ISSCR News
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 Signals Concerns About Dangerous and Devastating Cuts to HHS in President Trump’s Draft FY 2026 Budget
The ISSCR joined with more than 500 health and research coalitions and organizations to express concern regarding the Administration’s draft (now proposed) Fiscal Year 2026 budget for the U.S. Department of Health and Human Services (HHS) that proposes a nearly 40% cut to the National Institutes of Health.
In a letter sent to the Chairs and Ranking Members of the Senate and House Appropriations Subcommittees for Labor, Health and Human Services, and Related Agencies, signatories stressed that the proposed FY 2026 budget would cut about one-third of the agency’s discretionary spending and effectively devastate the nation’s research, scientific, and public health infrastructure. Characterized as dangerous and devastating, the budget proposal would put the nation’s health and security at risk.
ISSCR Statement on the Scientific and Therapeutic Value of Human Embryonic Stem Cell Research
Human embryonic stem (hES) cells represent a foundational platform in stem cell science. Their capacity for sustained self-renewal and pluripotency—the ability to differentiate into all cell types in the body—enables critical research into human development, disease mechanisms, and the development of new regenerative medicines.
The ISSCR Signs on to Coalition Letter in Support of NIH
The ISSCR joined with Research!America, hundreds of biomedical research organizations, and thousands of private citizens from the U.S. scientific community to urge House and Senate appropriators to avoid a full-year continuing resolution for Fiscal Year 2025 appropriations and instead provide a robust funding increase for the National Institutes of Health (NIH). The letter also calls for the preservation of existing protections against cuts to reimbursement for NIH grantee Facilities and Administrative costs. These drastic cuts will slow scientific progress and weaken the U.S. research ecosystem.
The ISSCR Encourages Japanese Policymakers to Increase Oversight of Regenerative Medicine Interventions
Today, the ISSCR sent a letter to Japan’s Ministry of Health, Labour, and Welfare encouraging the Ministry to implement regulations that adhere as closely as possible to international guidelines for the administration of regenerative medicine interventions.
In the letter, shared in response to amendments to the Act on the Safety of Regenerative Medicine (ASRM), the ISSCR commends Japan for taking steps to strengthen the ASRM to protect patient safety and offers recommendations citing this opportunity to strengthen Japan’s approach to regenerative medicine oversight.
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