CFDA proposes changes to Drug Administration Act

China FDA proposed amendments to the country's Drug Administration Act that it hopes will encourage innovation while shortening drug approval timelines. The proposals include full implementation of the Marketing Authorization Holder (MAH) system, which allows China drug developers to outsource manufacturing; certification of China clinical trial institutions' Good Laboratory Practice (GLP) status through a registration system rather than CFDA approval; and permitting sponsors to start clinical trials 60 days after submitting an IND unless CFDA intervenes.

The proposals also include a new classification system for small molecules, biologics and traditional Chinese medicines that is more in line with international standards for new drugs and biologics, generics and biosimilars. Comments on the proposed amendments are due by Oct. 30...