NMPA holds management review meeting on vaccine regulatory quality management system

Jun. 28, 2021

Updated: 2021-06-25

The National Medical Products Administration (NMPA) held a management review meeting on the vaccine regulatory quality management system on June 15, to summarize the construction and operation of the system, evaluate its appropriateness, effectiveness and adequacy, and make arrangements for the key tasks of the next stage of its construction.

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NMPA Commissioner Jiao Hong addressed the conference. NMPA Deputy Commissioner Chen Shifei delivered a work report.

The establishment of a vaccine regulatory quality management system is a basic requirement for the National Regulatory Authority (NRA) assessment of vaccines, an important measure in terms of standardizing vaccine regulation, a key step in fully implementing the State Council's instructions on comprehensively strengthening drug regulatory capability building, and also a significant path to modernizing the vaccine regulatory system and regulatory capabilities.

The meeting reviewed the construction and operation of the vaccine regulatory quality management system.

During the system's construction, the NMPA compiled and issued quality management manuals, and integrated quality management into its supervision work to ensure that the quality requirements are operable and implemented. A total of 42 documents on vaccine regulation procedures were compiled, published and implemented, covering basically all vaccine regulatory activities, making sure that the duty of vaccine regulation is specified and the operation standardized, so as to guarantee the consistency of regulation and decision-making. The NMPA also listed the responsibilities of vaccine regulatory authorities and documents of vaccine regulatory quality management for provincial medical products administrations in order to guide the work of drug regulators at all levels.

During the system's operation, the NMPA delivered quality management measures such as risk management, internal reviews and service target satisfaction surveys, worked out countermeasures for the problems found and completed rectification work. NMPA department officials reported on the rectification work and internal reviews at the meeting.

Meanwhile, the NMPA enhanced the guidance and supervision of establishing the system at its affiliated institutions and all provincial-level medical products administrations. At present, a coordinated and unified national vaccine regulatory quality management system has been initially formed with vaccine regulatory quality management system established at the NMPA, its affiliated institutions and 31 provincial-level medical products administrations.

The meeting noted the achievements of the vaccine regulatory quality management system. According to Jiao, the vaccine regulatory quality management system is appropriate, adequate and effective. Through the establishment and operation of the system, rules and regulations have been reinforced to standardize supervision, laying a good foundation for the World Health Organization's vaccine NRA assessment. For more than a year, the NMPA on one hand has devoted itself to COVID-19 prevention and control, and on the other hand has kept developing the system. In the fight against the epidemic, regulatory work has been steadily carried out in an orderly and effective manner, which proves the significance of the system.

The meeting stressed that it is necessary to fully understand the system's role of guidance and demonstration in terms of standardizing the overall drug regulatory work. Developing the system should be regarded as building a foundation for long-term benefits, and great importance should be attached to the rectification of problems found in developing the system, so as to ensure the continuous standardization of regulatory work through the effective operation and improvement of the system.

Jiao said that the focus of the next stage of the system is to accelerate the overall coordination and effective interaction between the systems of the national, provincial, municipal and county-level medical products administrations, so as to integrate every progress into a coordinated and unified national vaccine regulatory quality management system. Relevant NMPA-affiliated institutions and provincial-level medical products administrations should establish and effectively operate their own vaccine regulatory quality management systems and form a smooth connection mechanism to ensure that the national vaccine regulatory quality management system is united and works as one team.