Announcement of the China Food and Drug Administration on Adjusting the Acceptance of Drug Registration Applications
Announcement of the China Food and Drug Administration on Adjusting the Acceptance of Drug Registration Applications
Announcement of the China Food and Drug Administration on Adjusting the Acceptance of Drug Registration Applications
Announcement of the China Food and Drug Administration [2017] No.134
November 7, 2017
With a view to developing 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 production inspection as the technical support, the China Food and Drug Administration ("CFDA"), upon deliberation, has decided in accordance with 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), that from December 1, 2017, the CFDA shall accept and handle the drug registration applications in a centralized manner which are previously accepted by provincial food and drug administrations and evaluated and approved by the CFDA. Relevant matters are hereby notified.
I. Adjustment Scope
Any drug registration application subject to the evaluation and approval and record-filing process by the CFDA pursuant to the existing laws, regulations and rules shall be accepted and handled by the CFDA, including applications for clinical trials of new drugs, for manufacture of new drugs (including for New Drug Certificates), for generic drugs, supplementary applications to be approved by the CFDA, etc.; and the drug registration applications subject to the approval and record-filing by the competent provincial food and drug administrations shall still be accepted and handled by such administrations as before.
......
Announcement of the China Food and Drug Administration [2017] No.134
November 7, 2017
With a view to developing 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 production inspection as the technical support, the China Food and Drug Administration ("CFDA"), upon deliberation, has decided in accordance with 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), that from December 1, 2017, the CFDA shall accept and handle the drug registration applications in a centralized manner which are previously accepted by provincial food and drug administrations and evaluated and approved by the CFDA. Relevant matters are hereby notified.
I. Adjustment Scope
Any drug registration application subject to the evaluation and approval and record-filing process by the CFDA pursuant to the existing laws, regulations and rules shall be accepted and handled by the CFDA, including applications for clinical trials of new drugs, for manufacture of new drugs (including for New Drug Certificates), for generic drugs, supplementary applications to be approved by the CFDA, etc.; and the drug registration applications subject to the approval and record-filing by the competent provincial food and drug administrations shall still be accepted and handled by such administrations as before.
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