Procedures for initiating verification and testing of drug registration (Trial) in 2022

On December 20, 2022, the CDE (Center for Drug Evaluation) published (No.54-2021) the trial working procedures for initiating drug verification and testing with immediate effect from January 1, 2022, onwards. The trial working procedures is a supplementary regulation to the SAMR (State Administration for Market Regulation) Order No.27 on Administrative Measures for Drug Registration.

According to the trial regulation, the CDE will determine whether on-site verification needs to be initiated based on the risk factors of the drug itself and compliance factors of R&D and production entities.

Highlights

• For drug registration applications that require the initiation of drug verification, the CDE shall notify the CFDI (Center for Food and Drug Inspection) to start the verification process within 40 working days after the application for drug registration is accepted, and the CDE will hand over the verification tasks and the related materials to the CFDI.  In principle, the on-site verification should be completed in 40 working days before the end of the review period. The results will be provided back to the CDE for review and submitted along with the dossier for drug registration.

• Chapter 5 of this working procedure specifies the drug registration applications that require drug testing, which is consistent with the original relevant regulations and will not be repeated here.

• For drug registration applications, the time limitation for drug testing from start to finish is the same for drug verification.

By Yu Fang and Jacky Li. Contact Cisema if you would like to learn more.