2021 Update Information

The 39th Patient Group Seminar (Online) Video Streaming" (Japanese only) 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 "Guideline Workshops on Technical and Regulatory Approaches to Life Cycle Management of Pharmaceuticals" 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 Assembly of the Drug Evaluation Committee" is 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.

JPMA Newsletter No.206" has been released.

Guidance for 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' Opinions" Symposium for Pharmaceutical Companies.

JPMA Code of Practice "Month to Promote Understanding of the JPMA Code of Practice"" is now available.

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" is posted.

Clinical Trial 119: Q&A update: "Necessity of Investigational Review Committee Review of Changes to Clinical Trial Protocol after Clinical Trial Completion

Clinical Trial 119: Q&A update: "Review by the Clinical Trial Review Committee on the Deletion of a Clinical Research Assistant" (Japanese)

JPMA member company's "Non-Financial Information Disclosure List" (links) is newly added.

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 posted.

Information on "ICH Quality Forum" is now available.

Disciplinary Action against a Member Company" is posted.

Event related to WHO Western Pacific Regional Committee" is now available.

JPMA Newsletter No. 205" is now available.

The "Pharmaceutical Industry Vision 2021" is released.

Guideline Workshops on "ICH Q13: Draft Guideline for Continuous Manufacturing of Drug Substances and Drug Products" reached in Step 2" is now available.

Briefing on ICH S5 and S11" is now available.

JPMA website 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.

JPMA 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).

The "Guideline Workshops on the Draft Guideline "Nonclinical Biodistribution Considerations for Gene Therapy Products" Reaching ICH S12: Step 2" was posted.

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 Workshops" has been updated.

Public Meetings" has been updated.

JPMA 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.

JPMA Guide 2021" is now available.

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

JPMA Chairman's Press Conference on May 20" is available.

New Directors Election" is available.

JPMA Industry Vision 2025 Supplement" is now available.

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.

JPMA 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 posted.

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 JPMA Presidents" is now available.

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

Explanation of Revisions to Notification Concerning Reexamination, Periodic Safety Reporting, and Conformity Surveillance in FY2020" (March 2021) is now available.

JPMA Policy Proposal 2021" is now available.

DATA BOOK 2021 Japanese" has been released.

JPMA Newsletter No. 202" has been released.

Global Health Issues" in Global Health 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)" is now available.

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

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

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

Notice of Publication of "Guide to Creating XML Files for Notification of Clinical Trials (4th Edition)" is now available.

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

The "National Center Biobank Network and Japan Pharmaceutical Manufacturers Association 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.

JPMA Newsletter No. 201" is now available.

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

The following pages are released: "Measures against new coronavirus infection - Following the declaration of a state of emergency -" is posted.

The following pages are released / updated: "Proper Use of Medicines" (Japanese only)