China Begins Marketing Authorization Holder Pilot Program

To encourage innovative drug development, China's State Council recently announced rules for a Marketing Authorization Holder pilot program: drug R&D institutions and individuals will now be able to apply for and hold CFDA approvals without having an in-house manufacturing capability. Previously this was not possible. Without incurring the expense of building a manufacturing operation, drug R&D companies and institutions can develop drugs, engage a contract manufacturer, apply for approval and market the drugs. More details.... Share this with colleagues: // //