Year 2024 Update

NHI Drug Price Revision for Fiscal 2025 (FY2025)

Report on "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 published.

Report on "Symposium of the Annual Meeting of the Drug Evaluation Committee 2024" is now available.

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

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

Newly added: "Educational Material on Whole Genome Analysis and Genomic Medicine" (Japanese only)

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 Strategy

The 14th Annual Meeting of the Regulatory Science Society of Japan" is now available.

The Pharmaceutical Manufacturers Association of Japan (PAPJ) 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 on the Introduction of a Pull-type Incentive System in the Antimicrobial Market" is now available.

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

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

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.

Survey on the Problems of Healthcare Professionals 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 Needs of R&D Committee Member Companies" was updated.

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

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

The following pages are released / "The Pharmaceutical Association of Japan Code of Practice "Code Understanding Promotion Month"" is released.

Newly added "Pharmaceuticals Consultation Study Group" on the Committee page.

"FY2024 Meeting of Code Administration Managers and Practitioners" is now available.

Video presentation of "Pharmaceutical Association of Japan Press Conference on October 8" is now available.

The "Press Conference on October 8, 2012 by the President of the Pharmaceutical Manufacturers Association of Japan" is now available.

The "Pharmaceutical Association of Japan PR and Communication Plan for 2024" is now available.

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

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

The Pharmaceutical Manufacturers Association of Japan (PMAJ) media forum "Life Course Immunization in the Era of 100-year Life Expectancy" is now available.

Pharmaceutical Manufacturers Association of Japan Newsletter No. 223" is now available.

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

The contents of the documents of "Carbon Neutral Action Plan" and "Voluntary Action Plan for Establishing a Recycling-Oriented Society" were updated.

The Pharmaceutical Consortium of Japan's 2nd (FY2024) "Open Call for Researcher Support and Grants" has been posted.

The "Reference: Creating a society where everyone has easy access to clinical trials" is now available.

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

R&D Needs of R&D Committee Member Companies" was 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 and Consideration of its Application to the GxP Field" is now available.

Pharmaceutical Manufacturers Association of Japan Newsletter No.222" has been released.

The following pages are released: "Outline and Key Points of the Ethical Guidelines for Life Sciences and Medical Research Involving Human Subjects" (Japanese only)

Updated "ICH M14 Draft Guideline Briefing Session" is available.

Approaches 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 available.

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

Public Information for FY2023 Payment" of "Transparency Guidelines for the Relationship between Corporate Activities and Medical Institutions" has been updated.

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

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

ICH M14 Draft Guideline Briefing" is now available.

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

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

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

To Pharmaceutical Companies Creating Documents for Non-specialists to Communicate Clinical Trial Information in an Easy-to-Understand Way" has been added.

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

Proposals for the Use of Digital Technology and Challenges in 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 the Survey on the 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: Creating a Society Where Clinical Trials are Accessible to All".

Proposal for 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 "Medical Device Program (SaMD) Development Overview: Organizing the Development Process and the Development Promotion System" is now available.

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

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

The "Pharmaceutical Cooperative Guide 2024" is now available.

Pharmaceutical Cooperative Association of Japan Newsletter No.221" has been released.

Symposium "Promotion and Optimization of the Introduction of Electromagnetic Systems - Don't miss the opportunity in the age of 100% electromagnetic systems! -" 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" (Japanese only)

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

Simulation for Planning Adaptive Design" is now available.

Newly added: "Efficient Creation of CSV Documents Using Vendor's Documents".

A new report from the Office of Health Economics (OHE) has been published: "Adult Immunization Programs Provide 19 Times the Socioeconomic Value of the Initial Investment".

Global Status and Initiatives" is updated.

Pharmaceutical Manufacturers Association of Japan Statement on Global Health" is updated.

Educational and Training Materials for E2B(R3) Commentary 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.

The following pages are released / updated: "ICH E2D (R1) Draft Guideline Briefing Session" (Japanese only)

"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.

Research and Development Needs of Research Committee Member Companies" 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.

Pharmaceutical Cooperative Association of Japan Newsletter 220" has been released.

Reference: Creating a Society Where Everyone Has Easy Access to Clinical Trials" is now available.

The "Event for raising awareness in the pharmaceutical and medical fields: "Living with Disease. Living with Hope. Photo Exhibition: "Living with Disease and Hope: Unseen Answers, Creating the Future" Second Event to be Held in Osaka" is now available.

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 Committee General Meeting Part 2: Clinical Part: Toward the Future" (2024/2/16: Web-based) is now available.

DATA BOOK 2024" is now available.

Policy Research Institute News No.71" is now available on the website of the Pharmaceutical and Industrial Policy Research Institute (PIIPRI).

The latest trend of regulation and review for programmed medical devices and the efforts of the Drug Evaluation Committee (Webinar: Feb. 8, 2024)" is 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 (Pharmaceutical Cooperative Electronic Model)" is now available.

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

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

Video presentation of "Pharmaceutical Association of Japan Press Conference on February 15" is now available.

The material of "Symposium on "Appropriate Understanding of ICHE19 and its Introduction in Japan" (Webinar: Jan. 30, 2024)" is 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 Questionnaire on Electronic Provision of Information - Trend of Pharmaceutical Manufacturers' Association 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)" material is posted.

Pharmaceutical Association of Japan Newsletter No.219" has been released.

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

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 the Pharmaceutical Association of Japan 2024" is now available.