The National Medical Products Administration (NMPA) held a meeting on May 11 to carry out the 2023 annual review of the vaccine regulatory quality management system (QMS). NMPA Commissioner Li Li chaired the meeting and evaluated the suitability, adequacy and effectiveness of the NMPA's vaccine regulatory QMS.

The establishment and operation of the vaccine regulatory QMS represents a major effort to meet the assessment requirements of the National Regulatory Authority (NRA) for vaccines of the World Health Organization (WHO) and to enhance the national vaccine regulatory capabilities. The NMPA attaches great significance to the construction of the vaccine regulatory QMS, and is dedicated to promoting the regular and standardized operation of the system to continuously enhance the efficiency of vaccine regulatory work by adhering to goal- and problem-oriented approaches.

At the review meeting, the Department of Policies and Regulations, as the leading department for the construction of the NMPA's vaccine regulatory QMS, reported on the overall situation of the construction and operation of the QMS in 2023, the problems identified and rectifications, as well as suggestions for improving the system. The meeting reviewed the annual operation of the system by the Department of Comprehensive Affairs, Planning and Finance Affairs, the Department of Policies and Regulations, the Department of Drug Registration, the Department of Drug Regulation, and the Department of Human Resources.

Li said that the NMPA, aligning with the requirements of WHO's new round NRA assessment for vaccines, has promoted the construction of the vaccine regulatory QMS and received full recognition from the WHO by formal evaluation in 2022 and subsequent follow-up in 2023, and that the NMPA's vaccine regulatory QMS is suitable, adequate and effective. Relevant departments of the NMPA have earnestly implemented the concept of quality management, adhered to whole-process quality management, and continuously and efficiently carried out internal reviews, which has promoted vaccine regulation in a more compliant, orderly and scientific manner, he added.

Li emphasized the necessity to further deepen and solidify the construction of the NMPA's vaccine regulatory QMS, carry out comprehensive exchanges and training in the regulatory authorities, summarize experiences, and enhance the coordination of the QMS operation among the NMPA, its affiliated institutions, and drug regulatory authorities at all levels, so as to advance China's vaccine regulatory QMS in a more practical and effective manner.