Public Comments Sought by the General Office of the China Food and Drug Administration on the Announcement on Adjusting the Acceptance of Drug Registration Applications (Draft for Comment)

Public Comments Sought by the General Office of the China Food and Drug Administration on the Announcement on Adjusting the Acceptance of Drug Registration Applications (Draft for Comment)

September 12, 2017

For the purpose of implementing the Opinions of the State Council on the Reform of the Evaluation and Approval System for Drugs and Medical Devices (Guo Fa [2015] No.44), drug registration applications previously accepted by provincial food and drug administrations but evaluated and approved by the China Food and Drug Administration ("CFDA") will be accepted in a centralized manner by the CFDA. The CFDA has drawn up the Announcement on Adjusting the Acceptance of Drug Registration Applications (Draft for Comment), which is hereby released for public opinions. Any opinions may be sent to the e-mail address yhzcszhc@cfda.gov.cn by October 12, 2017.

Announcement on Adjusting the Acceptance of Drug Registration Applications (Draft for Comment)

With a view to constructing an evaluation-oriented technical system for drug registration, and achieving an evaluating and approving mechanism with evaluations as the core and on-the-spot examination and product inspection as the technical support, the CFDA has decided in accordance with the Opinions of the State Council on the Reform of Evaluation and Approval System for Drugs and Medical Devices (Guo Fa [2015] No.44) that from December 1, 2017, drug registration applications previously accepted by provincial food and drug administrations but evaluated and approved by the CFDA will be accepted in a centralized manner by the CFDA.
　　......