China's vaccine regulator reaches new WHO rank for safety, quality, efficacy, lays foundation for vaccine exports

August 23, 2022 - The World Health Organization (WHO) ranked China's vaccine regulatory system at a functional level of maturity according to the WHO's global classification system for national medical product regulatory authorities, which experts said means that China has a stable, well-functioning and integrated regulatory system to ensure the quality, safety and efficacy of vaccines that are manufactured, imported or distributed in the country, and lays an important foundation for Chinese vaccines to be imported by other countries. 


The WHO confirmed the Chinese National Regulatory Authority's (NRA) attainment of maturity level three (ML3) - the third of four levels in the WHO's classification. Maturity level four (ML4) is the highest. 


“Congratulations to the People’s Republic of China for achieving maturity level 3 for their vaccine regulation system. This is a significant step for the global supply of vaccines because of China’s role as a manufacturer, as well as being an important step for public health in China. It will bring more quality-assured vaccines to save lives around the world. My appreciation goes to the National Medical Products Administration, affiliated national institutions and provincial authorities who demonstrated the level of performance that meets the global standard in assuring the quality, safety and efficacy of vaccines being available from China. Using the momentum of this achievement, I do encourage NMPA and respective institutions to scale up the effort towards regulating medicines and other medical products to move up towards the highest level of maturity,” said Dr Takeshi Kasai, WHO Regional Director for the Western Pacific.


“I believe this achievement will further prompt other countries in the Western Pacific Region to invest in strengthening regulatory systems to ensure the availability and access to quality, safe, effective, and affordable medical products to their peoples. It should also serve to promote confidence, trust, and further reliance on authorities attaining this level of maturity,” said Mariângela Simão, WHO Assistant Director-General for Access to Medicines and Health Products.


“WHO’s conclusion on China’s vaccine regulatory system is solid proof that our system is continuously stable, effective and well-functioning, and it is capable of making more contributions to the global supply by providing safe, effective, affordable and accessible vaccine products with high quality,” said Jiao Hong, Commissioner of the National Medical Products Administration (NMPA), China.


WHO performed an assessment of the Chinese National Regulatory Authority (NRA) in April 2014, based on the then WHO vaccines assessment tool indicators and focusing on the Chinese vaccine regulatory system and performed additional benchmarking activities in 2019 and 2021. As a follow up to these activities, a WHO expert team conducted the formal benchmarking of the Chinese NRA, represented by NMPA, in July 2022 using an updated and more comprehensive assessment tool, the WHO Global Benchmarking Tool. During the benchmarking, WHO noted that the NMPA had considered and addressed recommendations made following the activities in 2014, 2019 and 2021, confirming the country’s ML3 achievement for the regulation of vaccines in China.