" is now available.

Announcement Distribution Improvement Committee

The "Industry Standard Manual" has been updated.

Drug Evaluation Committee

Paper on eConsent Practices and Strategies for Resolving Issues" is now available.

Drug Evaluation Committee

The following pages are released / updated: "Points to keep in mind regarding the revision of regulations on the handling of safety information of investigational new drugs in clinical trials".

Drug Evaluation Committee

CTD Structure Using the Results of Multi-Regional Clinical Trials Based on the Principles in ICH E17 " is now available.

ICH Project

ICH E6(R3) "Guideline Workshops on ICH E6(R3) 'Standards for the Conduct of Clinical Trials of Pharmaceuticals'" is now available.

Drug Evaluation Committee

Clinical Trial 119: Q&A update: "IRB Rotational Discussion

Drug Evaluation Committee

Clinical Trial 119: Q&A update: "Scope of ALCOA

ICH Project

48th ICH Public Meeting" is available.

Drug Evaluation Committee

Guidance for Notification of "Electronic Drug Information Sheet for Prescription Drugs" is available.

Pharmaceutical Industrial Policy Committee

Efforts for Intractable and Rare Diseases" was updated.

News Release Pharmaceutical Industrial Policy Committee

JPMA "Proposal on Intractable and Rare Diseases

International Affairs Committee

2023 " is now available.

International Affairs Committee

Joint Symposium "Health Challenges Associated with Aging, Dementia and Cancer: Early Approaches to Extending Healthy Life Expectancy" is now available.

Drug Evaluation Committee

The new article "Ensuring Effective and Efficient Clinical Trial Quality Based on Quality by Design: Aiming for Consistent Quality Management from Planning to Implementation" is now available.

Announcement Public Affairs Committee

JPMA Newsletter No. 216" has been released.

ICH Project

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

ICH Project

The 47th ICH Public Meeting" is now available.

Pharmaceutical Industrial Policy Committee

Disease Awareness/Education/Information Provision to Patients" is updated.

Drug Evaluation Committee

Q&A "Checklist for Voluntary Inspection of Non-clinical Studies_ver.1" is now available.

Drug Evaluation Committee

The "eCTD v4 Implementation Promotion Briefing Materials" held on Tuesday, June 27, 2023 has been posted.

The Office of Pharmaceutical Industry Research

The Office of Pharmaceutical Industry ResearchOPIR Views and Actions No. 69" on the website of the GCOA.

International Affairs Committee

Seminar on 2021 AMR Preparedness Index by Mr. Michel Hodin, CEO of GCOA.

International Affairs Committee

Newspaper Advertisement" is posted.

Drug Evaluation Committee

Flexible Survival Modeling Methods and Extrapolation of Survival Time Using External Information" is now available.

Drug Evaluation Committee

Recent Cancer Phase I Trial Designs and Selection" is now available.

Drug Evaluation Committee

The following pages are released: "Issues and Prospects for Efficient Clinical Trials through Standardization of Medical Information Based on HL7 FHIR and Data Linkage with Electronic Data Capture (EDC)" (in Japanese).

Drug Evaluation Committee

Current Survey and Discussion on Digital Health in the Pharmaceutical Industry (3 deliverables: Digital Health, DTx, and dBM)" is now available.

Drug Evaluation Committee

The following pages are released: "Ideal Clinical Data Manager Skillset: Vendor Oversight, QMS, and DCT" (Japanese only)

Announcement

Video of the presentation "JPMA Press Conference on May 25th" is now available.

Drug Evaluation Committee

The following pages are released: "Application of Artificial Intelligence in Data Management - Starting with AI -" is now available.

Announcement Public Affairs Committee

JPMA Guide 2023" is now available.

Drug Evaluation Committee

Newly added "Multivariate Meta-analysis and Alternative Endpoints in Medical Technology Assessment

Drug Evaluation Committee

Translation of "Data Quality Framework for EU Medicines Regulation" was added.

Announcement Public Affairs Committee

JPMA Newsletter No. 215" has been released.

Drug Evaluation Committee

RMP Training Slides for MRs" and "Overview Version_RMP Explanation Slides by MRs (Slide Template for RMP Explanation for Medical Institutions)" are available.

Announcement

Newspaper Ads" and "Digital Ads" are now available.

Drug Evaluation Committee

The 106th Assembly of the Clinical Evaluation Committee [Part 2] New Normal Clinical Trial: Optimization and Efficiency of Clinical Trials triggered by COVID-19" was posted.

Drug Evaluation Committee

Q&A on "Points to Consider Regarding the Protection of Personal Information in Drug Development and Secondary Use of Data" is now available.

Pharmaceutical Industrial Policy Committee

Status of Approval and Development of Therapeutic Products and Vaccines" has been updated.

Drug Evaluation Committee

The "Utilization of Open Source Software and Points to Consider" and "OSS Utilization Status Questionnaire Report" prepared by Task Force 5 of the Data Science Subcommittee 2022 are now available.

Announcement Drug Evaluation Committee

The "Health and Medical Data and Our Lives" is now available.

Announcement Code Compliance Committee

JPMA Compliance Program Guidelines" was revised.

Drug Evaluation Committee

How to Find Clinical Trials - jRCT Mikata" is now available.

News Release APAC Project

The following pages are released: "On the Occasion of the 12th Conference of Asian Pharmaceutical Manufacturers and Associations".

News Release APAC Project

The "12th Asian Pharmaceutical Association Conference (APAC) Press Conference on April 19" is now available.

International Affairs Committee

Report on the results of the "2nd Survey on Promotion of Development of New Antimicrobial Agents to Combat Drug Resistance" is now available.

Drug Evaluation Committee

Clinical Trial 119: Q&A updated: "Clinical Trial-Specific Handling of Serious Adverse Events" and 3 other items.

Patient Cooperation Committee

The 40th Patient Group Seminar (Online) Video Streaming" is now available.

Biopharmaceutical Committee

Analysis of Application Materials for Regenerative Medicine Product Approval (Life Cycle Management Information)" has been updated.

Announcement

Business Policy, Business Plan, and Implementation Plan" for FY2023 is now available.

Drug Evaluation Committee

Checklist for Voluntary Inspection of Non-clinical Studies_ver.1" was released.

Drug Evaluation Committee

A link to the R&D Head Club "Calculation of Clinical Trial Costs Based on Fair Market Value" homepage was added to "Toward Realization of Fair Clinical Trial Costs in Japan".

Pharmaceutical Industrial Policy Committee

Disease Awareness/Education/Information Provision to Patients" is updated.

Drug Evaluation Committee

New article "Implementation of Estimand in Clinical Trial Protocols" is now available.

Drug Evaluation Committee

The following pages are released: "Points to keep in mind for cost-effectiveness evaluation based on case studies" (Japanese)

Announcement Public Affairs Committee

JPMA Newsletter No. 214" has been released.

Drug Evaluation Committee

Electronic Standard for Medical Information Expert Committee TF1 deliverable "eCTD v4.0 Educational Material" is now available.

Announcement

DATA BOOK 2023" is now available.

The Office of Pharmaceutical Industry Research

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

Drug Evaluation Committee

Basic Concept of Safety Forms for Clinical Trials" is now available.

Drug Evaluation Committee

Workshop for Practitioners on Electronic Data Submission at the Time of Application" materials for FY2022 have been posted.

International Affairs Committee

IFPMA's "Five Priorities for Preparing for and Responding to Future Pandemics" is now available.

Announcement

Video of the Feb. 16 JPMA Presidents' Press Conference Presentation" is now available.

Drug Evaluation Committee

Statistical Inference for Adaptive Design" is now available.

Drug Evaluation Committee

Presentation materials for the symposium on "Current Status and Issues of Inference of Therapeutic Effects in Clinical Development of Rare Diseases" organized by the Data Science Subcommittee FY2022 Continuing Task Force 3 (February 20, 2023) have been posted.

News Release Pharmaceutical Industrial Policy Committee

JPMA "Survey on the problems of patients with rare diseases

Announcement

Newspaper Advertisement" is posted.

Distribution Improvement Committee

The "Industry Standard for the Use of Information on Commercial Pharmaceutical Transactions between Wholesalers and Manufacturers" (Version 3.5), to be revised as of October 1, 2023, is now available.

Announcement

Newspaper Advertisement" is posted.

Drug Evaluation Committee

Presentation materials for "Explanatory Meeting on Notification related to Revised Pharmaceuticals and Medical Devices Act and Online Submission of Clinical Trial Notification" held on February 6, 2023 are now available.

Drug Evaluation Committee

MA KT4: "Report on the Actual Situation and State of Database Research in Medical Affairs" is posted.

Quality & Technology Committee

Results of Legal Compliance Questionnaire" is posted.

Drug Evaluation Committee

Results of Questionnaire Survey on Current Status of Clinical Trials for Pharmaceutical Companies" has been updated.

Announcement Environmental Issue Committee

Environmental Issue Committee" is newly established.

Pharmaceutical Industrial Policy Committee

Status of Approval and Development of Therapeutic Products and Vaccines" has been updated.

Announcement Public Affairs Committee

JPMA Newsletter No. 213" has been released.

Drug Evaluation Committee

Clinical Trial 119: Q&A update: "Documents explaining compensation for health damage to subjects

Drug Evaluation Committee

Clinical Trial 119: Q&A update: "Web-based Convening of Clinical Trial Review Committee

Drug Evaluation Committee

Guidance for Preparation of Drug Risk Management Plan (J-RMP) -January 2023 Edition-" is now available.

Announcement Pharmaceutical Industrial Policy Committee Public Affairs Committee

PIVOT Tie-in Video "& questions｜What kind of innovation will change Japan? is now available.

Drug Evaluation Committee

The following pages are released: "Internal Process Flow for Utilization of the Registry for Drug Applications (From Internal Proposal to Registry Modification).

Drug Evaluation Committee

Q&A on Medical Education Meetings and Medical Booths" was updated.

Drug Evaluation Committee

Guidance for Medical Affairs Department in Providing Medical and Scientific Information" is now available.

Drug Evaluation Committee

The "Direction of the Medical Education Meeting" is now available.

ICH Project

The 46th ICH Public Meeting (Web-based)" is available.

Drug Evaluation Committee

The material of "Mini-Seminar on Electromagnetic Compliance" on December 21, 2022 has been added.

Announcement Public Affairs Committee

"Drug Industry 2022-2023" (in Japanese) is now available.

Drug Evaluation Committee

Newly added "Estimation of Therapeutic Effects of Rare Diseases" is now available.

Drug Evaluation Committee

Guidance for Preparation of "Post-marketing Surveillance Implementation Plan" and "Post-marketing Surveillance Implementation Report" (revised edition of 2022)" is now available.

Drug Evaluation Committee

Issues to be resolved to promote the sharing of clinical trial data" is posted.

Pharmaceutical Industrial Policy Committee

Status of Approval and Development of Therapeutic Products and Vaccines" has been updated.

International Affairs Committee

Proposals from the Pharmaceutical Industry for the G7 Hiroshima Summit Health Agenda: " is now available.

News Release Public Affairs Committee

The 16th Annual Survey on Sei-katsu-sha Attitudes Toward Drugs and the Pharmaceutical Industry

Pharmaceutical Industrial Policy Committee

Status of Approval and Development of Therapeutic Products and Vaccines" has been updated.

Drug Evaluation Committee

Introduction of Sequential Multiple Assignment Randomized Trials (SMART)" is now available.

Announcement

Opinion on Access to Digital Sequence Information and Benefit-Sharing" is now available.

Announcement Public Affairs Committee

JPMA Newsletter No. 212" is now available.

Regulatory Affairs Committee

Report on the Results of the Questionnaire Survey on the Review Status of New Drugs at the Pharmaceuticals and Medical Devices Agency - January 2022 Survey -" is now available.

Drug Evaluation Committee

Video presentation on "Partial Amendment of Enforcement Regulations of the Act on Quality, Efficacy and Safety Assurance of Pharmaceuticals and Medical Devices and Enforcement Regulations of the Clinical Research Act - Points to keep in mind regarding post-marketing clinical trials other than post-marketing clinical trials for re-examination and re-evaluation -" (October 27, 2022) is available. Video clips and documents of the meeting (held on October 27, 2022) are now available.

Drug Evaluation Committee

Clinical Trial 119: Q&A update: "Use of Residual Specimens from Clinical Trials for Future Research

ICH Project

The 4th ICH Forum: ICH Efficacy Guideline Update" is now available.

The Office of Pharmaceutical Industry Research

The Office of Pharmaceutical Industry ResearchOPIR Views and Actions No.67" was posted on the website of

Announcement

Statement by JPMA Chairman on the Cabinet Decision on "Comprehensive Economic Measures to Overcome High Prices and Revitalize the Economy" is now available.

International Affairs Committee

Newspaper Advertisement" is posted.

Pharmaceutical Industrial Policy Committee

Status of Approval and Development of Therapeutic Products and Vaccines" has been updated.

Pharmaceutical Industrial Policy Committee

Study Group on Extending Healthy Life Expectancy and Driving Economic Growth "Accumulation of Domestic and Foreign Research on Disease Prevention - Map of Prior Studies" is now available.

News Release Code Compliance Committee

JPMA Code of Practice "Month to Promote Understanding of the JPMA Code of Practice"" is now available.

Drug Evaluation Committee

The "Future of Clinical Research in a Changing World (October 2022)" is now available.

International Affairs Committee

IFPMA's VaccinesForLife Campaign Phase2 video is now available.

Pharmaceutical Industrial Policy Committee

Status of Approval and Development of Therapeutic Products and Vaccines" has been updated.

Drug Evaluation Committee

The following pages are released: "Current Status and Challenges of DDC/EHR Data Linkage" (Japanese)

Drug Evaluation Committee

Explanation of the "Guidance for Electronic Reporting of Adverse Reactions and Infectious Drug Reactions - E2B(R3) Compliance - (2022 Edition)" is now available.

Announcement Public Affairs Committee

JPMA Newsletter No. 211" is now available.

Drug Evaluation Committee

Causal Reasoning for Understanding ICH E9(R1) - Time-Dependent Treatment" is now available.

International Affairs Committee

Video of Phase 2 of the AlwaysInnovation Campaign by IFPMA is now available.

Pharmaceutical Industrial Policy Committee

Status of Approval and Development of Therapeutic Products and Vaccines" has been updated.

Announcement

Video of "JPMA Presidents Press Conference Presentation on August 30" is now available.

Drug Evaluation Committee

Clinical Trial 119: Q&A update: "Providing Patient Information to the Sponsor Prior to Obtaining Consent

Drug Evaluation Committee

Clinical Trial 119: Q&A update: "Handling of SAE Reporting for Admission for Scheduled Surgery (Part 4)

Drug Evaluation Committee

Revised topic "Data Flow in DCT and Ensuring Reliability" is now available.

Drug Evaluation Committee

The following pages are released / Topics for DM innovation: "Efficient DM operations based on Fitness for Purpose" (Japanese only)

Pharmaceutical Industrial Policy Committee

Status of Approval and Development of Therapeutic Products and Vaccines" has been updated.

Biopharmaceutical Committee

Proposal for the development of a promotion system for vaccines from research and development to practical application and routine vaccination based on the basic strategy for the prevention of infectious diseases (excluding those related to the Pharmaceuticals and Medical Devices Law)" is now available.

Announcement Pharmaceutical Industrial Policy Committee

Presentation materials for "JPMA Media Forum (July 19, 2022)" are now available.

Drug Evaluation Committee

Drug Evaluation From Now On --- What's the value of local data in the global clinical data package? " is now available.

Drug Evaluation Committee

Causal Inference for Understanding ICH E9(R1)" is posted.

Pharmaceutical Industrial Policy Committee

Status of Vaccination and Adverse Reactions" is updated.

Pharmaceutical Industrial Policy Committee

Status of Approval and Development of Therapeutic Products and Vaccines" has been updated.

International Affairs Committee

Berlin Declaration" by IFPMA is now available.

Announcement Public Affairs Committee

JPMA Newsletter No. 210" is now available.

International Affairs Committee

The Kigali Declaration, a public-private partnership for the control of neglected tropical diseases, has been signed.

ICH Project

The 45th ICH Public Meeting (Web-based)" was updated.

Drug Evaluation Committee

The following pages are released / updated: "The Direction of MSL" (Japanese only)

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

Pharmaceutical Industrial Policy Committee

Status of Approval and Development of Therapeutic Products and Vaccines" has been updated.

Drug Evaluation Committee

The following pages are released: "Points to keep in mind when using Real World Data as an external control in regulatory filings" (Japanese only)

Announcement

JPMA President's Dialogue: "The Vision for Japan after the New Corona" has been added in the "Journal" category.

News Release Intellectual Property Committee

TRIPS Weber Agreement at the 12th WTO Ministerial Conference

Drug Evaluation Committee

"Examination of Issues for Ensuring Confidence in Post-Marketing Database Surveillance" is now available.

Pharmaceutical Industrial Policy Committee

The following pages are released / updated: "Proper Use of Medicines" (Japanese only)

News Release Pharmaceutical Industrial Policy Committee

The 12th WTO Ministerial Conference on the Proper Use of Drugs and the Japan Pharmaceutical Manufacturers Association (JPMIA) jointly produced and released an educational video on polypharmacy, "How Many of Your Drugs Are You Taking?

News Release

The "Statement by the R&D-Based Pharmaceutical Industry on the Consultation on the Exemption from Intellectual Property Protection Obligations Scheduled for the 12th WTO Ministerial Conference" is now available.

ICH Project

ICH Q2(R2) / Q14: Guideline Workshops on the Draft Guideline "ICH Q2(R2): Analytical Method Validation" and "ICH Q14: Analytical Method Development" reached Step 2" are now available.

ICH Project

ICH E11A: Extrapolation in Pediatric Drug Development" Guideline Workshops" is now available.

International Affairs Committee

Japanese translation of IFPMA proposal "Applying Lessons Learned from COVID-19 to Create a Healthier, Safer, More Equitable World" is available.

Announcement Public Affairs Committee

JPMA Guide 2022" is now available.

Announcement Patient Cooperation Committee

Transparency Guideline" of "Transparency Guideline on the Relationship between Corporate Activities and Patient Groups" is updated.

Pharmaceutical Industrial Policy Committee

Status of Approval and Development of Therapeutic Products and Vaccines" has been updated.

Announcement Public Affairs Committee

JPMA Newsletter No. 209" is now available.

News Release

Proposal by Japan, the U.S., and Europe: Joint Proposal for the Formulation of a "Framework Policy" and a "Growth Strategy"" is now available.

Announcement

Newspaper Advertisement" is posted.

Announcement

Newly added "Digital Advertising" is now available.

International Affairs Committee

AMED Infectious Disease Drug Discovery Industry-Academia-Government Liaison Committee website is now available.

Pharmaceutical Industrial Policy Committee

Status of Approval and Development of Therapeutic Products and Vaccines" has been updated.

Drug Evaluation Committee

Briefing Session on Registration of Clinical Trials" on April 20, 2022 has been posted.

Drug Evaluation Committee

The following pages are released: "Points to Keep in Mind Concerning the Protection of Personal Information in Drug Development and Secondary Use of Data".

Drug Evaluation Committee

Guidance for Preparation of Electronic Attached Documents of Ethical Drugs -Corresponding to the Guidelines for Description in 2009 and 2021 - (April 2022 edition)" is posted.

Drug Evaluation Committee

The following pages are released: "Let's learn about 'Pharmaceuticals' and 'Clinical Trials' (audio description)! (Audio description)" is posted.

Drug Evaluation Committee

The "Pharmaceutical Risk Management Plan (RMP): Considerations for Evaluating the Effectiveness of Additional Risk Minimization Activities (Materials) (Version 2)" is now available.

Drug Evaluation Committee

JPMA Recommended Form for Communicating Safety Information to Investigator Sites" is now available.

Drug Evaluation Committee

Study to Promote the Utilization of the Registry for Pediatric, Rare and Intractable Diseases" is now available.

Drug Evaluation Committee

Tips for introducing and utilizing Quality Management System in PV" is now available.

International Affairs Committee

IFPMA AlwaysInnovating Campaign" is now available.

Drug Evaluation Committee

Data Integrity Regarding Computerized Systems in the GCP Area (for Management)" is now available.

Pharmaceutical Industrial Policy Committee

Status of Approval and Development of Therapeutic Products and Vaccines" has been updated.

Drug Evaluation Committee

Presentation Material for Pediatric Drug Development Workshop held on March 29, 2022" is now available.

Drug Evaluation Committee

The following pages are released: "Utilization and Requirements for Digital Biomarkers (dBM) in Drug Development" (Japanese only).

International Affairs Committee

AMR Action Fund announced its first investment project.

International Affairs Committee

The report "The Health Crisis of AMR: What We Can Do to Learn from Novel Coronavirus Infections to Counter the Silent Pandemic of Drug Resistance (AMR)" is now available.

Drug Evaluation Committee

Clinical Trial 119: Questions and Opinions" has been updated.

News Release APAC Project

The "11th Asian Pharmaceutical Association Conference (APAC) Press Conference on April 6" is now available.

News Release APAC Project

The following pages are released: "The 11th Asian Pharmaceutical Association Conference (APAC) Press Conference" is now available.

Drug Evaluation Committee

The following pages are released / updated: "Current Status and Issues of eConsent in Drug Development" is posted.

Drug Evaluation Committee

The following pages are released: "Results of Questionnaire Survey on Remote Surveillance (Reexamination Compliance Surveillance) (March 2022)" is posted.

Drug Evaluation Committee

Explanation of Basic Items for Utilization of eTMF (electronic Trial Master File) and TMF Metrics" is posted.

Drug Evaluation Committee

What is required to digitize paper originals of clinical trial-related documents (focusing on the operation of Certified Copy)" is posted.

Announcement

Business Policy, Business Plan, and Implementation Plan" for FY2022 is now available.

Drug Evaluation Committee

Characteristics of Electronic Certificates Used in the Application Electronic Data System" is now available.

Drug Evaluation Committee

Guidebook for Pharmaceutical Companies to Implement Patient Centricity-based Activities (2022 Edition)" is now available.

Drug Evaluation Committee

Guidebook for Remote Investigation (Reexamination)" (January 2022) is now available.

Biopharmaceutical Committee

Analysis of Application Materials for Regenerative Medicine Product Approval (Life Cycle Management Information)" has been updated.

Announcement

Newspaper Advertisement" is posted.

News Release Drug Evaluation Committee

Newly added "Three Organizations for Clinical Trials and Clinical Trials Jointly Formulate 'Data Integrity Declaration'".

Announcement Code Compliance Committee

Transparency Guideline English version (revised on January 20, 2022)" is now available.

Regulatory Affairs Committee

Questionnaire Survey on Companies' Perception of Face-to-Face Advice Provided by the Pharmaceuticals and Medical Devices Agency" is posted.

Announcement

DATA BOOK 2022" is now available.

Announcement Public Affairs Committee

JPMA Newsletter No.208" is now available.

Drug Evaluation Committee

J-RMP Maintenance as Seen from Company Case Studies - Proposals for Appropriate Drug Risk Management (March 2022 edition)" is now available.

Drug Evaluation Committee

Information session on "Let's learn about "Drugs" and "Clinical Trials"" on November 27, 2021. Public materials are now available.

Announcement Public Affairs Committee

YELL for New Drugs", a tie-up with Tokyo Graffiti, is now available.

Announcement Public Affairs Committee

Videos #5-#8 of "Learning with Pharmacy Student Aoito: Innovation of New Drugs" are now available.

Drug Evaluation Committee

The "Briefing Session on the Revised Pharmaceuticals and Medical Devices Act -Responses, etc. required of pharmaceutical companies based on notices and examples-" held on February 22, 2022 is now available.

Drug Evaluation Committee

The "Information Meeting on the Revised Pharmaceuticals and Medical Devices Act -Impact of the Introduction of Investigational New Drugs on Clinical Trials-" on February 22, 2022 is now available.

Drug Evaluation Committee

Clinical Trial 119: Q&A update: "Wash-out before obtaining consent

Announcement

DATA BOOK 2022 (Japanese)" is now available.

Drug Evaluation Committee

Presentation materials for "The 10th Data Science (DS) Subcommittee Assembly (Symposium) Part 1" are now available.

Drug Evaluation Committee

The following pages are released: "Current Status and Considerations for Introducing RPA into PV Operations" (February 2022).

Pharmaceutical Industrial Policy Committee

Status of Approval and Development of Therapeutic Products and Vaccines" has been updated.

Announcement

JPMA's Video Contents" has been updated.

Announcement Code Compliance Committee

Transparency Guideline (Revised on January 20, 2022)" is available.

Drug Evaluation Committee

Workshop for Practitioners on Electronic Data Submission at the Time of Filing Application" (Japanese only) is now available.

Announcement Public Affairs Committee

Videos #1 to #4 of "New Drug Innovation with Aoi, a Pharmacy Student" are now available.

ICH Project

Briefing on eCTD v4.0 (ICH M8) Notification Revision and Start of Operation" is now available.

Pharmaceutical Industrial Policy Committee

Status of Approval and Development of Therapeutic Products and Vaccines" has been updated.

Drug Evaluation Committee

Slide book "How to Introduce and Utilize Clinical Trial Methods that Do Not Require Visits to Medical Institutions" is now available.

Drug Evaluation Committee

PMDA Reliability Assurance Department's "GPSP Information Session 2022" is now available.

Drug Evaluation Committee

Matching Adjusted Indirect Comparisons: Is the Population Adjustment Method Useful? -Matching Adjusted Indirect Comparison and Simulated Treatment Comparison-" is posted.

Announcement Public Affairs Committee

JPMA Newsletter No. 207" is now available.

Drug Evaluation Committee

Guidance for Remote Investigation (Reexamination)" (January 2022) is now available.

Drug Evaluation Committee

Clinical Trial 119: Q&A update: "Substitution of a Consent Document by a Person Equivalent to a Substitute Consentor

Drug Evaluation Committee

The 39th Patient Group Seminar (Online) Video Streaming" (Japanese only) is now available.

Patient Cooperation Committee

The 39th Patient Group Seminar (Online) Video Streaming" is now available.

Pharmaceutical Industrial Policy Committee

Newly added "Related Information on New Coronavirus Infections" (Japanese)

ICH Project

The 44th ICH Public Meeting (Web-based)" is now available.

Drug Evaluation Committee

The "Guidance for Conformity Assessment" (November 2021) is now available.

Announcement Public Affairs Committee

The Asahi Shimbun Company "Oshigoto Nenkan 2021" has been added.

ICH Project

ICH Q12 "Guideline Workshops on Technical and Regulatory Approaches to Life Cycle Management of Pharmaceuticals" is now available.

Drug Evaluation Committee

The following pages are released: "Introduction and Modeling of NICE TSD - Collection and Review of Evidence for Modeling -" (Japanese only)

Drug Evaluation Committee

The 139th Assembly of the Drug Evaluation Committee" is now available.

International Affairs Committee

The "9th Taiwan-Japan Pharmaceutical Exchange Conference" is now available.

Announcement Public Affairs Committee

The 15th Survey on Sei-katsu-sha Attitudes Toward Drugs and the Pharmaceutical Industry" is now available.

Announcement Public Affairs Committee

JPMA Newsletter No.206" has been released.

Drug Evaluation Committee

Guidance for Application for Reexamination" is now available.

Regulatory Affairs Committee

Report on the Results of the Questionnaire Survey on the Review Status of New Drugs at the Pharmaceuticals and Medical Devices Agency - January 2021 Survey -" is now available.

Drug Evaluation Committee

Publication of "Drug Development Based on Patients' Opinions" Symposium for Pharmaceutical Companies.

News Release Code Compliance Committee

JPMA Code of Practice "Month to Promote Understanding of the JPMA Code of Practice"" is now available.

Drug Evaluation Committee

Newly added "Introduction to NICE TSD, Quality of Life Values - Measurement of Quality of Life Values and Use of Quality of Life Values for Cost-Effectiveness Analysis".

Drug Evaluation Committee

Clinical Trial 119: Q&A update: "Necessity of Investigational Review Committee Review of Changes to Clinical Trial Protocol after Clinical Trial Completion

Drug Evaluation Committee

Clinical Trial 119: Q&A update: "Review by the Clinical Trial Review Committee on the Deletion of a Clinical Research Assistant" (Japanese)

Drug Evaluation Committee

Clinical Trial 119: Q&A update: "Obtaining Consent on or after April 1, 2022

Drug Evaluation Committee

Guidance for Periodic Safety Reporting" is now available.

Announcement

Newspaper Advertisement" is posted.

Announcement ICH Project

Information on "ICH Quality Forum" is now available.

International Affairs Committee

Event related to WHO Western Pacific Regional Committee" is now available.

Announcement Public Affairs Committee

JPMA Newsletter No. 205" is now available.

ICH Project

Guideline Workshops on "ICH Q13: Draft Guideline for Continuous Manufacturing of Drug Substances and Drug Products" reached in Step 2" is now available.

ICH Project

Briefing on ICH S5 and S11" is now available.

Drug Evaluation Committee

Manual for Notification of Electronic Drug Information for Prescription Drugs (August 2021 version)" is now available.

Drug Evaluation Committee

Japanese Translation of FDA Guidance on Adaptive Design" is now available.

Announcement International Affairs Committee Public Affairs Committee

JPMA Guide 2021 English/Chinese version" is now available.

International Affairs Committee

AMR Action Fund Japanese website is now available.

Announcement International Affairs Committee

IFPMA's Vaccines Confidence Digital Campaign" is updated.

Drug Evaluation Committee

3 Q&A received in Clinical Trial 119 after July 19, 2021" is now available.

Drug Evaluation Committee

The following pages are released: "Study on the Use of Clinical Trial Methods that Do Not Depend on Visits to Medical Institutions: A Guide for Introduction in Japan" (Japanese only).

ICH Project

The "Guideline Workshops on the Draft Guideline "Nonclinical Biodistribution Considerations for Gene Therapy Products" Reaching ICH S12: Step 2" was posted.

Drug Evaluation Committee

Q&A on 3 Q&A received in Clinical Trial 119 on or after March 22, 2021" is posted.

Drug Evaluation Committee

Starting Today! Process Management of Clinical Trials at Medical Institutions" has been added.

ICH Project

Guideline Workshops" has been updated.

ICH Project

Public Meetings" has been updated.

Announcement Public Affairs Committee

JPMA Newsletter No. 204" is now available.

Drug Evaluation Committee

MA Subcommittee TF3 Deliverable "Q&A on the Implementation of Medical Education Meeting and Medical Booth" is now available.

Quality & Technology Committee

The deliverable "Serial Production Project Deliverables" has been released.

Drug Evaluation Committee

The "Pharmaceutical Risk Management Plan (RMP): Considerations for Evaluating the Effectiveness of Additional Risk Minimization Activities (Materials)" is now available.

Drug Evaluation Committee

Guidance for Preparation of Defect Reports Related to Drug Substance Combination Products (2021 Edition)" is now available.

Drug Evaluation Committee

"Information Meeting on Revision of the Pharmaceuticals and Medical Devices Act (related to Notification of Clinical Trials and Reporting of Adverse Reactions to Clinical Trials) (Webinar held on June 8, 2021)" is available.

Announcement Drug Evaluation Committee

YouTube Video: Innovative Changes in Data Management" is now available.

Public Affairs Committee

Event Report "JPMA/PhRMA/EFPIA Joint Press Conference" is now available.

Announcement Public Affairs Committee

JPMA Guide 2021" is now available.

Drug Evaluation Committee

Study Design and Statistical Evaluation Methods for Development of Regenerative Medicine Products" is now available.

News Release

JPMA Chairman's Press Conference on May 20" is available.

Announcement

Updated "Message from the Chairman" and "Board of Directors".

Drug Evaluation Committee

Guidance for Providing Information on "Electronic Drug Information Sheet for Prescription Drugs"-May 2021 Edition-is now available.

Announcement Public Affairs Committee

JPMA Newsletter No. 203" is now available.

Biopharmaceutical Committee

Analysis of Application Materials for Regenerative Medicine Product Approval (Life Cycle Management Information)" is available.

Drug Evaluation Committee

（New Drug Development Using Real World Data and Disease Registries" is added.

Drug Evaluation Committee

Innovative Changes in Data Management (Full Version)" is now available.

Intellectual Property Committee

The following pages are released: "IP PACT: (IP Principles for Advancing Cures and Therapies).

Announcement

Newspaper Advertisement" is posted.

Drug Evaluation Committee

Guidance for Preparation of Drug Risk Management Plan (J-RMP) - April 2021 Edition" is now available.

Announcement

Business Policy, Business Plan, and Implementation Plan" for FY2021 is now available.

Announcement

DATA BOOK 2021 English version" is now available.

Announcement Public Affairs Committee

DATA BOOK 2021 English Version" was released.

Drug Evaluation Committee

Q&A received on Clinical Trial 119 after February 8, 2021" is now available.

Drug Evaluation Committee

Symposium on Causal Inference for Understanding ICH-E9(R1)" (March 2021) is now available.

Drug Evaluation Committee

Explanation of Revisions to Notification Concerning Reexamination, Periodic Safety Reporting, and Conformity Surveillance in FY2020" (March 2021) is now available.

Announcement

JPMA Policy Proposal 2021" is now available.

Announcement

DATA BOOK 2021 Japanese" has been released.

Announcement Public Affairs Committee

JPMA Newsletter No. 202" has been released.

International Affairs Committee

Global Health Issues" in Global Health has been updated.

International Affairs Committee

Universal Health Coverage" in Global Health has been updated.

International Affairs Committee

Global Health Issues (Infographics)" by Global Health has been updated.

International Affairs Committee

IFPMA's "#Team Vaccines" campaign video is now available.

International Affairs Committee

IFPMA's #Team Vaccines website is now available.

International Affairs Committee

IFPMA's "Vaccines Confidence Digital Campaign" is now available.

Drug Evaluation Committee

Study on Data De-identification Methodology for Clinical Trial Data Sharing (CTDS)" is now available.

Code Compliance Committee

Summary of Results of Questionnaire Follow-up Survey on GL for Marketing Information Provision Activities (conducted in November 2020)" is now available.

Announcement Drug Evaluation Committee

The 5th edition of "Drugs and Clinical Trials" is now available.

Drug Evaluation Committee

2 Q&A received in Clinical Trial 119 after December 29, 2020" is posted.

Drug Evaluation Committee

Resource Collection of Documents Related to CDISC and Electronic Data Submission (4th Edition) (February 2021)" is posted.

Drug Evaluation Committee

Notice of Publication of "Guide to Creating XML Files for Notification of Clinical Trials (4th Edition)" is now available.

Drug Evaluation Committee

Workshop for Practitioners on Electronic Data Submission at the Time of Application" (February 2021) has been posted.

Announcement Public Affairs Committee

JPMA Newsletter No. 201" is now available.

Drug Evaluation Committee

3 Q&A received in Clinical Trial 119 after November 26, 2020 have been posted.

Pharmaceutical Industrial Policy Committee

The following pages are released / updated: "Proper Use of Medicines" (Japanese only)