ABSTRACT
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 chapter aims to systematically review the regulation of RMs internationally to identify the regulatory pathways for approved RMs and to detail expedited programs to stimulate the MA process. The results show that specific RM legislation/frameworks were available in the EU, USA, Japan, South Korea, and Australia. A risk-based approach exempting eligible RMs from MA regulations was adopted in the EU and six countries. All investigated regions have established accelerated review or approval programs to facilitate the MA of RMs, such as the Priority Medicine (PRIME) designation in the European Union, Regenerative Medicine Advanced Therapy (RMAT) designation in the United States, and SAKIGAKE (forerunner initiative) designation in Japan. Although regulators have adopted proactive strategies to facilitate RM approval, addressing the discrepancies in regulatory requirements internationally remains challenging.
