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Provincial-level Food and Drink Administrations Lose Pharmaceutical Licensing Approval Rights

Provincial-level food and drink administrations are to lose their entitlement to monitor and approve activities in three pharmaceutical-related licensing sectors. A notice to this effect has been issued by the China Food and Drug Administration (CFDA) and follows an earlier ruling by the State Council.

The three sectors where provincial-level food and drink administrations are to lose their jurisdiction are as follows:

1. The examination and approval of the registration of pharmaceutical excipients (excluding excipients for new drugs and imported drugs).

2. Any preliminary examination for the accreditation of institutions with regard to clinical trials of pharmaceutical products.

3. The examination and approval of online pharmaceutical-trading enterprises (except third-party platforms).

Following the issue of the State Council’s Decision on Cancelling the Third Batch of Administrative Licensing Items Designated by the Central Government for Implementation by Local Authorities on 21 January 2017 (Guofa No. 7 [2017]), all provincial-level food and drug administrations have ceased to accept applications related to the three designated licensing sectors, In the case of applications accepted prior to the date of the ruling,  but not approved as  of the date of issue, the approval process will be terminated and any application documents returned to the applicants in question.

For further details (in Chinese), please visit the following website:  

Notice of the CFDA on Work Relating to the Implementation of the Decision of the State Council on Cancelling the Third Batch of Administrative Licensing Items Designated by the Central Government for Implementation by Local Authorities

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