ISCT provided comments for WHO Considerations on Regulatory Convergence of Cell and Gene Therapy Products
Closed 24 January 2022
ISCT Regulatory Committees (ANZ LRA, EU LRA, NA LRA, SCA LRA, GRTF), Committee on the Ethics of Cell and Gene Therapy, and the Lab Practices Committee submitted formal comments for "WHO Considerations on Regulatory Convergence of Cell and Gene Therapy Products"
This whitepaper describes current WHO’s thinking on considerations for regulation of Cell and Gene Therapy Products (CGTPs), to promote convergence, and encourage the Member States to strengthen their regulatory system on Cell and Gene Therapy Products regulation. The whitepaper outlines the fundamental principles that are important for providing adequate regulatory oversight for different types of CGTPs and should be reviewed in that context. In the future, WHO plans to develop more comprehensive written guidance, as needed, on specific topics relevant to the regulation of CGTPs.