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.
Cell Notes: What FDA’s Regulatory Flexibility Means for the Future of Cell and Gene Therapy
January 27, 2026
FDA Announces More Flexible Approach to CGT Regulation
January 13, 2026
REGULATORY UPDATE: FDA Releases 2026 CBER Guidance Agenda
January 12, 2026