Drug Evaluation Committee Briefing on the Revised Pharmaceuticals and Medical Devices Act -Responses, etc. required of pharmaceutical companies based on notifications and examples-", held on February 22, 2022
Clinical Evaluation Subcommittee
The materials for the "Information Meeting on the Revised Pharmaceuticals and Medical Devices Act - Responses Required of Pharmaceutical Companies Based on Notices and Cases -", to be held on February 22, 2022, are now available.
This briefing session is intended for pharmaceutical companies, CROs, system vendors, etc., to provide information on specific examples of drugs used in clinical trials and devices equivalent to those used in clinical trials, as well as the measures required of pharmaceutical companies in light of the new notifications issued since the June 8, 2021 "Information Meeting on the Revised Pharmaceuticals and Medical Devices Act (related to notification of clinical trials and reporting of adverse reactions, etc.)," and to ensure efficient and effective transition to the new system. Explanation will be given on the specific examples of drugs used in clinical trials and devices used in clinical trials, points to keep in mind when notifying clinical trials and reporting adverse reactions, points to keep in mind in related notifications, and measures required of pharmaceutical companies in the transition to the new system.
We hope this briefing will be of some help in dealing with the transition to the new system.