The China Food and Drug Administration ("CFDA") has recently issued the Announcement on Adjusting the Acceptance of Drug Registration Applications (the "Announcement").
The Announcement expressly states that, any drug registration application that is required to be evaluated and examined by or filed under the record with the CFDA under existing laws, regulations and rules shall be accepted and handled by the CFDA, including the application for conducting clinical trials for a new drug, the application for manufacturing a new drug (including obtaining a certificate for the new drug), the application for a generic drug, and the supplementary application that shall be examined by the CFDA; drug registration applications that shall be examined by or filed under the record with the provincial food and drug administrations will still be accepted and handled by such provincial food and drug administrations. The above-said adjustment will take effect from December 1, 2017. The Announcement adds that, the Center for Food and Drug Inspection of CFDA will arrange for nationwide drug registration inspecting resources in a centralized manner to carry out inspections on the spot for each drug registration application the CFDA has accepted after the centralized acceptance has been in force, and such application newly accepted thereafter shall not be subject to the self-checking and inspection program for the clinical trial data of drugs that has been underway by the CFDA since July, 2015.