China's State Council outlines drug reforms

Ahead of the 19th National Congress of the Communist Party of China on Oct. 18, the country's State Council issued guidelines to reform the drug approval process. The opinions, which were released right after China's Golden Week holiday, propose steps to change clinical trial procedures, expedite regulatory review and promote drug innovation and generics.

On clinical trial reform, the State Council suggests optimizing clinical trial approval by strengthening communication between applicants and review institutions. The State Council also supports expanding clinical trials by allowing patients with diseases without current treatments to receive experimental treatments, and allowing the resulting safety data to be used during registration. The proposals also include allowing clinical trial data from outside China to be accepted during registration...