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China’s vaccine regulator reaches new WHO rank

WHO confirmed the country’s attainment of Maturity Level three (ML3)—the third of four levels in the WHO’s classification

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The World Health Organization (WHO) yesterday ranked China’s vaccine regulatory system at a functional level of maturity according to WHO’s global classification system for national medical products regulatory authorities. 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, WHO said in a statement.

According to the statement, WHO confirmed the country’s attainment of Maturity Level three (ML3)—the third of four levels in the WHO’s classification. Maturity level four (ML4) is the highest.

WHO performed an assessment of the Chinese National Regulatory Authority (NRA) in April 2014, based on the then WHO vaccines assessment tool indicators and focussing 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, the statement concluded.

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