Drug Evaluation Committee Guidance for Preparation of "Post-marketing Surveillance Implementation Plan" and "Post-marketing Surveillance Implementation Report" (revised edition of 2024)
Pharmacovigilance Subcommittee
March 2024
In principle, MRs visit medical institutions in person to conduct various activities related to post-marketing surveillance. However, due to the recent development of digital technology and the introduction of online interviews, etc. after 2020 due to the Corona Disaster, a new guideline was established to reflect the actual implementation method, dated May 31, 2022, in the Pharmaceutical Affairs Bureau of the Ministry of Health, Labour and Welfare (MHLW). In order to reflect the actual implementation method, a notice entitled "Methods of Conducting Post-Marketing Surveillance of Ethical Drugs" and an administrative communication entitled "Q&A on Post-Marketing Surveillance of Ethical Drugs" were issued by the Director, Pharmaceutical Safety Measures Division, Pharmaceuticals and Life Sanitation Bureau, Ministry of Health, Labour and Welfare (MHLW), dated May 31, 2022. In December 2022, the Ministry of Health, Labour and Welfare issued the "Guidance for Preparation of the "Postmarketing Surveillance Implementation Plan" and "Postmarketing Surveillance Implementation Report" (revised edition of 2022)," updating the contents of the Green Book.
Subsequently, in accordance with the "Procedures for Online Submission Using the Application Electronic Data System" notified by the Drug and Medical Devices Agency (Safety Information and Planning Administration Department, etc.) on August 30, 2023, the latest edition of the Green Book, "Guidance for Preparation of 'Post-Marketing Surveillance Implementation Plan' and 'Post-Marketing Surveillance Implementation Report' (revised 2022)," which adds a new method of report submission, was published in December 2022. The "Guide for Preparation of "Post-Marketing Surveillance Implementation Plan" and "Post-Marketing Surveillance Implementation Report" (revised edition of 2024)" is published to provide guidance on how to submit the reports.
We hope it will be of help to those who are engaged in related work.
Issued in March 2024
Committee on Drug Evaluation, Japan Pharmaceutical Manufacturers Association
Pharmacovigilance Subcommittee Continuing Issues Response Team 8
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