BioCentury
ARTICLE | Politics & Policy

China revising drug approval requirements

November 6, 2015 3:27 AM UTC

China's State Council announced a pilot program that will allow pharmaceutical companies to seek marketing authorizations for new drugs separately from manufacturing licenses. The three-year program will be tested in 10 provinces and cities, including Beijing, Shanghai, Tianjin, Zhejiang and Jiangsu.

The Council said the program will promote innovation and encourage drug developers to optimize their resources. Under current rules, only drug manufacturers can obtain marketing authorizations. The program goes into effect Thursday. Any drugs approved during the pilot period will retain approval after the program expires. ...