2023 Update Information

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 now available.

The 48th ICH Immediate Report Meeting" is updated.

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

The 17th Survey on Sei-katsu-sha Attitudes Toward Drugs and the Pharmaceutical Industry

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)

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

ICH Q9(R1) Guideline Briefing" is available.

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

ICH S12 Guideline Briefing" is now available.

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

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

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

Presentation materials for the 143rd Annual Meeting of the Committee on Drug Evaluation "Breakthrough to Drug Lag/Loss: Toward the Realization of Safe, Secure, and Well-Being Medicine and Society" are now available.

The presentation materials for the "Pharmaceuticals and Medical Care Awareness Event: Living with Disease, Living with Hope. Living with Hope. Photo Exhibition: "Living with Disease, Living with Hope: Unseen Answers for the Future"" is now available.

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.

The "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.

Pharmaceutical Manufacturers Association of Japan 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.

Industry Standard Manual" has been updated.

Policy Research Institute News No.70" is now available on the website of the Pharmaceutical and Industrial Policy Research Institute (PIIPRI).

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

Updated "ICH Q9(R1) Guideline Briefing Session.

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.

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

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 on 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".

Revised "Guidelines for Preparation of Outline of Product Information for Ethical Drugs" is available.

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

Pharmaceutical Manufacturers Association of Japan Newsletter No. 217" has been released.

Public Call for Researchers Support and Subsidies" is now available.

The "Public Call for Researcher Support and Subsidies" by the Pharmaceutical Manufacturers Association of Japan (PMAJ) is now available.

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

The following pages are released / updated: "Explanatory Material on Basic Matters for Utilization of eTMF (electronic Trial Master File) and TMF Metrics" (Japanese only)

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

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".

The following pages are released: "Composition of the CTD using the results of global clinical trials based on the principles of ICH E17".

ICH E6(R3) Briefing on the Draft Guideline for "Standards of Conduct for Clinical Trials of Medicinal Products"" 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 Ethical Drugs" is available.

Efforts for Intractable and Rare Diseases" was updated.

Proposal on Intractable and Rare Diseases" by the Pharmaceutical Manufacturers Association of Japan (PMAJ) is now available.

The following pages are released / "Global Status and Initiatives 2023" (Japanese only)

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

The following pages are released: "Ensuring Effective and Efficient Clinical Trial Quality Based on the Quality by Design Concept: Aiming for Consistent Quality Management from Planning to Implementation".

Pharmaceutical Cooperative 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 Session Document" held on Tuesday, June 27, 2023 is now available.

Policy Research Institute News No.69" has been posted on the website of the Pharmaceutical and Industrial Policy Research Institute (PIRI).

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

Newspaper Advertisement" is now available.

Flexible Survival Time Modeling Method 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"

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

The following pages are released: "What Clinical Data Managers should look like and skill sets for the future: Focusing on Vendor Oversight, QMS, and DCT" (Japanese only)

Video presentation of "Pharmaceutical Association of Japan 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.

The "Pharmaceutical Association of Japan Guide 2023" is now available.

Notice on Election of New Board Members

Multivariate meta-analysis and alternative endpoints in medical technology assessment" is now available.

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

Pharmaceutical Cooperative Association of Japan 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)" were added.

Newspaper Ads" and "Digital Ads" are available.

The 106th Annual Meeting of the Clinical Evaluation Committee [Part 2] New Normal Clinical Trial: Optimization and Efficiency of Clinical Trials triggered by COVID-19" is now available.

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 Therapeutics and Vaccines" is 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, is now available.

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

The "Pharmaceutical Manufacturers Association Compliance Program Guideline" 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 Drug Price 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 Self-Inspection of Non-clinical Trials_ver.1" is now available.

A link to the R&D Head Club "Calculation of Clinical Trial Costs Based on Fair Market Value" homepage is available in "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)

Pharmaceutical Cooperative Association of Japan Newsletter No. 214" has been released.

eCTD v4.0 Educational Material", a deliverable of TF1 of the Electronic Information Subcommittee, is now available.

DATA BOOK 2023" is now available.

Policy Research Institute News No.68" is now available on the website of the Pharmaceutical and Industrial Policy Research Institute (PIRI).

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 are now available.

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

Video of Presentation at the Pharmaceutical Association of Japan Press Conference on February 16, 2011" is available.

Statistical Inference for Adaptive Design" is now available.

Policy Proposal 2023" is now available.

The "Pharmaceutical Association of Japan Press Conference on February 16, 2011" is now 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.

The "Survey on the problems of patients with rare diseases" by the Pharmaceutical Manufacturers Association of Japan (PMAJ) is now available.

Newspaper Advertisement" is now available.

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 posted.

Newspaper Advertisement" is now available.

Presentation materials for "Explanatory Meeting on the 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 Issues Study Group" is newly established.

Status of Approval and Development of Therapeutics and Vaccines" is updated.

Pharmaceutical Manufacturers Association of Japan 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 Pharmaceutical Manufacturers Association of Japan (PMAJ)" is now available.