Drug Evaluation Committee Explanation of "Procedural Guidance for Lifting Conditions of Approval for Post-Marketing Surveillance, etc. / Q&A on Use-results Surveillance of Ethical Drugs by the All-Patient Surveillance Method
Pharmacovigilance Subcommittee
October 2024
The provisions related to conditions of approval are stipulated in Article 79 (Conditions of Approval, etc.) of the Act on Quality, Efficacy and Safety Assurance of Pharmaceuticals and Medical Devices, etc. For pharmaceutical products for which information on safety, etc. is particularly limited at the development stage or for which it is particularly necessary to ensure safety after approval, conditions of approval are attached before approval is granted. The conditions of approval include an all-patient surveillance. However, once the target number of cases has been reached and a certain level of analysis and evaluation is possible, the condition can be lifted without waiting for a reexamination application.
The "Q&As on Investigations of Usage Results of Ethical Drugs Based on the All-Patient Surveillance Method" (August 8, 2048, Ministry of Health, Labour and Welfare, Pharmaceuticals and Welfare Bureau, Drug Evaluation and Management Division, Office Communication) provides information on how to conduct all-patient surveillance, etc. (August 10, 2023, Ministry of Health, Labour and Welfare, Pharmaceuticals and Welfare Bureau, Drug Evaluation and Control Division, Office Communication), Q&A5 and Q&A6 have been revised. In addition, Q&A5 and Q&A6 were revised by the "Partial Revision of 'How to Proceed with the Examination of the Formulation of Implementation Plans for Post-Marketing Surveillance of Pharmaceuticals'" (Pharmaceutical and Pharmaceutical Safety Bureau, Ministry of Health, Labour and Welfare, joint notification of July 18, 2024, No. 0718-1 by the Director of Drug Evaluation and Management Division and Director of Drug Safety Measures Division) and the "Partial Revision of 'Guidelines for the Examination of the Formulation of Implementation Plans for Post-Marketing Surveillance of (July 18, 2024, Ministry of Health, Labour and Welfare, Pharmaceuticals Bureau, Pharmaceuticals Evaluation and Management Division, Ministry of Health, Labour and Welfare), and "Partial Revision of Q&A on Investigation of Usage Results of Ethical Drugs Based on the All Patient Survey Method" (July 18, 2024, Office Communication, Drug Evaluation and Management Division, Pharmaceuticals Bureau, Ministry of Health, Labour and Welfare), Q&A1 was revised and Q&A1-1 was newly established.
Based on the above background, we have decided to publish this document. We hope that this document will be of assistance to all companies involved in post-marketing surveillance operations.
Prepared in October 2024 (ver. 2.0)
Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association
PV Subcommittee Continuing Issues Team 3