Regenerative medicine regulatory policies: A systematic review and international comparison

A small number of regenerative medicines (RMs) have received market authorization (MA) worldwide, relative to the large number of clinical trials currently being conducted. Regulatory issues constitute one major challenge for the MA of RMs. This study aimed to systematically review the regulation of RMs internationally, to identify the regulatory pathways for approved RMs, and to detail expedited programs to stimulate MA process. Official...