CFDA implements new drug approval policies

China FDA said new drug approval policies previously announced by the State Council will go into effect on Dec. 1. The initiatives aim to reduce time to market for new drugs and promote innovation in China, according to an analysis by law firm Ropes & Gray (see BioCentury, Oct. 19).

CFDA will update its definition of a new drug to include therapeutics not yet approved anywhere in the world. Previously, the agency categorized new drugs as therapeutics not yet approved in China. Ropes & Gray's Katherine Wang told BioCentury that while the policy applies primarily to new applications, sponsors of applications currently under review may request expedited approval if they meet program requirements. ...