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CFDA Issued the Announcement on Adjusting the Acceptance of Drug Registration Applications
Date:2017-11-13

In accordance with the Opinions of the State Council on the Reform of the Review & Approval System for Drugs and Medical Devices (SC [2015] No. 44), CFDA hereby decides through discussion that, as from December 1, 2017, CFDA will accept in a centralized manner the drug registration applications that were previously accepted by the food and drug regulatory authorities at the provincial level and then subject to review and approval of CFDA, with a view to establishing a review and approval dominated drug registration technology system and realizing a review and approval mechanism focused on review and approval and technically supported by onsite inspection and product testing. On November 13, 2017, CFDA published the Announcement on Adjusting the Acceptance of Drug Registration Applications to provide details below:

I. Adjusted items Subsequent to the adjustment, all drug registration applications that should be reviewed, approved and filed by CFDA pursuant to applicable laws, regulations and rules will be accepted by CFDA, covering new drug clinical trial application, new drug manufacturing (or new drug certificate) application, application for generic drug, supplementary application reviewed and approved by CFDA and so on; all drug registration applications that should be reviewed, approved and filed by the food and drug regulatory authorities at the provincial level pursuant to applicable laws, regulations and rules will be still accepted by such food and drug regulatory authorities at the provincial level. II. Requirements The said adjustment shall take effect as from December 1, 2017. The drug registration application dossiers may be submitted via email, mailing or personal delivery, the hard copy and electronic copy of which shall be submitted at the same time. Prior to December 1, 2017, the registration application dossiers signed for receipt but not yet accepted, or already accepted but for which such affairs as on-site inspection for drug clinical trial, research and development site inspection, production site inspection, and sampling, etc. remain outstanding, shall be still handled by the food and drug regulatory authorities at the provincial level.

III. Submissions The drug registration applicant shall fill in an Application Form and prepare the application dossiers in accordance with the Provisions for Drug Registration, the Style and Arrangement Specification for Drug Registration Application Dossiers, and other relevant regulations, and shall ensure the consistency between the hard copy and electronic copy thereof. The drug registration applicant may submit application dossiers via mailing (which is the preferred method) or personal delivery. (1) Delivery via mailing. The drug registration applicant shall mail the application dossiers to Center for Drug Evaluation, CFDA (hereinafter referred to as “CDE”). Mailing address: No. 1A, Fuxing Road, Haidian District, 100038 Beijing. The electronic copy of application dossiers mailed should be technically secured in a storage media to avoid the unacceptability of application dossiers due to damage to such media arising during the mailing process. (2) Personal delivery. The drug registration applicant shall submit the drug registration application to CDE together with relevant dossiers. Office address: No. 1A, Fuxing Road, Haidian District, Beijing Business hours: 9:00 a.m. to 11:30 a.m. from Monday to Friday; 13:00 p.m. to 16:00 p.m. on Monday, Tuesday and Thursday. (3) Requirements on submissions. The drug registration applicant shall submit the application dossiers in a manner as required by the applicable requirements on drug registration dossiers. If a new drug clinical trial application is submitted, the opinions and suggestions communicated at the meeting with CDE and statements on supplement to application dossiers shall be accompanied. IV. Acceptance review CDE shall sign for its receipt of application dossiers and make a registration on that day or immediately when receiving such dossiers, and shall, within five (5) working days thereafter, complete the acceptance review and make a decision thereon (acceptance, rejection or requiring the supplementation of materials). If the application dossiers are reviewed and confirmed to be compliant with the regulations or supplemented and confirmed to be compliant with the regulations, CDE shall issue a Notice of Acceptance and a Notice on Payment; if the application dossiers are reviewed and confirmed to be noncompliant with the regulations, CDE shall issue a Notice on Supplementation of Materials or a Notice on Rejection. Such notices shall be sent to the drug registration applicant within five (5) working days upon receipt. The drug registration applicant may provide the supplements via personal delivery or mailing. Where CDE fails to receive the supplements within thirty (30) days after the Notice on Supplementation of Materials is served, for which neither a notification nor any justification is provided by the applicant timely, CDE shall issue a Notice on Rejection and return the application dossiers to the registration applicant. V. Filing review Upon acceptance of application dossiers, CDE shall conduct a filing review over application dossiers for chemical generic drugs and make a filing for those that are compliant with the requirements within forty-five (45) working days thereafter and disapprove those that are noncompliant with the requirements with justification stated. VI. On-site verification and test for registration The drug registration inspectors nationwide shall be organized by the Center for Food and Drug Inspection of CFDA in a unified manner to conduct on-site verification over all drug registration applications newly accepted in a centralized manner by CFDA according to requirements for drug technical review, which will not be subject to the selfinspection and verification of drug clinical trial data conducted by CFDA as from July 2015. As for the drug under registration application requiring test for registration or sampling test as deemed necessary during on-site verification, the samples shall be taken and delivered to the National Institutes for Food and Drug Control or the drug testing institution at the provincial level by the inspection department as per the regulations. The verification report, and testing report, etc. shall be still delivered to CDE as per applicable regulations. Each food and drug regulatory authority at the provincial level shall strengthen the publicity of the Announcement and make a timely report of major problems.

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