Qualified research institutions that develop their own pharmaceuticals will be eligible to hold marketing authorization permits in China under new legal guidance that went into effect in late September. Since 2015, when China first began implementing its Marketing Authorization Holder (MAH) system, only pharmaceutical producers with facilities meeting China’s Good Manufacturing Practices standards of quality and safety could receive the MAH designation, which permits the holder to manufacture and sell pharmaceuticals.
Under the new guidance from China’s National Medical Products Administration, individual research and development institutions that develop their own pharmaceuticals can be Market Authorization Holders as long as they contract with a qualified manufacturing facility to produce the drugs. As the marketing authorization holder, the research and development institution is legally responsible for the safety, effectiveness, and quality control of their pharmaceutical products.