Year 2024 Update

NHI Drug Price Revision for FY2025

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

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

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

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

Report on "BioJapan 2024" is now available.

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

The 50th ICH Immediate Report Meeting (Web-based)" is updated.

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

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

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

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

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

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.

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

Article on the WIPO Treaty on GRATK in the November issue of JIPA's "Intellectual Property Management" magazine" is now available.

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

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

Participation in the "Pharmaceutical Visionary Conference 2024
Aiming for Dialogue and Co-creation by Diverse Stakeholders" is posted.

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.

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

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

Joint Statement by the three pharmaceutical organizations of Japan, the U.S., and Europe: Opinions on the FY2025 NHI Mid-Year Revision and National Strategies

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

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.

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

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

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.

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

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

About "Survey on Healthcare Professionals' Concerns in Rare Diseases

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.

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

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

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

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

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

JPMA Code of Practice "Code Understanding Promotion Month

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

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

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

The "JPMA Press Conference on October 8" is now available.

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

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

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

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

JPMA Newsletter No. 223" has been released.

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

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

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

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

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

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

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

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

The 49th ICH Immediate Report Meeting (Web-based)" has been updated.

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

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

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

JPMA Newsletter No. 222" is now available.

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

ICH M14 Guideline Workshops" has been updated.

The "Efforts to Eliminate Drug Losses" proposed by the MHLW's Study Council on Unapproved and Off-label Drugs of High Medical Need

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

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

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

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

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

ICH M14 Guideline Workshops" is now available.

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

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

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

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

Voluntary Action Plan for Optimization of Distribution and Productivity Improvement" was published.

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

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"".

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

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

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

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

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

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

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

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

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

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

JPMA Guide 2024" is now available.

JPMA Newsletter No. 221" is now available.

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.

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

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

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.

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

The 49th ICH Immediate Report Meeting" is updated.

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

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

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

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

Simulation for Planning Adaptive Design" is now available.

The following pages are released: "Efficient Creation of CSV Documents Using Vendor Documents" (Japanese only)

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

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

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.

Global Health Issues" is updated.

Updated " JPMA Position Statements".

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

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

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

ICH E2D(R1) Guideline Workshops" was added.

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

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

Glossary of Health and Medical Data" is now available.

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

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

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

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

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

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

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

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

JPMA Newsletter No. 220" is now available.

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

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.

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

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

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

DATA BOOK 2024" is now available.

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

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.

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.

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

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

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.

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

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

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

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

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

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

Lecture "Quality by Design and Consistent Quality Management in Clinical Trials: From the Perspective of Both Sponsors and Clinical Laboratories" on January 18, 2024 has been added.

Symposium on ICH E19 "Selective Approaches to Safety Data Collection in Certain Clinical Trials Conducted Before or After Approval in the Late Phase of Development" was updated.

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

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

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.

JPMA Newsletter No. 219" is now available.

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

The Noto Peninsula Earthquake of 2024

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

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