2021 Update Information
-
Drug Evaluation Committee
The 39th Patient Group Seminar (held online) video streaming" is now available.
-
Patient Organization Collaboration Promotion Committee
The 39th Patient Group Seminar (Online) Video Streaming" is now available.
-
Press Release
The "Fiscal 2022 Reform of the NHI Drug Price System" is now available.
-
Industry Policy Committee
Newly added "Related Information on New Coronavirus Infections" (Japanese)
-
ICH Project
The 44th ICH Immediate Report Meeting (Web-based)" is now available.
-
International Committee
A report on "Survey on Public Awareness of AMR and Antimicrobial Drug Development" is now available.
-
Drug Evaluation Committee
The "Guidance for Conformity Assessment" (November 2021) is now available.
-
Announcements
The Asahi Shimbun Company "Oshigoto Nenkan 2021" has been added.
-
ICH Project
ICH Q12 "Guidelines for Technical and Regulatory Approaches to Life Cycle Management of Pharmaceuticals" Briefing Session" is now available.
-
Drug Evaluation Committee
The following pages are released: "Introduction and Modeling of NICE TSD - Collection and Review of Evidence for Modeling -" (Japanese only)
-
Drug Evaluation Committee
The 139th General Meeting of the Committee on Drug Evaluation" materials are now available.
-
International Committee
The "9th Taiwan-Japan Pharmaceutical Exchange Conference" is now available.
-
Announcements
The 15th Survey on Sei-katsu-sha Attitudes Toward Drugs and the Pharmaceutical Industry
-
Announcements
The 15th Survey on Sei-katsu-sha Attitudes Toward Drugs and the Pharmaceutical Industry" is now available.
-
Announcements
The "Pharmaceutical Manufacturers Association of Japan Newsletter No.206" is now available.
-
Drug Evaluation Committee
The "Guide to Application for Reexamination" is now available.
-
Regulatory Affairs Committee
Report on the Results of the Questionnaire Survey on the Review Status of New Drugs at the Pharmaceuticals and Medical Devices Agency - January 2021 Survey -" is now available.
-
Drug Evaluation Committee
Publication of "Drug Development Based on Patients' Voices" Symposium for Pharmaceutical Companies.
-
Announcements
The following pages are released / "The Pharmaceutical Association of Japan Code of Practice "Code Understanding Promotion Month"" is released.
-
Drug Evaluation Committee
The following pages are released: "Introduction to NICE TSD, Quality of Life Values - Measurement of Quality of Life Values and Use of Quality of Life Values for Cost-Effectiveness Analysis" (in Japanese).
-
Drug Evaluation Committee
Clinical Trial 119: Q&A update: "Necessity of the Investigational Review Committee's review of changes to the study protocol after the completion of a clinical trial" was posted.
-
Drug Evaluation Committee
Clinical Trial 119: Q&A update: "Review by the Clinical Trial Review Committee on the deletion of a subinvestigator" (Japanese)
-
Drug Evaluation Committee
Clinical Trial 119: Q&A update: "Obtaining consent on or after April 1, 2022
-
Drug Evaluation Committee
Guidance for Periodic Safety Reporting" is now available.
-
Announcements
Newspaper Advertisement" is now available.
-
ICH Project
Information on "ICH Quality Forum" is available.
-
Announcements
Disciplinary Action against a Member Company" is posted.
-
International Committee
Holding of "Event related to WHO Western Pacific Regional Committee
-
Announcements
ICH Newsletter No. 205" is now available.
-
Announcements
Following the release of the "Pharmaceutical Industry Vision 2021
-
ICH Project
Information on "ICH Q13: Draft Guideline for the Continuous Production of Active Pharmaceutical Ingredients and Dosage Forms (Draft Guideline)" is now available.
-
ICH Project
ICH S5/S11 Briefing Session" is now available.
-
Announcements
The website of the Pharmaceutical Manufacturers Association of Japan (PMAJ) has been renewed.
-
Drug Evaluation Committee
Manual for Notification of Electronic Drug Information for Prescription Drugs (August 2021 version)" is now available.
-
Drug Evaluation Committee
Japanese Translation of FDA Guidance on Adaptive Design" is now available.
-
Quality Committee
Information on "GMP Case Study Workshop in FY2021 (for related organizations)" is now available.
-
Quality Committee
Information on "FY2021 GMP Case Study Workshop (for the press)" is now available.
-
Announcements
The "Pharmaceutical Manufacturers Association Guide 2021 English/Chinese version" is now available.
-
International Committee
AMR Action Fund Japanese website is now available.
-
Announcements
IFPMA's Vaccines Confidence Digital Campaign" is updated.
-
Drug Evaluation Committee
3 Q&A received in Clinical Trial 119 after July 19, 2021" is now available.
-
Drug Evaluation Committee
The following pages are released: "Study on the Use of Clinical Trial Methods that Do Not Depend on Visits to Medical Institutions: A Guide for Introduction in Japan" (Japanese only).
-
ICH Project
Briefing session on "ICH S12: Draft Guideline for Reaching Step 2: Concept of Non-clinical Biodistribution Studies of Gene Therapy Products" is now available.
-
Drug Evaluation Committee
Handbook for Regulatory Requirements and Publications of Electronic Information" is now available.
-
Code Compliance Promotion Committee
The "Transparency Guideline for the Relationship between Corporate Activities and Medical Institutions" "Public Information for FY2020 Payments" has been updated.
-
Announcements
The "Transparency Guideline for the Relationship between Corporate Activities and Medical Institutions" "Public Information for FY2020 Payments" has been updated.
-
Patient Organization Collaboration Promotion Committee
The "Transparency Guidelines for the Relationship between Corporate Activities and Patient Groups" "Disclosure Information for FY2020 Payments" has been updated.
-
Drug Evaluation Committee
Q&A on 3 Q&A received in Clinical Trial 119 on or after March 22, 2021" is posted.
-
Announcements
The "Transparency Guidelines for the Relationship between Corporate Activities and Patient Groups" "Disclosure Information for FY2020 Payments" has been updated.
-
Announcements
Disciplinary Action against a Member Company" is posted.
-
Drug Evaluation Committee
Starting Today! Process Management of Clinical Trials at Medical Institutions" has been added.
-
ICH Project
Guideline Briefing Session" has been updated.
-
ICH Project
List of Immediate Debriefing Sessions" has been updated.
-
Announcements
Pharmaceutical Manufacturers Association Newsletter No. 204" is now available.
-
Announcements
Information on the Cancellation of the Press Conference after the 556th Meeting of the Board of Directors of the Pharmaceutical Manufacturers Association of Japan (PMAJ)" is now available.
-
Drug Evaluation Committee
MA Subcommittee TF3 Deliverable "Q&A on the Implementation of Medical Education Meeting and Medical Booth" is now available.
-
Announcements
Information on "The 556th Post-Meeting Press Conference of the Board of Directors of the Pharmaceutical Manufacturers Association of Japan" is now available.
-
Quality Committee
The deliverable "Serial Production Project Deliverables" has been released.
-
Drug Evaluation Committee
The "Pharmaceutical Risk Management Plan (RMP): Considerations for Evaluating the Effectiveness of Additional Risk Minimization Activities (Materials)" is now available.
-
Drug Evaluation Committee
Guidance for Preparation of Defect Reports Related to Drug Substance Combination Products (2021 Edition)" is now available.
-
Drug Evaluation Committee
"Information Meeting on Revision of the Pharmaceuticals and Medical Devices Act (related to Notification of Clinical Trials and Reporting of Adverse Reactions to Clinical Trials) (Webinar held on June 8, 2021)" is available.
-
Announcements
YouTube Video: Innovative Changes in Data Management" is now available.
-
Announcements
Event Report "JPMA/PhRMA/EFPIA Joint Press Conference" is now available.
-
Announcements
The "Pharmaceutical Manufacturers Association Guide 2021" is now available.
-
Drug Evaluation Committee
Study Design and Statistical Evaluation Methods for Development of Regenerative Medicine Products" is now available.
-
Announcements
The "EFPIA Chairman's Press Conference on May 20" is now available.
-
Announcements
New Directors Election" is available.
-
Announcements
The following pages are released / "The Pharmaceutical Association of Japan Industry Vision 2025 Supplementary Edition" is posted on the website.
-
Announcements
Updated "Message from the Chairman" and "Board of Directors".
-
Drug Evaluation Committee
Guidance for Providing Information on "Electronic Drug Information Sheet for Prescription Drugs"-May 2021 Edition-is now available.
-
Announcements
Pharmaceutical Manufacturers Association of Japan Newsletter No. 203" is now available.
-
Announcements
The method of holding the "May 20 Press Conference of the Presidents of the Pharmaceutical Manufacturers Association of Japan" has been changed.
-
Announcements
WTO Waiver of Intellectual Property Rights" is now available.
-
Biopharmaceutical Committee
Analysis of Application Materials for Regenerative Medicine Product Approval (Life Cycle Management Information)" is available.
-
Announcements
(New Drug Development Using Real World Data and Disease Registries" is added.
-
Drug Evaluation Committee
Innovative Changes in Data Management (Full Version)" is now available.
-
Announcements
Information on "The 60th General Meeting of the Quality Committee" is now available.
-
Intellectual Property Committee
The following pages are released: "IP PACT: (IP Principles for Advancing Cures and Therapies).
-
Announcements
Newspaper Advertisement" is now available.
-
Drug Evaluation Committee
Guidance for Preparation of Drug Risk Management Plan (J-RMP) - April 2021 Edition" is now available.
-
Announcements
Information on "Cancellation of the Press Conference after the 60th General Meeting of the Quality Committee" is now available.
-
Announcements
The following pages are released: "The 10th Conference of Asian Pharmaceutical Manufacturers and Associations" (Japanese only).
-
Quality Committee
Information on "The 60th Press Conference after the General Meeting of the Quality Committee" is now available.
-
Announcements
Notice of Cancellation of "The 544th Press Conference after the Board of Directors Meeting of the Pharmaceutical Affairs Association of Japan" is posted.
-
Regulatory Affairs Committee
Information on "The 33rd Press Conference after the General Meeting of the Pharmaceutical Affairs Committee" is now available.
-
Drug Evaluation Committee
Information on "The 137th Press Conference after the General Meeting of the Drug Evaluation Committee" is now available.
-
Announcements
Information on "The 544th Pharmaceutical Manufacturers Association of Japan (PMAJ) Press Conference" is now available.
-
Announcements
Information on "Pharmaceutical Association of Japan Media Forum" is now available.
-
Announcements
Business Policy, Business Plan, and Implementation Plan" for FY2021 is now available.
-
Announcements
DATA BOOK 2021 English version" is now available.
-
Announcements
DATA BOOK 2021 English Version" was released.
-
Announcements
Q&A received on Clinical Trial 119 after February 8, 2021" is now available.
-
Announcements
The material of "Press Conference of the President of the Pharmaceutical Manufacturers Association of Japan" is now available.
-
Announcements
Symposium on Causal Inference for Understanding ICH-E9(R1)" (March 2021) is now available.
-
Announcements
Information on "The 10th Asian Pharmaceutical Association Conference "APAC"" is now available.
-
Drug Evaluation Committee
The "Explanation of Revision of Notification on Reexamination, Periodic Safety Reporting and Conformity Assessment in FY2020" (March 2021) is now available.
-
Announcements
Video clips of "The 32nd JPSPMA Policy Seminar" are now available.
-
Announcements
Information on "Pharmaceutical Association of Japan Media Event" is now available.
-
Announcements
Policy Proposal 2021" (March 2021) is now available.
-
Announcements
DATA BOOK 2021 Japanese" has been released.
-
Announcements
Pharmaceutical Manufacturers Association of Japan Newsletter No. 202" has been released.
-
Announcements
Information on "The 259th Pharmaceutical Association of Japan Press Conference" is now available.
-
Announcements
Global Health "Current Status and Initiatives around the World" has been updated.
-
Announcements
Universal Health Coverage" in Global Health has been updated.
-
Announcements
Global Health Issues (Infographics)" by Global Health has been updated.
-
Announcements
The video of "The New Medical and Pharmaceutical Industry Dream Meditemple 2021 Special "No.4: Frail and Osteoporosis" is now available.
-
Announcements
IFPMA's "#Team Vaccines" campaign video is now available.
-
Announcements
Information program "From Iwate! Oraho's Health Protected by Medicines: Ten Years after the Earthquake and Countermeasures for Infectious Diseases" video is now available.
-
Announcements
IFPMA's #Team Vaccines website is now available.
-
Announcements
Videos of the information program "Iwate Prefecture!
-
Announcements
IFPMA's "Vaccines Confidence Digital Campaign" is now available.
-
Drug Evaluation Committee
Study on Data De-identification Methodology for Clinical Trial Data Sharing (CTDS)" is now available.
-
Code Compliance Promotion Committee
Summary of Results of Questionnaire Follow-up Survey on GL for Marketing Information Provision Activities (conducted in November 2020)" has been released.
-
Announcements
Videos of "Susumu Iryashin-Yume no Medi-Temple 2021 Special "Part 2: Viral Infectious Diseases and Humanity" are now available.
-
Announcements
The 5th edition of "Drugs and Clinical Trials" is now available.
-
Announcements
Two Q&A received in Clinical Trial 119 after December 29, 2020" is posted.
-
Drug Evaluation Committee
CDISC and Electronic Data Submission Documents Resource Collection (4th Edition) (February 2021)" is posted.
-
Announcements
Information on "Press Conference after the 553rd Pharmaceutical Association of Japan Board of Directors Meeting" is now available.
-
Announcements
Notice of Publication of "Guidance for Creating XML Files for Notification of Clinical Trials (4th Edition)" is posted.
-
Drug Evaluation Committee
Workshop for Practitioners on Electronic Data Submission at the Time of Application" (February 2021) has been posted.
-
Announcements
The movie "Medical and New Drugs: Dream of Medi-Temple 2021 Special "Part 1: Novel Coronavirus Infections" is now available.
-
Biopharmaceutical Committee
The "Precautions for Conducting Clinical Trials of Gene Therapy Products and Recombinant Live Vaccines for the Prevention of Infectious Diseases (Version 2)" is now available.
-
Announcements
<Information on "The 258th Annual Meeting of the Pharmaceutical Manufacturers Association of Japan (PMAJ)" is now available.
-
Announcements
The "National Center Biobank Network and JCIA Member Companies Launch Industry-Academia-Government Collaboration to Establish and Utilize Integrated Database of Disease-Specific Information - Toward Early Implementation of Precision Medicine, Preventive Medicine, and Preemptive Medicine" is now available.
-
Announcements
Pharmaceutical Manufacturers Association Newsletter No. 201" is now available.
-
Announcements
3 Q&A received in Clinical Trial 119 after November 26, 2020 have been posted.
-
Announcements
Information on "The 258th Pharmaceutical Manufacturers Association of Japan (PMAJ) Press Conference" is now available.
-
Announcements
The article "Measures to prevent new coronavirus infection - Following the declaration of a state of emergency -" is now available.
-
Industry Policy Committee
Appropriate Use of Drugs" was updated.
