Year 2025 Update Information

In response to the reform of the NHI drug price system and cost-effectiveness evaluation system in fiscal 2026 (FY2026)

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

Asian eCTD / Gateway System Information" was added.

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

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

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

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

Joint Statement by the three pharmaceutical organizations of Japan, the U.S., and Europe: Opinions on Reform of the NHI Drug Price System and Cost-Effectiveness Evaluation System in FY2026 (fiscal year 2026)

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)

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

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

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

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

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

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

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

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

Report on the 44th Public Relations Seminar

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

Issuance of Joint Statement "Clinical Trial Ecosystem Industry Declaration 2025

Report on "BioJapan 2025" is now available.

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

"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.

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

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

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

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

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

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

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

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

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

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

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

JPMA Newsletter No. 227 is now available.

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

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

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

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.

On the Occasion of the Inauguration of the New Prime Minister Sanae Takaichi

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

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

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".

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

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

Nihon Keizai Shimbun published "My Leadership Essay".

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

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

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

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

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

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

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

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

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

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

Report on "JPMA Media Forum" is now available.

ICH Q3E Guideline Workshops on "Draft Evaluation and Control of Extractables and Leachables of Pharmaceutical and Biological Products" are now available.

Scientific Discussion on FDA Review Report" was added.

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

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

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

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

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

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

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

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

Election of New Board Members

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

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

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

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!

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 Chairperson Mr. Yokota was interviewed by Nikkan Yakugyo.

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

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

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

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

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

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

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

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

Newspaper Advertisement" is posted.

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

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

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

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

The "Guidelines for FY2012 Open Call for Researcher Support and Subsidies" is now available.

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

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

Reporting Form for Pharmacovigilance Regulation Survey" is now available.

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

JPMA's Vision for 2035" is now available.

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

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

Lecture "Clinical Trial 119" is now available.

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.

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.

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

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

JPMA Newsletter No.226" went online.

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

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

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

ICH M4Q(R2) "Guideline Workshops on CTD-Quality Documentation Procedure (Draft)" is now available.

Selected as a "Model Project for Promoting Decarbonization along the Entire Value Chain" by the Ministry of the Environment of Japan
～12 companies to participate in the establishment of common rules for calculating CO2 emissions in the pharmaceutical industry

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

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

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.

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

ICH E21 "Inclusion of Pregnant and Lactating Women in Clinical Trials (Draft)" Information Session" is now available.

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

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

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

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

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

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

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.

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

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.

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

The report of "ICH Madrid Meeting" is available.

Information on "The 51st ICH Immediate Report Meeting" is now available.

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

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

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

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

In Response to the Cabinet Decision on "Kotta Policy 2025

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

JPMA Presidents Press Conference" is now available.

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

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

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

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

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

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

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

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

JPMA Code of Practice Revision

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

JPMA Guide 2025" is now available.

JPMA Press Conference on May 22" is now available.

Election of New Board Members

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

Managing Director Ishida spoke at an online event for students.

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

Newspaper and Digital Advertisements" has been updated.

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

JPMA Newsletter No. 225" is now available.

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

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

Newspaper and Digital Advertisements" has been updated.

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

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

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

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

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

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

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

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

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

Report on "JPMA Media Forum" is now available.

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

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

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

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

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

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.

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

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

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

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

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

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

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

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

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

JPMA Presidents Press Conference" is now available.

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

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

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

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

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

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

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

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

The Second Neglected Tropical Diseases Contest" is now available.

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

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

DATA BOOK 2025" is now available.

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

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

The "JPMA Press Conference on Feb. 26th" is now available.

JPMA's Vision for 2035" and "JPMA's Policy Proposals for 2025

The 18th Survey on Sei-katsu-sha Attitudes toward Drugs and the Pharmaceutical Industry

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

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.

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

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

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

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

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

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.

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

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

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

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

JPMA Newsletter No. 224" is now available.

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

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

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

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

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.

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.

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

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

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

Report on "ICH Montreal Meeting" is now available.

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.

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

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

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

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

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