Drug Evaluation Committee Explanation of the Amendments to the Notification Concerning Re-Examination, Periodic Safety Reporting and Conformity Assessment for FY2020 (March 2021) (March 2021)
March 2021
Based on the "streamlining of reexamination application materials" in the "Regulatory Reform Implementation Plan" approved by the Cabinet on June 15, 2008, the "Materials to be attached to applications for reexamination of new ethical drugs" was partially revised (March 25, 2020, Pharmaceutical and Pharmaceutical Affairs Ministry Notification No. 0325-10) and the "New Pharmaceutical Affairs Law Enforcement Regulations, etc., were revised (August 31, 2020). Partial amendments were made to the "Periodic Safety Reporting System for New Ethical Drugs" (NHI Drugs Hearing No. 0831, August 31, 2020) in accordance with the revision of the Ordinance for Enforcement of the Pharmaceutical Affairs Act (August 31, 2020), and the "Implementation Guidelines for Written Investigation of Conformity of Application Materials for Approval of New Drugs, GCP On-Site Surveillance of Drugs, and GPSP On-Site Surveillance of Drugs" (NHI Drug Substance Evaluation Agency No. 0831, August 31, 2020). The PV Subcommittee's Continuing Issues Response Team 3 has prepared this document to provide an overall understanding and organization of the revisions so that practitioners can better check and understand the contents, and to ensure that important changes are addressed without omission.
This document is designed to help practitioners better understand the overall content of the revisions and to ensure that important changes are addressed.
We hope that this document will be of use to our members in their reexamination work.
Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association
Pharmacovigilance Subcommittee Continuing Issues Team 3