The National Medical Products Administration (NMPA) held staff training on the establishment of the vaccine regulatory quality management system on July 1. Experts were invited to explain the World Health Organization's evaluation requirements and quality management standards for the vaccine national regulatory authorities. More than 200 people participated in the training, including leading officials of the NMPA and staff from the administration's various departments and affiliated institutions.

Training on the vaccine regulatory quality management system is held on July 1. [Photo/nmpa.gov.cn]

The training touched on the WHO's basic requirements for vaccine national regulatory authorities, the new version of the WHO's global benchmarking tool, and its nine components of evaluation requirements, including the vaccine national regulatory system, vaccine marketing authorization and lot release.

The training also involved the ISO9000 series of standards, quality, quality management and quality management systems as well as the interrelationship between the parties within the quality management systems and the requirements of the WHO's evaluation tool for the vaccine regulatory quality management system.

In recent years, China's drug regulatory system has been continuously improved. It passed the WHO's assessment for the vaccine national regulatory system in 2011 and 2014, providing regulatory guarantees for Chinese vaccines to go global.

China will face a new round of WHO assessment for the vaccine national regulatory system in March 2021. This round of assessment will use the WHO's latest global benchmarking tool, which sets higher standards for the establishment of the vaccine regulatory quality management system.

The NMPA will take the assessment of the national regulatory system for vaccines as an opportunity to comprehensively push forward construction of a drug regulatory quality management system, continuously improve the national drug regulatory system, enhance implementation of the Four Most Stringent Requirements for Drug Safety and promote the overall regulatory capabilities.