The ISSCR Holds Inaugural Regulatory Meeting with Japan’s Pharmaceuticals and Medical Devices Agency and South Korea’s Ministry of Food and Drug Safety

On 7 November 2024, the International Society for Stem Cell Research (ISSCR) held its first meeting with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and Korea’s Ministry of Food and Drug Safety (MFDS). Held at PMDA’s Tokyo headquarters, the meeting brought together senior officials from PMDA and MFDS alongside ISSCR leaders based in Japan, Korea, and the United States.

At this inaugural meeting, participants convened to discuss key topics related to the 1) manufacture of human Pluripotent Stem Cell (hPSC) banks as starting materials for allogeneic, PSC-based therapies, 2) genetic assessment of hPSCs, 3) jurisdictional differences in guidelines for biological Ancillary Materials (AM). The participants also had the opportunity to gain insights into the regulatory approaches of the PMDA and MFDS regarding PSC-based products.

Read the meeting summary. View the MFDS Cell & Gene Therapy Products Guidelines. Read the full press release.