Mar. 17, 2017
The CFDA has published suggested amendments to its foreign drug registration rules. The proposed amendments are designed to overcome the present hurdles associated with foreign-approved drug registration in China.
The proposal suggests opening up China to multi-center global trials and admitting the results obtained from such trials in the local drug registration process.
If implemented, the proposal may save years of local parallel development and shorten the time-to-market of new drugs, to the benefit of both pharma companies and the general public.