The National Medical Products Administration under the State Administration for Market Regulation ("SAMR") has recently completed amendments to three regulations and issued the Administrative Measures for Drug Registration (Draft for Comment) (the "Draft for Comment"), the Measures for Supervision and Administration of Pharmaceutical Production (Draft for Comment) and the Measures for Supervision and Administration of Drug Business Operations (Draft for Comment) to once again seek public comments by November 14, 2019.
The Draft for Comment incorporates the latest requirements regarding administration of drug registration set out in the Drug Administration Law, the Law on Traditional Chinese Medicine and the Law on Vaccine Management, such as the marketing authorization holder system, the acquiescence to clinical trials, the conditional approval, the prioritized evaluation and approval, the classified administration of changes to drugs, and the annual reporting system. The Draft for Comment reflects the "four toughest" requirements, and introduces new regulatory approaches. For instance, information technologies will be employed to ramp up administration of drug registration, and files on drug categories will be formed. Also, the information disclosure requirement is added as required by the recently-revised Drug Administration Law, under which evaluation conclusions and basis, for example, should be made public for public oversight.