Year 2025 Update Information

In Response to the Fiscal 2026 (FY2026) Reform of the NHI Drug Price System and Cost-Effectiveness Evaluation System

The 148th Annual Meeting of the Drug Evaluation Committee" is now available.

Asian eCTD / Gateway System Information" is posted.

Information on "World NTD Day 2026" Webinar is now available.

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

The "Results of Questionnaire on Information Provision Activities at the Time of Precautions for Use Revision" is now available.

The "Regular Meeting with the German Association of the Research-based Pharmaceutical Industry (vfa)

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 Fiscal 2026 (FY2026)

Review of the 10 years since the introduction of the RMP system from the standpoint of the pharmaceutical industry" is now available.

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

Information on "2026 Life Science IP Forum" is now available.

DX Lecture Slides (19th Annual Meeting of the Japanese Society of Pharmacognosy)" is posted.

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

R&D Needs of R&D Committee Member Companies" was updated.

The following pages are released: "Data Linkage Concept - Data Linkage from the Perspective of Overseas Regulations".

The "Guidance for 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)

The 15th Asian Pharmaceutical Association Conference (APAC)" visited three Southeast Asian countries.

Report on "The 44th Public Relations Seminar" is now available.

RMP Presentation Slides (27th Annual Meeting of the Japanese Society for Pharmaceutical Informatics)" is now available.

Issuance of Joint Statement "Clinical Trial Ecosystem Industry Declaration 2025

Report on "BioJapan 2025" and its participation

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

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 now available.

Report on Side Events Held during the UN General Assembly" is now available.

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

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

The 15th Asian Pharmaceutical Association Conference (APAC)" is now available.

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

eCTD v4 Preparation Guide Version 1.0" is now available.

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

Won third place in the "My CareerStudy Course Contest 2025. The Pharmaceutical Cooperative'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.

The "Pharmaceutical Manufacturers Association of Japan Newsletter No. 227" is now available.

Interviews with the Chairpersons of the Pharmaceutical Manufacturers Association of Japan (PMAJ) Industry Vision 2035" is now available.

Questionnaire Report on the Promotion of eSource Utilization such as Electronic Medical Records" is now available.

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

Report on "Two Major Issues in Countermeasures Against Infectious Diseases: Countermeasures against Drug-Resistant Bacteria and Proper Understanding of Immunization" (Japanese) 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 15th Annual Meeting of the Regulatory Science Society of Japan (RSCJ)" is now available.

Report on BioJapan2025 Luncheon Seminar "Meeting the Challenges of Access to Medicines: Co-creation between the Public and Private Sectors" is now available.

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

Pharmaceutical Association Code of Practice "Pharmaceutical Association Code Understanding Promotion Month

Participation in "Pharmaceutical Visionary Conference 2025
Discussions for Co-creation by Expanding the Circle of Stakeholders

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 implemented the Common Template for Explanatory and Consent Documents (ICF)" is released.

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

Reference: "Association for Creating a Society Where Everyone Has Easy Access to Clinical Trials" 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.

Publication of the book "Pharmaceutical Association Code of Practice (Revised May 2025)

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 of "Toward the Era of Co-Creation" <16> by Dr. Tsukahara, Chairman of the R&D Committee, was published in Nikkan Yakugyo.

Report on the "Pharmaceutical Cooperative Media Forum" is now available.

ICH Q3E "Draft Guideline for Extractables and Eluates of Drugs" Information Meeting" is 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 Dr. Murakami, Chairperson of the International Committee of the Japan Pharmaceutical Manufacturers Association (JPMA) was published.

The article by IP Committee Chair Okumura was published in the "Nikkan Yakugyo" (Daily Yakugyo).

The article by Mr. Nakaji, Chairman of the Committee on Pharmaceutical Evaluation, was published in Nikkan Yakugyo.

The report of "BioJapan 2025" was published in the "Pharmaceutical Association of Japan (PAK) Media Forum".

The article by Dr. Misawa, Chairperson of the Patient Groups Collaboration Promotion Committee, was published in Nikkan Yakugyo.

The article by Dr. Wakasugi, Chairperson of the Pharmaceuticals Consultation Committee, was published in the Nikkan Yakugyo (Daily Yakugyo) <11>.

The "Pharmaceutical Association of Japan Code of Practice (Revised May 2025)" book is published.

Notice on Election of New Board Members

The Quality Committee Chairman, Mr. Kawashima, was interviewed by Nikkan Yakugyo in an article entitled "Toward the Era of Co-Creation" <8>.

The report of "The 44th Public Relations Seminar" is now available.

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. The "Pharmaceutical Co-op Kusurium Laboratory 2025 Autumn" is a fun way to learn about pharmaceuticals. SNS campaign for free invitations is also underway!

The article by Mr. Kondo, Chairman of the Product Information Outline Review Committee, was published in the "Nikkan Yakugyo".

ICH Project Chair Yokota was interviewed by Nikkan Yakugyo.

The Environmental Issues Review Committee Chairman, Mr. Arima, was interviewed by Nikkan Yakugyo.

The article "Toward the Era of Co-Creation" <4> by Dr. Kashiwatani, Chairperson of the Pharmaceutical Affairs Committee, was published in Nikkan Yakugyo.

Reference: "Association for Creating a Society Where Everyone Has Easy Access to Clinical Trials" has been updated.

The "DIA 2025 Global Annual Meeting" was published on April 14, 2025.

The Science Museum's "Pharmaceutical Co-op Kusurium Laboratory 2025 Autumn" Invitation Campaign! is now available.

The article by Mr. Kumagai, Chairperson of the Distribution Optimization Committee, was published in the "Nikkan Yakugyo" (Daily Pharmaceutical Daily News).

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

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

Newspaper Advertisement" is now available.

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.

The Pharmaceutical Manufacturers Association of Japan, 3rd (FY2025) "Open Call for Researchers Support and Grant

The "Guidelines for Public Offers for Researcher Support and Grants in FY2025" is now available.

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

The "Transparency Guideline for the Relationship between Corporate Activities and Medical Institutions" for the payment in 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)

The "Pharmaceutical Association of Japan Industry Vision 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.

The Pharmaceutical Manufacturers Association of Japan (PMAJ) Sponsors the Senden Kaigi Award in the category of Junior High and High School Students -Creating the future of life together with the young generation who will lead the future

Report on the Results of Questionnaire Survey on "Inquiry Items for 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)

The "Senden Kaigi Award Junior High and High School Student Section: Orientation" is now available.

The "Pharmaceutical Manufacturers' Association Newsletter No.226" is now available.

Research report on the issue of drug-resistant bacteria 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".

ICH M4Q(R2) "Guideline for Preparation of CTD-Quality Document (Draft)" Briefing Session" is now available.

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

A Guide for Efficient Preparation of Regulatory Documents (CSR and CTD (Clinical Tables)) in Response to Changes in the Environment" is now available.

An article titled "To Deliver Necessary Drugs to Patients - Pharmaceutical Manufacturers Association Requests 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.

The 43rd Public Relations Seminar" report is available.

The report of "ICH Madrid Meeting" is available.

Information on "The 51st ICH Immediate Debriefing Session" is now available.

Report on "14th APAC (Asian Pharmaceutical Association Conference)" is now available.

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

The report of "What is Patient Experience Information Useful for Decision-Making in Drug Development" on June 13, 2025 is now available.

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

Following the Cabinet Decision on the "Framework Policy 2025

A report on the "Joint Meeting of the Drug Evaluation Committee and the Pharmaceutical Affairs Committee in 2025" is available.

Report on the "Pharmaceutical Association of Japan 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)".

Briefing on ICH Q1 "Draft Guideline for Stability Studies of Drug Substance and Preparations" (Step 2 document)" is now available.

President Kinoshita participated in a panel sponsored by "Endpoints News" in the U.S.

Video of the presentation at the "Pharmaceutical Association of Japan Press Conference on May 22nd" is now available.

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

Revision of the Pharmaceutical Association of Japan Code of Practice

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

The "Pharmaceutical Association of Japan Guide 2025" is now available.

The "Pharmaceutical Association of Japan Press Conference on May 22nd" is now available.

Notice on 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.

Reference] Association for Creating a Society Where Clinical Trials are Accessible to All" has been updated.

Newspaper and Digital Advertisements" has been updated.

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

Pharmaceutical Manufacturers Association of Japan 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.

The 14th Asian Pharmaceutical Association Conference (APAC)" is now available.

The "14th APAC Press Conference on April 23rd" 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)

Model Credibility Assessment in Drug Development" is now available.

Report on "The Pharmaceutical Manufacturers Association of Japan (PMAJ) Media Forum" is 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 Managers" has been re-published.

The "Future Drug Researchers are Born! The "Pharmaceutical Consortium of Japan Holds Popular "Pharmaceutical Research Laboratory in Kusurium"" is now available.

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 IP Forum" is now available.

The "FY2024 Clinical Evaluation Committee Meeting Part 2: Presentation Materials" is now available.

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

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

Report on the "Pharmaceutical Association of Japan 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.

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 Guidelines for the Relationship between Corporate Activities and Medical Institutions" is updated.

DATA BOOK 2025" is now available.

Video presentation of "Pharmaceutical Association of Japan Press Conference on February 26th" is now available.

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

The "Press Conference on February 26th by the President of the Pharmaceutical Manufacturers Association of Japan (PMAJ)" is now available.

The Pharmaceutical Manufacturers Association of Japan (PMAJ) Industry Vision 2035 and PMAJ Policy Recommendations 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! Information on the "Pharmaceutical Association of Japan 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 implemented the Common Template for Explanatory and Consent Documents (ICF)" is released.

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 Briefing Session" on April 16, 2025 Web-based "ICH M10 Guideline Briefing Session" is now available.

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

R&D Needs of R&D Committee Member Companies" was updated.

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

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

APAC Project" was newly added to the Committee page.

Report on OSS Usage Questionnaire 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: Feb. 26, 2025) 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 President of the Pharmaceutical Association of Japan 2025" is now available.