As cellular therapy products often cross international borders, it is important to be aware of applicable regulations in other regions. Products shipped across international borders must meet regulatory requirements of the competent authority of the exporting and importing country. Information on some non-U.S. competent authorities can be accessed via the links provided below. The information for each country is meant to serve as a resource, not a substitute for regulatory information or legal advice. Additionally, the information on this page is not updated in real-time, please contact the relevant competent authority to receive the most up-to-date information.
REGULATORY UPDATE: FDA Issues Draft Guidance to Support CGT Development
November 19, 2024
AABB Accepting Feedback on Cell and Gene Therapy Standards for Pharmacy
November 19, 2024
FDA Approves Direct-to-Brain Gene Therapy for AADC Deficiency
November 14, 2024