China Drug Regulator Mulls Tightening Conditional Approvals

China’s top drug regulator is planning to impose more stringent rules on how conditional approval, the equivalent of the US Food and Drug Administration’s accelerated approval scheme, will be granted after a more than two-year trial of the program.

The National Medical Products Administration (NMPA) will initiate an amendment to the Pilot Procedure for Review and Approval of New Drug Application for Conditional Approval in the near future, Sheng Yang, head of its Department of Drug