A Comparative Study of Regulations of Cell and Gene Therapy in the US, EU, and India
December 2022
in “
International journal of drug regulatory affairs
”
TLDR The US and EU lead in cell and gene therapy regulations with more approvals and clinical trials, while India is in early stages with fewer approvals and expedited processes.
The study compares the regulations of cell and gene therapy products (CGTs) in the United States, European Union, and India. The US and EU are leading in the development of these therapies, with India in its early stages. The regulatory framework for CGTs falls under biological products in all three regions. The US has approved 20 CGTs, with 7 gene therapy medicinal products (GTMPs) and 13 cell therapy medicinal products (CTMPs). There are 355 clinical trials for advanced therapy medicinal products (ATMPs) in the US, with 225 GTMPs, 105 SCTMPs, and 25 CATMPs. In India, there are two procedures to expedite drug approval: Conditional Approval and Fast Track Approval. Only four products have been approved in India: Apceden, Stempeucel, Ossgrow, and Cartigrow. The study also notes an increase in unproven stem cell clinics in the US, highlighting the need for further research and regulatory oversight.
