Regulation Policy on Cell- and Tissue-Based Therapy Products in Korea.

Extensive investment on research and development of cell therapy products (CTPs) and tissue-engineered products (TEPs) has been made in Korea, and various commercial products are born in market. The Ministry of Food and Drug Safety (MFDS) in Korea regulates CTPs and TEPs as biological products under the authority of the Pharmaceutical Affairs Act. The Korean MFDS approved 16 CTPs and 4 stem CTPs and authorized 135 clinical trials, including 60 sponsor-investigator trials. Currently, the advent of stem cell technology and new biomaterials gives an impetus to develop more innovative CTPs and TEPs to treat intractable and serious diseases. This article deals about the regulatory process for approving CTPs and TEPs in Korea. Regulatory policies of the MFDS for supporting the development of novel products and ensuring the safety of the CTPs and TEPs are reviewed.