China Launches Drug Marketing Authorisation Holder System

Revised provisions for drug registration and the supervision of drug production recently announced by the State Administration for Market Regulation will take effect on 1 July 2020. Both sets of provisions promote the full implementation of the marketing authorisation holder (MAH) system for drugs. Pharmaceutical innovation, continuous improvements to systems for drug evaluation, review, approval and production licensing, and the development of efficient scientific evaluation, review and approval procedures are encouraged. Focus is to be put on addressing outstanding problems in drug registration and the supervision of drug production. Short-supply drugs that meet urgent clinical needs, pediatric drugs, drugs to treat rare diseases and major infectious diseases, vaccines urgently needed for disease prevention and control, and innovative vaccines are all identified  for expedited marketing registration. On the full implementation of the MAH system, it is clearly specified that the applicants must be enterprises or drug research and development institutions capable of bearing the corresponding responsibility. Meanwhile, on the optimisation of evaluation, review and approval procedures, express channels are to be established for breakthrough therapy, conditional approval, priority evaluation, review and approval, and special approval.

Source: State Administration for Market Regulation