Notice on Issuing the 2023 Drug Inspection Capability Verification Plan by the Comprehensive Department of the National Drug Administration

Drug Administration Comprehensive Department Wai [2023] No. 21

To the drug regulatory bureaus of various provinces, autonomous regions, municipalities directly under the central government, and Xinjiang Production and Construction Corps, as well as the China Food and Drug Control Research Institute and relevant drug inspection and testing institutions:

According to the Implementation Opinions of the General Office of the State Council on Comprehensively Strengthening the Construction of Drug Supervision Capacity (Guo Ban Fa [2021] No. 16) and the Notice of the Comprehensive Department of the State Food and Drug Administration on Strengthening and Improving the Verification of Drug Inspection and Testing Capacity (Yao Jian Zong Ke Wai [2020] No. 67), in order to enhance the capacity and level of drug, medical device, and cosmetic inspection and testing institutions under the new situation, The National Food and Drug Administration has organized the development of the 2023 Drug Inspection Capability Verification Plan, which is organized and implemented by the China Food and Drug Control Research Institute.

Drug inspection capability verification is an important means to effectively improve laboratory capabilities and an important component of drug safety assessment work. Please actively organize, coordinate, and guide key laboratories of the National Drug Administration and provincial, municipal, and county-level inspection and testing institutions and laboratories within their respective administrative regions to participate in the capacity verification plan; At the same time, organize and guide provincial-level inspection and testing institutions within the administrative region to strengthen their business guidance to municipal and county-level inspection and testing institutions, and improve the participation rate and satisfaction rate of participating in drug inspection capability verification.

After the completion of the drug inspection capability verification work, the National Drug Administration will calculate the participation rate and satisfaction rate of drug inspection capability verification in each province, and use it as a reference for the year-end work assessment.

Participants who are satisfied with the results of the proficiency test by the National Drug Administration will publish a list of inspection and testing institutions and laboratories in accordance with the procedures; Participants who are not satisfied with the results of their ability verification should suspend relevant inspection and testing activities on their own until their technical level is effectively verified before resuming the inspection and testing activities.

Please submit the relevant information on drug inspection capability verification to the Science and Technology Department of the State Food and Drug Administration before the end of October 2023. The relevant information should include: basic information of inspection and testing institutions, participation in capacity verification, failure to participate in capacity verification, existing problems, next steps of work, and relevant suggestions.

Contact person and phone number:

Research Center for Capability Evaluation of Inspection Institutions of China Academy of Food and Drug Control:

Liu Yadan, 010-53851487; Xiang Xinhua, 010-53851353.

Science and Technology Cooperation Department of the National Drug Administration:

Gan Shide, 010-88330562; Jiang Lu, 010-88330502.