China's vaccine regulatory system passes WHO assessment

The World Health Organization (WHO) announced on Aug 23 that China had passed the assessment of the National Regulatory Authority (NRA) for vaccines.

The WHO's assessment of the NRA for vaccines is an important measure and effective means to evaluate the national vaccine regulatory capacity. It is a world-recognized international assessment that can scientifically and comprehensively evaluate the level of vaccine regulation in a country. China's vaccine regulatory system has passed the assessment twice, in 2011 and 2014, and received a new round of comprehensive assessment in July 2022 after the WHO upgraded its evaluation standards. The assessment indicators have been greatly increased, the contents more comprehensive and the standards stricter.

The fact that China's vaccine regulatory system has passed the WHO's latest assessment means the country has a stable, well-functioning and integrated regulatory system, which can ensure that vaccines manufactured, imported and distributed in China are of a controllable quality, are safe and effective. It is also an important foundation for the export of Chinese vaccines.

The WHO takes passing the NRA assessment for vaccines as the premise for purchasing vaccine products in a country, which means that, only when a national regulatory system passes the assessment can enterprises in that country apply for the WHO’s vaccine product prequalification and be listed in the procurement list of the United Nations and other international organizations. In addition, the assessment is also an important reference for other countries to register and purchase vaccine products.

Since China first passed the assessment, several vaccines, including the domestic live attenuated encephalitis B vaccine, live attenuated poliomyelitis type I and III vaccine, and inactivated hepatitis A vaccine, have passed the WHO's vaccine prequalification and entered the international procurement list. They have been purchased by the United Nations International Children's Emergency Fund, the Global Alliance for Vaccines and Immunization, and other international institutions. Relevant products have been exported to dozens of countries and regions. Since the outbreak of COVID-19, three Chinese COVID-19 vaccines have been included in the WHO emergency use listing to help in the global fight against the virus.

China's latest successful WHO assessment shows that the country has seen improvements in its vaccine regulatory capacity and level, with international standards as a benchmark. It also shows that China can ensure that its vaccine products are safe, effective and controllable in quality, so as to better protect people's health. At the same time, it creates favorable conditions for the export of Chinese vaccines and China's contribution to the development of global public health undertakings. China can play a more active role in global vaccine supply, and make more contributions to promoting future vaccine accessibility and affordability around the world, especially in developing countries.