2021 Update Information

The 39th Patient Group Seminar (held online) video streaming" is now available.

The 39th Patient Group Seminar (Online) Video Streaming" is now available.

The "Fiscal 2022 Reform of the NHI Drug Price System" is now available.

Newly added "Related Information on New Coronavirus Infections" (Japanese)

The 44th ICH Immediate Report Meeting (Web-based)" is now available.

A report on "Survey on Public Awareness of AMR and Antimicrobial Drug Development" is now available.

The "Guidance for Conformity Assessment" (November 2021) is now available.

The Asahi Shimbun Company "Oshigoto Nenkan 2021" has been added.

ICH Q12 "Guidelines for Technical and Regulatory Approaches to Life Cycle Management of Pharmaceuticals" Briefing Session" is now available.

The following pages are released: "Introduction and Modeling of NICE TSD - Collection and Review of Evidence for Modeling -" (Japanese only)

The 139th General Meeting of the Committee on Drug Evaluation" materials are now available.

The "9th Taiwan-Japan Pharmaceutical Exchange Conference" is now available.

The 15th Survey on Sei-katsu-sha Attitudes Toward Drugs and the Pharmaceutical Industry

The 15th Survey on Sei-katsu-sha Attitudes Toward Drugs and the Pharmaceutical Industry" is now available.

The "Pharmaceutical Manufacturers Association of Japan Newsletter No.206" is now available.

The "Guide to Application for Reexamination" 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 2021 Survey -" is now available.

Publication of "Drug Development Based on Patients' Voices" Symposium for Pharmaceutical Companies.

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

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).

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.

Clinical Trial 119: Q&A update: "Review by the Clinical Trial Review Committee on the deletion of a subinvestigator" (Japanese)

Clinical Trial 119: Q&A update: "Obtaining consent on or after April 1, 2022

Guidance for Periodic Safety Reporting" is now available.

Newspaper Advertisement" is now available.

Information on "ICH Quality Forum" is available.

Disciplinary Action against a Member Company" is posted.

Holding of "Event related to WHO Western Pacific Regional Committee

ICH Newsletter No. 205" is now available.

Following the release of the "Pharmaceutical Industry Vision 2021

Information on "ICH Q13: Draft Guideline for the Continuous Production of Active Pharmaceutical Ingredients and Dosage Forms (Draft Guideline)" is now available.

ICH S5/S11 Briefing Session" is now available.

The website of the Pharmaceutical Manufacturers Association of Japan (PMAJ) has been renewed.

Manual for Notification of Electronic Drug Information for Prescription Drugs (August 2021 version)" is now available.

Japanese Translation of FDA Guidance on Adaptive Design" is now available.

The "Pharmaceutical Manufacturers Association Guide 2021 English/Chinese version" is now available.

AMR Action Fund Japanese website is now available.

IFPMA's Vaccines Confidence Digital Campaign" is updated.

3 Q&A received in Clinical Trial 119 after July 19, 2021" is now available.

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).

Briefing session on "ICH S12: Draft Guideline for Reaching Step 2: Concept of Non-clinical Biodistribution Studies of Gene Therapy Products" is now available.

Q&A on 3 Q&A received in Clinical Trial 119 on or after March 22, 2021" is posted.

Disciplinary Action against a Member Company" is posted.

Starting Today! Process Management of Clinical Trials at Medical Institutions" has been added.

Guideline Briefing Session" has been updated.

List of Immediate Debriefing Sessions" has been updated.

Pharmaceutical Manufacturers Association Newsletter No. 204" is now available.

MA Subcommittee TF3 Deliverable "Q&A on the Implementation of Medical Education Meeting and Medical Booth" is now available.

The deliverable "Serial Production Project Deliverables" has been released.

The "Pharmaceutical Risk Management Plan (RMP): Considerations for Evaluating the Effectiveness of Additional Risk Minimization Activities (Materials)" is now available.

Guidance for Preparation of Defect Reports Related to Drug Substance Combination Products (2021 Edition)" is now available.

"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.

YouTube Video: Innovative Changes in Data Management" is now available.

Event Report "JPMA/PhRMA/EFPIA Joint Press Conference" is now available.

The "Pharmaceutical Manufacturers Association Guide 2021" is now available.

Study Design and Statistical Evaluation Methods for Development of Regenerative Medicine Products" is now available.

The "EFPIA Chairman's Press Conference on May 20" is now available.

New Directors Election" is available.

The following pages are released / "The Pharmaceutical Association of Japan Industry Vision 2025 Supplementary Edition" is posted on the website.

Updated "Message from the Chairman" and "Board of Directors".

Guidance for Providing Information on "Electronic Drug Information Sheet for Prescription Drugs"-May 2021 Edition-is now available.

Pharmaceutical Manufacturers Association of Japan Newsletter No. 203" is now available.

WTO Waiver of Intellectual Property Rights" is now available.

Analysis of Application Materials for Regenerative Medicine Product Approval (Life Cycle Management Information)" is available.

（New Drug Development Using Real World Data and Disease Registries" is added.

Innovative Changes in Data Management (Full Version)" is now available.

The following pages are released: "IP PACT: (IP Principles for Advancing Cures and Therapies).

Newspaper Advertisement" is now available.

Guidance for Preparation of Drug Risk Management Plan (J-RMP) - April 2021 Edition" is now available.

The following pages are released: "The 10th Conference of Asian Pharmaceutical Manufacturers and Associations" (Japanese only).

Business Policy, Business Plan, and Implementation Plan" for FY2021 is now available.

DATA BOOK 2021 English version" is now available.

DATA BOOK 2021 English Version" was released.

Q&A received on Clinical Trial 119 after February 8, 2021" is now available.

The material of "Press Conference of the President of the Pharmaceutical Manufacturers Association of Japan" is now available.

Symposium on Causal Inference for Understanding ICH-E9(R1)" (March 2021) is now available.

The "Explanation of Revision of Notification on Reexamination, Periodic Safety Reporting and Conformity Assessment in FY2020" (March 2021) is now available.

Policy Proposal 2021" (March 2021) is now available.

DATA BOOK 2021 Japanese" has been released.

Pharmaceutical Manufacturers Association of Japan Newsletter No. 202" has been released.

Global Health "Current Status and Initiatives around the World" has been updated.

Universal Health Coverage" in Global Health has been updated.

Global Health Issues (Infographics)" by Global Health has been updated.

IFPMA's "#Team Vaccines" campaign video is now available.

IFPMA's #Team Vaccines website is now available.

IFPMA's "Vaccines Confidence Digital Campaign" is now available.

Study on Data De-identification Methodology for Clinical Trial Data Sharing (CTDS)" is now available.

Summary of Results of Questionnaire Follow-up Survey on GL for Marketing Information Provision Activities (conducted in November 2020)" has been released.

The 5th edition of "Drugs and Clinical Trials" is now available.

Two Q&A received in Clinical Trial 119 after December 29, 2020" is posted.

CDISC and Electronic Data Submission Documents Resource Collection (4th Edition) (February 2021)" is posted.

Notice of Publication of "Guidance for Creating XML Files for Notification of Clinical Trials (4th Edition)" is posted.

Workshop for Practitioners on Electronic Data Submission at the Time of Application" (February 2021) has been posted.

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.

Pharmaceutical Manufacturers Association Newsletter No. 201" is now available.

3 Q&A received in Clinical Trial 119 after November 26, 2020 have been posted.

The article "Measures to prevent new coronavirus infection - Following the declaration of a state of emergency -" is now available.

Appropriate Use of Drugs" was updated.