On July 26, the PMDA held the “PMDA-ATC Regenerative Medical Products FIH Webinar 2023 for NPRA, Malaysia”. The theme of the webinar was first-in-human (FIH) studies of regenerative medical products. The PMDA staff members from the Office of Cellular and Tissue-based Products shared information on the Japanese regulatory system and PMDA’s experiences with 23 National Pharmaceutical Regulatory Agency (NPRA) regulators engaging in the review of biologics, and so on. The PMDA continues to provide training opportunities and contributes to the capacity building of the NPRA.
See attached program