CFDA implements reforms to trials, drug reviews

China FDA implemented reforms to rules governing multicenter clinical trials and the drug registration and approval process, a day after the country's State Council issued a broader policy directive laying out guidelines for reforms.

CFDA said multicenter Phase I trials can now be conducted simultaneously in China and overseas. The agency said drug candidates in those trials no longer must be registered in another country or be in Phase II or III studies, with the exception of preventative biologics. Upon a multicenter trial's completion in China, a sponsor may submit an NDA to the agency. ...