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.
FDA Seeks Comment on BPD, HCT/P Deviation Reporting
February 25, 2026
FDA Issues Draft Guidance Establishing Framework for Individualized Gene Therapies
February 25, 2026
Japanese Regulatory Panel Recommends Advancing World’s First iPSC-Based Therapies
February 24, 2026