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What procedures are required for filing with the Food and Drug Administration?

Take the filing of drug packaging labels and instructions as an example. The service procedures are as follows:

(1) The applicant submits application materials to the provincial bureau’s government affairs acceptance department. The provincial bureau's government affairs acceptance department will conduct the review within 5 working days. If the requirements are met, an "Acceptance Notice" will be issued and the materials will be transferred to the review and certification center;

(2) The review and certification center will open on 15 After completing the review work within 10 working days, the review opinion will be issued and the materials will be transferred to the Drug and Cosmetic Registration Office;

(3) The Drug and Cosmetic Registration Office will complete the review within 10 working days and prepare a supplementary application record. The electronic version or the "Notice of Approval Opinions" will be handed over to the provincial bureau's government affairs acceptance department;

(4) The Drug and Cosmetic Registration Management Office will upload the electronic version of the supplementary application filing to the State Administration's database within 5 working days; The administrative affairs acceptance department of the bureau will issue a "Notice of Approval Opinions" to the applicant within 5 working days;

(5) If it must be reported to the National Bureau for approval, it shall be handled in accordance with the provisions of the "Measures for the Administration of Drug Registration";

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(6) Due to special circumstances such as equipment technology and other reasons, it is really difficult to print the common name, specifications, production batch number and validity period on the label of individual varieties, which shall be accepted by the provincial bureau and reported to the national bureau for approval. After approval, Label content can be reduced.

Extended information:

Function changes

(1) Responsibilities eliminated.

1. The two administrative licenses of drug production administrative license and drug production quality management practice certification will be gradually integrated into one administrative license.

2. The two administrative licenses of pharmaceutical business administrative license and pharmaceutical business quality management standard certification will be gradually integrated into one administrative license.

3. Integrate the two administrative licenses of cosmetics production administrative license and cosmetics hygiene administrative license into one administrative license.

4. The continuing education management responsibilities of practicing pharmacists are cancelled, and the work will be undertaken by the Chinese Practicing Pharmacists Association.

5. Other responsibilities that need to be eliminated according to the "State Council Institutional Reform and Function Transformation Plan".

(2) Decentralized responsibilities.

1. Decentralize the responsibility for quality management specification certification of drugs and medical devices to provincial food and drug regulatory authorities.

2. The responsibilities for drug re-registration and supplementary application for administrative licenses that do not change the intrinsic quality of the drug will be delegated to the provincial food and drug regulatory authorities.

3. The responsibility for applying for administrative licenses for changes to domestic Class III medical devices that do not change the intrinsic quality of the product will be delegated to the provincial food and drug regulatory authorities.

4. Decentralize administrative licensing responsibilities for drug production entrustment to provincial food and drug regulatory authorities.

5. The administrative licensing responsibilities for imported non-special purpose cosmetics will be delegated to provincial food and drug regulatory authorities.

Baidu Encyclopedia-State Food and Drug Administration