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China's vaccine regulator attains new maturity rank from WHO
Updated 14:48, 24-Aug-2022
CGTN
A medical worker extracts a dose from a vaccine vial. /CFP

A medical worker extracts a dose from a vaccine vial. /CFP

The World Health Organization (WHO) said on Tuesday that China's vaccine regulatory system had attained a new rank of maturity level according to the WHO's global classification system for national medical products' regulatory authorities.

China has attained maturity level three (ML3) – the third of four levels in the WHO's classification, the WHO stated.

"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 WHO mentioned.

The Chinese National Regulatory Authority (NRA) was first assessed by WHO in April 2014, and has been confirmed this year with the agency's global benchmarking tool. 

The assessment sets a crucial foundation for enterprises within the country to apply for pre-qualification in order to be accepted for procurement by UN agencies, which also acts as important reference for other countries when importing vaccines.

Numerous China's domestic-developed vaccines, including those for Japanese encephalitis, paralysis and hepatitis A, have been certified by WHO and are procured by international agencies such as UNICEF and Gavi, the Vaccine Alliance.

WHO has also approved three of China's COVID-19 vaccines for emergency use.

"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 China's National Medical Products Administration (NMPA).

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