CFDA unveils guidelines for conditional approval, compassionate use

China FDA issued draft guidelines on a conditional approval pathway for life-threatening rare diseases and the compassionate use of investigational candidates. CFDA developed the guidelines to accelerate patient access to clinically urgent drugs based on recommendations from the country's State Council. The State Council issued the directive ahead of the 19th National Congress of the Communist Party of China in October (see BioCentury Extra, Oct. 9).

The draft says companies can apply for conditional approval based on surrogate or intermediate clinical trial endpoints, including biomarkers, and early or mid-term data showing advantages over current therapies. Clinical data that supported approval in other countries can also be used to gain conditional approval in China. Comments on the draft are due Jan. 14...