Drug Evaluation Committee Briefing on the Amendment of the Pharmaceuticals and Medical Devices Act (related to Notification of Clinical Trials and Reporting of Adverse Effects of Clinical Trials)
Clinical Evaluation Subcommittee
We are pleased to inform you that we have posted the materials of the explanatory meeting on the revision of the Pharmaceuticals and Medical Devices Act (related to notification of clinical trial and reporting of adverse drug reactions) held on June 8, 2021.
This briefing was held jointly by the Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA), and focused on the newly defined "investigational new drug" and its application in accordance with related notifications, etc., from the viewpoints of both administrative authorities and pharmaceutical companies, with regard to the revision of the system for notification of clinical trial and reporting of adverse drug reactions that came into effect on September 1, 2020, Explanation was given on the key points of the amendment of the law regarding notification of clinical trial and reporting of adverse drug reactions, etc., based on examples. We hope that this briefing will help you to respond to the amendment of the law.