China’s CDE Expands Market Approval Services with Two New Regional Windows

The China Center for Drug Evaluation (CDE) has announced the establishment of two additional external acceptance service windows at the National Medical Products Administration (NMPA) subcenters in the Yangtze River Delta and the Greater Bay Area. These service windows will commence operations from December 1, 2023, and will be responsible for accepting market approval filings within their respective regions. According to CDE guidance, the submission method and location for filing materials will remain unchanged.

The Yangtze River Delta region encompasses Shanghai, Jiangsu, Zhejiang, and Anhui, while the Greater Bay Area comprises the Hong Kong Special Administrative Region, the Macau Special Administrative Region, and the Guangdong cities of Guangzhou, Shenzhen, Zhuhai, Foshan, Huizhou, Dongguan, Zhongshan, Jiangmen, and Zhaoqing.- Flcube.com

Fineline Info & Tech