The Chinese National Regulatory Authority (NRA) is now classed as being at a functional level of maturity according to the WHO’s global classification system for national regulatory authorities for medical products. This means that China has a stable, well-functioning and integrated regulatory system to ensure the quality, safety, and effectiveness of vaccines that are manufactured, imported or distributed in the country.
- The World Health Organization undertook a review of the Chinese NRA back in April 2014 based on the WHO vaccines assessment tool indicators at that time. The WHO undertook subsequent benchmarking activities in 2019 and 2021 indicating recommendations for actions.
- Further to those assessments, a WHO expert team conducted a formal benchmarking of the NRA (represented by the National Medical Products Administration) in July 2022 using the most recent and more comprehensive assessment tool: the WHO Global Benchmarking Tool.
- As the National Medical Products Administration (NMPA) had taken into consideration and addressed the recommendations made by the WHO as result of the assessments already undertaken in 2014, 2019 and 2021, the WHO was able to confirm China’s Maturity Level 3 (ML3) achievement for the regulation of vaccines in China.
- 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.
- WHO Regional Director for the Western Pacific, Dr Takeshi Kasai, congratulated the People’s Republic of China for achieving ML3 for their vaccine regulation system. It is recognized as 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. Dr Takeshi further recommended the NMPA and respective institutions to scale up their effort towards regulating medicines and other medical products to achieve the highest level of maturity which is level 4.
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