China details outsourced manufacturing pilot program

China's State Council outlined details of its three-year Marketing Authorization Holder (MAH) System pilot program, which in some geographies lifts a requirement that only drug manufacturers can obtain licenses to market drugs, according to law firm Ropes & Gray. Chinese drug developers that hold marketing authorizations for some drugs may now outsource drug manufacturing if both the developer and manufacturer are located within the pilot region, the firm said.

The program applies in the cities of Beijing, Shanghai and Tianjin, as well as Zhejiang, Jiangsu, Guangdong, Hebai, Fujian, Shandong and Sichuan provinces, according to Ropes. ...