The National Medical Products Administration (NMPA) held a meeting on July 20 to examine the construction of the vaccine regulatory quality management system and plan for the internal review of the system. Chen Shifei, NMPA Deputy Commissioner, attended and addressed the meeting.

The NMPA holds a meeting on July 20 on the review of vaccine regulatory quality management system. [Photo/nmpa.gov.cn]

Establishment of the vaccine regulatory quality management system is a basic requirement for the evaluation of the vaccine national regulatory system and is an important means to standardize the national vaccine regulation. The meeting praised the achievements that have been made in the construction of vaccine regulatory quality management system. 

In over a year, the NMPA has formulated documents for vaccine regulatory quality management, carried out risk management and conducted surveys on satisfaction of people for whom the administration provides service. The vaccine regulatory quality management system has come into preliminary and effective operation.

The NMPA has also guided drug regulatory departments at all levels to establish the vaccine regulatory quality management system and promote the establishment of a coordinated national vaccine regulatory quality management system.

The vitality of the quality management system lies in its operation. Risk assessment, internal review and management evaluation of the quality management system is essential to ensuring the effective operation of the system. The meeting stressed that internal review of the system should be fully implemented. Efforts should be made to evaluate the actual effects of risk assessment in the early stage through internal review and to make full preparations for management evaluation.

According to the meeting, it is necessary to take the internal audit as an important opportunity to boost the deployment and learning of the vaccine regulatory quality management system so as to ensure the orderly and effective operation of the system.

Five teams with a total of 25 reviewers are set up to carry out the internal review.

The internal review involves 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, as well as 18 divisions under these departments. The review covers the formulation and release of vaccine provisions and normative documents, management of vaccine registration and clinical trials, vaccine post-marketing regulation, and regulatory support.

Multiple methods, including material review, on-site Q&A and on-site audit, will be applied. The review will begin on July 20 and end on July 30.

Participants of the meeting included personnel from NMPA's relevant departments, relevant personnel from the office of vaccine regulatory quality management system and all the reviewers.