The evolving regulatory system of advanced therapy medicinal products in China: a documentary analysis using the World Health Organization Global Benchmarking Tool standards

• Published in: Cytotherapy (Oxford, England) Vol. 26; no. 8; pp. 954 - 966
• Main Authors: Shi, Junnan, Chen, Xianwen, Hu, Hao, Ung, Carolina Oi Lam
• Format: Journal Article
• Language: English
• Published: England Elsevier Inc 01.08.2024
• Subjects: Advanced Basic Science; advanced therapy medicinal products; Benchmarking - methods; China; drug regulatory authority; Global benchmarking Tool (GBT); Humans; Other; regulatory science; World Health Organization; China; advanced therapy medicinal products; drug regulatory authority; Global benchmarking Tool (GBT); regulatory science; China

Advanced therapy medicinal products (ATMPs) are rapidly evolving to offer new treatment options. The scientific, technical, and clinical complexities subject drug regulatory authorizes to regulatory challenges. To advance the regulatory capacity for ATMPs, the National Medical Products Administratio...