CHINA / SOCIETY
China's vaccine regulator reaches new WHO rank for safety, quality, efficacy, lays foundation for vaccine exports
Published: Aug 23, 2022 10:33 PM Updated: Aug 23, 2022 10:23 PM
A medical worker prepares to administer a dose of COVID-19 vaccine at a temporary vaccination site in Haidian District of Beijing, capital of China, May 20, 2021. Photo:Xinhua

A medical worker prepares to administer a dose of COVID-19 vaccine at a temporary vaccination site in Haidian District of Beijing, capital of China, May 20, 2021. Photo:Xinhua


The World Health Organization (WHO) on Tuesday 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 - on Tuesday. Maturity level four (ML4) is the highest. 

"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," said Dr. Takeshi Kasai, WHO regional director for the Western Pacific.

"The 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 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), according to the WHO's website.

China's vaccine regulator reaching a new WHO rank demonstrates the regulator's supervision ability and high standards that meet international criteria, a Beijing-based immunologist, who required anonymity, told the Global Times. 

He said it not only shows that China's vaccines can better protect its own people's lives, but also lays the foundation for it to go abroad, as such approval is an important indicator for nations to purchase vaccines from other countries. The immunologist said that it can help China make a contribution to global health, especially when COVID-19 is still ravaging many countries. 

As of January this year, China had provided more than 2 billion doses of COVID-19 vaccines to more than 120 countries and international organizations, becoming the biggest COVID-19 vaccine provider worldwide, the People's Daily reported in January.

The Chinese vaccine regulator first passed the WHO evaluation in 2011. The WHO performed an assessment of the NRA in April 2014, based on the WHO's vaccine assessment tool indicators at that time and focusing on the Chinese vaccine regulatory system. It performed additional benchmarking activities in 2019 and 2021.  

Since 2011, several Chinese vaccines, including the meningococcal B (Men-B) vaccine, and the hepatitis A vaccine, have won WHO precertification and been added to international purchase lists. Since the COVID-19 outbreak, three Chinese COVID-19 vaccines have been listed for emergency use.