On November 13, 2017, the CFDA official website issued the "Notice on Adjusting the Acceptance of Drug Registration by the General Administration of the People's Republic of China (No. 134 of 2017)", and all applications for drug registration for review and approval were unified for the State Food and Drug Administration. The rights of the provincial food and drug supervision and administration departments to accept the examination and approval were taken back.

The full text is introduced as follows:

Announcement of the General Administration of the State on Adjusting the Acceptance of Drug Registration (No. 134 of 2017)

According to the "Opinions of the State Council on Reforming the Examination and Approval System for Pharmaceutical Medical Devices" (Guo Fa [2015] No. 44), in order to establish a review-led drug registration technology system, the evaluation will be evaluated as the core, on-site inspection and product inspection as technology. Supported by the review and approval mechanism, the State Food and Drug Administration has decided to apply for drug registration that has been accepted by the provincial food and drug supervision and administration department and reviewed and approved by the State Food and Drug Administration since December 1, 2017. The adjustment was centralized for the State Food and Drug Administration. The relevant matters are hereby announced as follows:

First, the scope of adjustment

All applications for registration, examination and approval, and filing by the State Food and Drug Administration are accepted by the State Food and Drug Administration, including applications for new drug clinical trials, new drug production (including new drug certificates), and imitations. Pharmaceutical applications, supplementary applications approved by the State Food and Drug Administration, etc.; applications for drug registration approved and filed by the provincial food and drug supervision and administration department shall still be accepted by the provincial food and drug supervision and administration department.

Second, the adjustment requirements

The above adjustments will be implemented from December 1, 2017. Drug registration applications can be submitted by electronic filing, mailing or on-site submission, and paper and electronic documents can be submitted at the same time.

Before December 1, 2017, the provincial food and drug supervision and administration department has signed the application but has not accepted or accepted the application, but the drug clinical trial site verification, development site verification, production site inspection and sampling have not yet completed the registration application, still by the province The food and drug supervision and administration department organizes the relevant work.

Third, the data submission

Applicants for drug registration shall fill in the application form and prepare the application materials in accordance with the relevant provisions of the Measures for the Administration of Drug Registration, the Rules for the Registration and Filing of Drug Registration, and other relevant regulations. Applicants should ensure that the paper text submitted is consistent with the content of the electronic document. Applicants for drug registration may choose to submit the application materials by post or on-site, and encourage drug registration applicants to submit the application materials by mail.

(1) Submit by mail. The applicant for drug registration will mail the relevant materials to the Drug Evaluation Center of the State Food and Drug Administration (hereinafter referred to as the Drug Administration Center of the General Administration).

Mailing address: No.1, Fuxing Road, Haidian District, Beijing, China, 100038.

The applicant shall submit the technical protection of the storage medium by mail to submit the application materials of the electronic document, so as to avoid the unacceptable application of the media during the mailing process.

(2) Submit on site. The drug registration applicant submits the drug registration application to the Drug Administration Center of the General Administration with relevant information.

Office Address: No.1, Fuxing Road, Haidian District, Beijing

Office hours: Monday to Friday, morning: 9:00-11:30; Monday, Tuesday, Thursday, afternoon: 13:00-16:00.

(3) Information submission requirements. Applicants for drug registration shall submit the application materials in accordance with the requirements of the current drug registration materials; if they submit applications for clinical trials of new drugs, they shall submit a communication with the General Administration of Drug Administration and a supplementary explanation of the application materials.

IV. Acceptance review

The General Administration of Drug Control will receive the registration on the day of receipt of the information or on the spot, and complete the acceptance review within 5 working days and make a review decision (acceptance, non-acceptance or request for correction). If the examination meets the requirements or the applicant complies with the provisions after completing the correction information, it shall issue a Notice of Acceptance and a Notice of Payment; if the examination fails to meet the requirements, a Notice of Correction Information or Notice of Non-Acceptance shall be issued. . The notice of review decision shall be sent to the applicant for drug registration within 5 working days.

After the drug registration applicant completes the correction information as required, it may choose to submit the correction information on the spot or by post. If the correction information is not received within 30 days from the date of delivery of the Notice of Correction Information, and the applicant for drug registration fails to communicate with the drug inspection center of the General Administration in time and explain the reasons, the Notice of Non-acceptance will be issued and the application materials will be submitted. Return the applicant.

V. Volume review

After the acceptance, the General Administration Drug Evaluation Center shall conduct a review of the chemical drug generic drug application materials, and if it meets the requirements, it shall complete the establishment within 45 working days; if it does not meet the requirements, it shall not be approved, and the reasons shall be explained.

VI. On-site verification and registration inspection

After the centralized acceptance, the newly accepted drug registration application by the State Food and Drug Administration will be organized by the Food and Drug Inspection and Inspection Center of the State Food and Drug Administration to conduct on-site verification of the national drug registration inspection resources according to the requirements in the drug technical review. It will no longer be included in the scope of self-inspection and verification of drug clinical trial data conducted by the State Food and Drug Administration since July 2015. If it is necessary to carry out the registration inspection or the verification is deemed to require the sampling inspection, the inspection department shall, according to the regulations, take samples and send them to the China Food and Drug Testing Institute or the provincial drug inspection agency for inspection. The verification report and inspection report are still submitted to the Drug Administration Center of the General Administration in accordance with the current regulations.

All provincial food and drug supervision and administration departments shall strengthen publicity and implementation, and report in time when major problems are encountered.

  Special announcement.

Food and Drug Administration

November 7, 2017