Regulation

ISSCR’s regulatory affairs helps members navigate the international regulatory landscape and facilitates the development of stem cell-based interventions and other applications (from tissue transplants to drug screening). We provide input via meetings and written comments on behalf of our members to the U.S. Food and Drug Administration, the European Medicines Agency, the U.K. Medical and Healthcare products Regulatory Agency, and other regulators about scientific findings and considerations that will help regulators make scientifically informed recommendations for the advancement of stem cell therapies.

ISSCR regulatory affairs is led by the Committee on Manufacturing, Clinical Translation, and Regulation. You may contact this committee here.