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.
ISSCR Joins Coalition Effort to Support Advocacy for NIH Funding
The ISSCR is proud to join a broad coalition of scientific societies in affirming the essential role of the National Institutes of Health in advancing biomedical discovery and sustaining a robust research enterprise. As part of this effort, ISSCR members in the targeted states of Kansas, North Carolina, Pennsylvania, and Utah have been invited to share stories that illustrate the vital importance of research investment. Additional opportunities for members in all states will be available in September. This campaign is led by our alliance partner, Research!America.
The ISSCR Calls for Science Serving the Public Good to be of the Highest Quality and Integrity
“The ISSCR joined more than 90 scientific, academic, and professional organizations to emphasize that science serving the public good should be of the highest quality, integrity, and utility. In a letter sent to White House Office of Science and Technology Policy Director Michael Kratsios, signatories urged policymakers to recognize that any efforts to strengthen scientific integrity, including those outlined in the recent Executive Order “Restoring Gold Standard Science”, must build upon, rather than undermine, the existing foundational pillars of gold standard science that have driven decades of scientific and technological progress. These principles, including empirical rigor, objectivity, peer review, and reproducibility have been central to the advancement of stem cell science and the development of cell-based therapies.
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.
Receive ISSCR Press Releases
Sign up be a part of ISSCR’s media list. Media Contact: Kym Kilbourne, Director of Media and Strategic Communications
Subscribe to ISSCR News.
Each month, ISSCR delivers scientific, policy, and community to your inbox .