To implement the relevant requirements of the "Measures for the Administration of Drug Registration" (Order No. 27 of the State Administration for Market Regulation), and to standardize the initiation of drug registration verification and testing, the Center for Drug Evaluation has organized the formulation of the "Trial Procedures for the Initiation of Drug Registration Verification and Testing" (see the attachment). Hereinafter referred to as the "Work Initiation Procedure", it has widely solicited opinions from the industry and relevant departments, verification centers, the National Institutes for Food and Drug Control and other units. After being reviewed and approved by the National Medical Products Administration, it is hereby released and shall come into effect on January 1, 2022. The relevant matters are hereby notified as follows:
(1) Registration applications accepted from the date of implementation of this "Work Initiation Procedure" shall be handled in accordance with the relevant requirements of this procedure. Registration applications accepted before the implementation date shall still be handled in accordance with the original relevant regulations.
(2) For registration applications that fall within the scope of Article 6 of this "Work Initiation Procedure", a complete set of application materials on a CD should be submitted simultaneously at the time of acceptance. Registration applications declared through eCTD shall be handled in accordance with relevant regulations. Where on-site verification of pharmacy is involved, the production process (manufacturing and verification regulations) and quality standards that meet the requirements should be submitted through the applicant's window.
(3) Applicants should have a thorough understanding of the procedures and time limit requirements stipulated in this "Work Initiation Procedure", and prepare the relevant materials needed for the initiation registration verification in advance. Time delays caused by the applicant's reasons shall not be included in the time limit for the review work.
(4) If you have any suggestions for improvement during the implementation of this "Start-up Work Procedure", please email to OC_CDE@cde.org.cn.
This is hereby notified.
Attachment: Work Procedure for Initiating Drug Registration Verification and Inspection (Trial)
Center for Drug Evaluation, National Medical Products Administration
December 17, 2021
Original linkhttps://www.cde.org.cn/main/news/viewInfoCommon/c1dd9f7df30d686a2adab91f7f34587e
