Year 2023 Update

Guidance for Conformity Surveys including Reexamination (Ver 2.0, created in December 2023) is now available.

Quality Control - Fraud Detection Prevention" is now available.

Newspaper Advertisement" is posted.

The 48th ICH Immediate Report Meeting" is updated.

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

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

Joint Statement by the three pharmaceutical organizations of Japan, the U.S., and Europe on Reform of the NHI Drug Price System and Cost-Effectiveness Evaluation System in Fiscal 2024 (FY2024)

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

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.

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

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

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

ICH S1B (R1) Guideline Workshops" is available.

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

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

ICH S12 Guideline Workshops" is available.

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

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

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

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.

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

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.

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.

JPMA Newsletter No.218" is now available.

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

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

The "Industry Standard Manual" has been updated.

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

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

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

The 48th ICH Immediate Report Meeting" is updated.

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

JPMA Code of Practice "Code Understanding Promotion Month

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

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

Global Health Stakeholders" was updated.

Survey of Model-Informed Drug Development through Research on Products Approved in Japan" is now available.

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

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

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

JPMA Newsletter No. 217" has been released.

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

JPMA "Open Call for Researcher Support and Subsidies

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

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

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

The "Industry Standard Manual" has been updated.

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

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".

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

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

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

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

The 48th ICH Immediate Reporting Meeting" is posted.

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

Efforts for Intractable and Rare Diseases" was updated.

JPMA "Proposal on Intractable and Rare Diseases

2023 " is now available.

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

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.

JPMA Newsletter No. 216" has been released.

The 47th ICH Sessional Meeting" is updated.

The 47th ICH Immediate Debriefing Session" is now available.

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

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

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

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

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

Newspaper Advertisement" is posted.

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

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

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).

Joint statement by the three pharmaceutical organizations of Japan, the U.S., and Europe on the "Draft Report of the Expert Panel on Comprehensive Measures to Achieve a Rapid and Stable Supply of Pharmaceuticals" (Japanese only)

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

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

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

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

JPMA Guide 2023" is now available.

Election of New Board Members

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

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

JPMA Newsletter No. 215" has been released.

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

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

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.

Revision of the classification of novel coronaviruses under the Infectious Diseases Control Law" is now available.

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

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

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.

Publication of "Health and Medical Data and Our Lives," an educational booklet for the general public on the use of health and medical data.

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

JPMA Compliance Program Guidelines" was revised.

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

Research and Proposal on the Contribution of the Pharmaceutical Industry to Extending Healthy Life Expectancy and Driving Economic Growth: Toward the Future of the Pharmaceutical Industry" is now available.

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

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

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

Joint Statement by the three pharmaceutical organizations of Japan, the U.S., and Europe, "Proposals for the FY2024 NHI Reform" is now available.

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

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

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

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

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

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".

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

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

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

JPMA Newsletter No. 214" has been released.

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

DATA BOOK 2023" is now available.

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

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

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

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

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

Statistical Inference for Adaptive Design" is now available.

JPMA Policy Proposal 2023" is now available.

JPMA Press Conference on February 16, 2011" is available.

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.

Survey on the problems of patients with rare diseases" is now available.

JPMA "Survey on the problems of patients with rare diseases

Newspaper Advertisement" is posted.

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.

Newspaper Advertisement" is posted.

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.

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

Results of Legal Compliance Questionnaire" is posted.

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

Environmental Issue Committee" is newly established.

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

JPMA Newsletter No. 213" has been released.

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

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

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

New Year's Greetings from the President of the JPMA for the year 2023" is now available.