ISSCR News
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, and
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.
The ISSCR Responds to ICH’s Q1 Guideline on Stability Testing of Drug Substances and Drug Products
On 28 July, the ISSCR submitted a response to the International Council for Harmonisation’s (ICH) guideline on stability testing of drug substances and drug products. The ISSCR recommends adding specific examples to clarify appropriate applications of certain studies and incorporating considerations for diverse manufacturing models, particularly decentralized manufacturing, where products are administered immediately after production. The ISSCR also advises including guidance on pluripotent stem cell bank stability testing, referencing Tissue Engineered Products (TEP), and clarifying whether ATMP combined products are covered under the term “combination of a drug product with a medical device.”
To request the comments or learn more, contact Denise de Villa.
The ISSCR Responds to EMA’s Concept Paper on the Revision of Part IV Guidelines on GMP Specific to ATMPs
On 8 July 2025, the ISSCR submitted comments on the European Medicines Agency's concept paper on the revision of Part IV Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products. ISSCR supports the proposal to update t Part IV of the Guidelines to address inconsistencies, clarify ambiguities, and to include guidance on the use of new manufacturing technologies.
The ISSCR recommends incorporating these updates into the main body of EudraLex Volume 4, rather than maintaining them as a separate document. This approach would offer more consistent and clear guidance to ATMP developers.
To request the comments or learn more, contact Denise de Villa.
The ISSCR Responds to FDA’s Draft Guidance on Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products
On 29 July 2024, the ISSCR submitted comments on the Food and Drug Administration’s draft guidance for Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products. ISSCR supports FDA’s desire to share their recommendations for determining the appropriate cell safety testing and offers comments to complement FDA's initiative. Specifically, ISSCR requests clarification on genomic testing requirements and proposes adjustments to the guidance on sequencing depth and cytogenetic testing. Additionally, ISSCR recommends using both sequencing and cytogenetic testing to ensure comprehensive safety assessments.
ISSCR Holds First Academia Briefing Meeting with the European Medicines Agency
On 10 April 2024, the ISSCR held its first Academia Briefing Meeting with the European Medicines Agency (EMA). The meeting was organized by ISSCR’s Manufacturing, Clinical Translation, and Regulatory (MCTR) Committee and included invitees to present to the agency on two topics: recommendations for the manufacturing of PSC banks as starting materials for allogeneic PSC-based therapies and genetic characterization of human PSCs. Following the meeting, both parties confirmed the importance of regular meetings to ensure a bi-directional sharing of knowledge to advance the development of cellular therapies.
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