The China Food and Drug Administration ("CFDA") has recently drafted and issued the Announcement on Adjusting the Acceptance of Drug Registration Applications (Draft for Comment) (the "Draft for Comment") for public comments by October 12, 2017.
The Draft for Comment expressly states that from December 1, 2017, a drug registration application that should be accepted by a provincial authority and then evaluated and approved by the CFDA according to the existing policy will be accepted and handled by the CFDA in a centralized manner thereafter. According to the Draft for Comment, any drug registration application subject to the evaluation and approval of the CFDA, such as an application for applying a new drug to clinical tests, an application for generic drugs, a supplementary application to be approved by the CFDA, and an application for reporting the drug package materials or pharmaceutical excipients associated with an application for registering a domestic drug, will be accepted and handled by the CFDA. However, any drug registration application subject to approval of a provincial authority shall be still accepted and handled by such provincial authority as before. Moreover, the Draft for Comment sets forth that for a drug registration application that has been received but not yet accepted by the provincial authority before December 1, the provincial authority shall still take charge of the acceptance, on-site inspections, production site inspections and sampling and other necessary work.