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| Notice concerning adjustment of drug registration acceptance work |
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| Author：中國銘鉉 企劃部 Release Time：2017-9-14 10:38:28 Number Browse：952 |
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On September 13, September 13, 2007, the notice concerning adjusting the registration of pharmaceutical products (soliciting submissions) was posted on CFDA's official website, and the time for consultation was dated to October 12, 2017.
Notice concerning adjustment of drug registration acceptance work
(draft)
In accordance with the state council on drug review of medical equipment examination and approval system reform opinions "(guo fa [2015] 44), the technology of drug registration system for the review and implementation based on the review, on-site inspection, product inspection for the technical support for examination and approval of the review mechanism, the state food and drug administration and decision research since December 1, 2017, will now by provincial food and drug supervision department, food and drug supervision administration for examination and approval of the review for drug registration, adjusting to the food and drug supervision bureau concentrated accepted. The relevant issues are hereby announced as follows:
1. Scope of adjustment
Application for registration by the administration for examination and approval of the review are shall be accepted by the administration, such as new drug clinical trials, drug production (including the new drug certificate) applications, generic application, administration examination and approval of the supplement and associated with domestic drug registration filing application for drug packaging, pharmaceutical excipients, etc. The registration application for drugs approved by the provincial food and drug administration is still accepted by the provincial food and drug administration.
Adjustment requirements
The above adjustment shall be implemented as of December 1, 2017, and the application for registration of drugs may be submitted by electronic declaration, post or site submission, and submit both paper and electronic documents.
On December 1, 2017, the provincial food and drug regulatory department has to sign for information but have not yet accepted the application for registration of, is still done by provincial food and drug supervision department organization acceptance, production site inspection, the inspection and sampling and other related work.
Iii. Information submission
The applicant for drug registration shall fill in the application form and prepare to declare the information in accordance with the regulations on the registration of drugs and the regulations on the registration of drug registration.
(1) by mail. The applicant shall post the relevant information to the national food and drug administration for administrative matters and the complaint reporting centre (hereinafter referred to as the general administration of the general administration for acceptance and reporting).
Mailing address: no.28, dacheng plaza, no.28, xuanwu gate, xicheng district, Beijing city, China, zip code: 100053 (tentative).
The applicant should provide the technical protection of the storage medium and avoid the risk of not receiving the information due to the damage caused by the media damage in the mailing process.
(2) site submission. The applicant shall submit the application for drug registration to the center for acceptance and reporting.
Office address: no.28, dacheng plaza, no.28, xuanwu gate, xicheng district, Beijing.
Office hours: Monday to Friday morning: 9:00-11:30; Monday, Tuesday, Thursday, afternoon: 13:00-16:00.
Iv. Information signing
If the information is sent by mail, the bureau shall register the information on the date of receipt of the information. If the information is submitted on the spot, the office of the general administration of the general administration and the reporting center shall issue the "document receipt" on the spot and send it to the applicant.
V. acceptance of review
The general administration accepts and reports the centre within 5 working days after receiving the data to review and make a review decision (accept, refuse to accept or ask for supplementary material).
Through examination of provisions package information in conformity with the provisions, or the applicant to complete the acceptance notice issued by the payment notice and other relevant documents, delivery or send the drug registration applicant on the spot.
If the examination fails to meet the requirements, the notice of correction shall be issued and delivered on the spot or within 5 working days.
After the applicant completes the supplementary information according to the requirements, he may select the site submission or submit the supplementary information by post. If there is no positive information received within 30 days from the date of delivery of the notice of correction, the notice of acceptance shall be issued and the application shall be returned to the applicant.
Vi. Site verification and registration inspection
After the implementation of centralized acceptance, on-site verification shall be carried out by the unified organization of the verification center of the general administration. If registration is required, the inspection department shall take samples to be sent to the inspection institute or provincial drug inspection authorities for inspection. The verification report and inspection report shall be submitted to the pharmaceutical audit center of the general administration in accordance with the present provisions.
Provincial food and drug supervision and administration departments should strengthen their publicity and report on major issues.
Hereby notice.
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