WHO recognizes quality, capability of China's vaccine regulatory system

China's vaccine regulatory system has recently obtained a high-level assessment from the World Health Organization that recognizes the nation's capability to ensure the quality, safety and effectiveness of vaccines.

Experts and officials said the new evaluation could facilitate wider adoption of Chinese-developed vaccines across the globe and contribute to boosting vaccine access and affordability in developing countries.

In a statement released on Tuesday, the WHO said that China's vaccine regulatory system is ranked at a functional level of maturity, or the second-highest level of a four-tier system, based on its latest 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," it said.

Jiao Hong, director of the National Medical Products Administration, said that the new status is solid proof of the robust and healthy functioning of China's vaccine regulatory system.

This also proves that "it is capable of making more contributions to the global supply by providing safe, effective, affordable and accessible vaccine products of high quality", she said.

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

Since 2006, the WHO evaluation of national regulatory agencies has become a prerequisite for applying for the organization's approval of medical products, which would pave the way for procurement led by international agencies.

China passed similar assessments in 2011 and 2014, and has successfully achieved emergency authorization from the WHO for several domestic vaccines for Japanese encephalitis, polio and hepatitis A.

"These domestic vaccines have been exported to dozens of countries and regions," the administration said in a written reply to China Daily.

"Since the COVID-19 pandemic broke out, three Chinese-developed vaccines have also been added to the WHO's emergency use listing, playing a great role in the global fight against the disease."

The WHO began overhauling its evaluation tools for national regulatory agencies in 2015.

It published the final version, known as the Global Benchmarking Tool, in 2021, involving more metrics and more comprehensive and rigorous standards.

"China's continued work in taking assessment from the WHO reflects that we are striving to align with international standards, improve our supervision capability and ensure the safety and quality of vaccines," the administration said.

Zheng Zhijie, director of the China Country Office of the Bill & Melinda Gates Foundation and a public health expert, said that China has been a key supplier of medical products for COVID-19 globally, accounting for more than half of all nucleic acid testing kits granted emergency authorization from the WHO, and providing more than 2.1 billion domestically-produced vaccines overseas.

"Throughout the process, the National Medical Products Administration has played a key role in ensuring the timely supply of essential medical products against COVID-19－especially COVID-19 vaccines and test kits－for use domestically and abroad," he said.

With the new assessment, Zheng said China's increasing vaccine R&D and production capabilities mean that it can play a bigger role in strengthening immunization equity around the world.