Drug Evaluation Committee Guidance for Preparation of "Post-Marketing Surveillance Implementation Plan" and "Post-Marketing Surveillance Implementation Report" (Revised 2022)
December 2022
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 after 2020 due to the Corona Disaster, the following amendment was made on May 31, 2022 to reflect the actual implementation method. 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) on May 31, 2022. In accordance with this, we have decided to update the contents of the current Green Book and publish it as "Guidance for Preparation of "Postmarketing Surveillance Implementation Plan" and "Postmarketing Surveillance Implementation Report" (revised edition of 2022)".
We hope that it will be of help to those who are engaged in related work in the execution of their duties.
Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association