Regulation

The ISSCR helps members navigate the regulatory landscape and facilitates the development of stem cell-based interventions and other applications (from tissue transplants to drug screening). The society shares input about scientific findings and considerations to help global regulators make scientifically informed recommendations for the development of stem cell therapies.

Recent Activity

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The ISSCR Provides Comments on FDA’s Draft Guidance for Potency Assurance for Cellular and Gene Therapy Products 
Facilitating Scientifically Informed Regulatory Decision-Making
The ISSCR Provides Comments on FDA’s Draft Guidance for Potency Assurance for Cellular and Gene Therapy Products 
Facilitating Scientifically Informed Regulatory Decision-Making

On 5 March 2023, the ISSCR submitted comments on the Food and Drug Administration’s draft guidance for Potency Assurance for Cellular and Gene Therapy (CGT) Products. ISSCR appreciates FDA’s commitment to assuring the potency of human CGT products at all stages of the product lifecycle. This guidance from the FDA will help our members, who are at the forefront of research and innovation, in their work.

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Facilitating Scientifically Informed Regulatory Decision-Making
The ISSCR Provides Comments on FDA’s Draft Guidance for Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products
Facilitating Scientifically Informed Regulatory Decision-Making
The ISSCR Provides Comments on FDA’s Draft Guidance for Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products
Facilitating Scientifically Informed Regulatory Decision-Making
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Facilitating Scientifically Informed Regulatory Decision-Making
The ISSCR Provides Comments on FNIH’s Accelerating Medicines Partnership Cell-Based Therapy Initiative
Facilitating Scientifically Informed Regulatory Decision-Making
The ISSCR Provides Comments on FNIH’s Accelerating Medicines Partnership Cell-Based Therapy Initiative
Facilitating Scientifically Informed Regulatory Decision-Making

On 25 September 2023, the ISSCR submitted comments in response to the Foundation for National Institutes of Health’s (FNIH) Request for Information on Cell-Based Therapies for use in developing an Accelerating Medicines Partnership (AMP) Cell-Based Therapy Consortium.

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Facilitating Scientifically Informed Regulatory Decision-Making

Position

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.