NMPA holds meeting to review vaccine regulation and quality management system
On May 4, the National Medical Products Administration (NMPA) held a review meeting on the vaccine regulation and quality management system in 2022, to summarize the construction and operation of the system, evaluate its appropriateness, effectiveness and adequacy, and make arrangements for the key tasks in the next stage.
NMPA Commissioner Jiao Hong attended the meeting. NMPA Deputy Commissioner Huang Guo presided over the meeting.
The establishment of a vaccine regulation and quality management system is a basic element in the World Health Organization (WHO) National Regulatory Authority (NRA)'s assessment of vaccines, and also an internal demand to comprehensively improve China's vaccine regulatory capacity and promote the healthy development of China's vaccine industry. The NMPA attaches great significance to its construction, integrates the requirements of the NRA assessment with regulatory practices, and consistently advances the construction of its vaccine regulation and quality management system, which has greatly improved science-based and standardized vaccine regulation.
At the meeting, the NMPA’s Office of Vaccine Regulation and Quality Management System reported the overall situation in the construction and operation of the system in 2022. 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 respectively reported the operation of the system in each department. In 2022, the NMPA advanced the quality management system based on the vaccine NRA assessment, formulated and updated procedural documents to standardize the regulatory process, improved its work through research and studies, elevated the operating efficiency and quality of the system via internal reviews, and enhanced the quality management capability of related personnel by strengthening training. Remarkable progress has been made in the construction of the vaccine regulation and quality management system.
The meeting fully affirmed the outcomes in the construction of the vaccine regulation and quality management system. The NMPA has been building the system in line with China's national conditions and improving the overall quality and effectiveness of vaccine regulatory work, which has played a positive role in enabling China to pass the latest vaccine NRA assessment. The meeting noted that in the past year, the vaccine regulation and quality management system has been operating steadily and effectively, and the regulatory work has been carried out orderly and in accordance with regulations.
The meeting stressed that the construction of the vaccine regulation and quality management system should be carried out in a profound and solid manner. First, efforts should be made to complete the vaccine NRA Institutional Development Plan (IDP) and rectify problems found during the internal review within the time limit and in line with quality requirements. Second, it is important to make further improvements by integrating quality management with regulatory work to improve the operation efficiency of the system. Third, mutual learning and exchanges should be promoted to guide the quality management system at all levels to gradually move from standardized construction to standardized operation, so as to facilitate effective coordination between regulatory work and quality management.
The meeting highlighted that the drug regulation and quality management system should be well-planned. Noting that based on the vaccine regulation and quality management system, the experience and well-received practices should be gradually promoted across all aspects of drug regulation and that the quality management concept should be implemented in every step of drug regulation.
The meeting also called for greater efforts to thoroughly implement the guiding principles of the 20th National Congress of the Communist Party of China, advance the development and operation of the regulation and quality management system, strengthen drug safety regulation, improve the efficiency of drug regulation, promote the modernization of the drug regulatory system and regulatory capacity through quality management, and to drive the high-quality development of the drug industry in a bid to contribute to the Chinese modernization of drug regulation.