Drug Evaluation Committee Briefing on the Revised Pharmaceuticals and Medical Devices Act -Impact of the Introduction of Investigational New Drugs on Clinical Trials-" held on February 22, 2022
Clinical Evaluation Subcommittee
The materials for the "Information Meeting on the Revised Pharmaceuticals and Medical Devices Act -Impact of the Introduction of Investigational New Drugs on Clinical Trials-" held on February 22, 2022 are now available (the recording will be available only until the end of March, 2022).
This briefing session will focus on the handling of "investigational new drugs" newly defined in the "Act for Partial Revision of the Act on Quality, Efficacy and Safety Assurance of Pharmaceuticals, Medical Devices and Other Related Matters" (Act No. 63 of 2022), which was promulgated on December 4, 2019, in order to ensure efficient and effective transition of the system. Explanation will be given to Investigator Sites and SMOs, as well as pharmaceutical companies, CROs, system vendors, etc., on the key points of the amendment and the impact of the amendment, including management of investigational new drugs at Investigator Sites and handling of issues that may arise during the transition from the old system to the new system.
We hope that this presentation will help you to cope with the transition to the new system.