China National Regulatory Authority (NRA) for vaccines receives WHO endorsement

News release

China’s National Regulatory Authority (NRA) for vaccines, the China Food and Drug Administration (CFDA), has been evaluated by WHO experts, and assessed as meeting or exceeding all World Health Organization (WHO) standards, WHO Director-General Margaret Chan announced today.

“We are delighted to announce the very strong results of WHO’s evaluation of China’s NRA for vaccines. This is a significant achievement for the CFDA and its affiliated institutions,” Dr Chan said.

“As a result of this evaluation, WHO is confident in the quality, safety and effectiveness of vaccines that are made in China.”

“This is a great result for the regulators, but an even better result for the children of China, because it confirms that Chinese vaccines are quality assured to international standards of production, safety, and effectiveness,” explained Dr Chan.

Vaccines are among the most effective and cost effective tools available to prevent suffering and death from infectious diseases, especially among children. However, vaccine production is a complex process necessitating the highest standards of safety and quality.

Government regulatory agencies have oversight responsibility for ensuring that vaccines are safe and effective, and are produced following the internationally-recognized Good Manufacturing Practices. This critically important role is carried out by the CFDA and its affiliated institutions.

The WHO periodically evaluates countries’ NRAs against international standards to determine the quality of regulatory oversight.

In April of this year, a team of experts from WHO evaluated the China NRA for vaccines, and found that it has met or exceeded all of the WHO criteria for functioning at international standards of excellence.

This evaluation follows by three years the first successful evaluation, which was announced in 2011.

“This second successful evaluation demonstrates the maturity of China’s NRA for vaccines. We congratulate the CFDA and its affiliated institutions on this very important achievement,” said Dr Bernhard Schwartländer, WHO Representative in China.

“China’s NRA passing this re-assessment means the vaccine regulatory capacity of China has met the basic requirements of WHO. We must continuously work hard to address the issues arising in the course of management, set our targets aiming at the international cutting-edge standards, and proactively motivate ourselves to keep moving forward. We will study in-depth the precious comments and suggestions from WHO, develop and implement a reasonable workplan based on both international experience and Chinese context, further improve and strengthen the vaccine regulatory system of China, and continuously promote the healthy development of the vaccine industry,” said Zhang Yong, Minister of CFDA.

With an NRA assessed as meeting WHO standards, vaccine manufacturers in China are eligible to apply for prequalification of specific products. This is important because WHO prequalification, a guarantee that a specific products are made to international standards of quality, safety and efficacy, is required for procurement of vaccines by UNICEF with funding from the Global Alliance for Vaccines and Immunization (GAVI).

Last year, WHO announced the successful prequalification of a vaccine for Japanese Encephalitis developed in China.

“Today’s announcement gives all of us confidence in the safety and effectiveness of vaccines made and used in China – to the great benefit of the children of China, and the world,” Dr Chan concluded.

About the World Health Organization

WHO is the directing and coordinating authority for health within the United Nations system. It is responsible for providing leadership on global health matters, shaping the health research agenda, setting norms and standards, articulating evidence-based policy options, providing technical support to countries and monitoring and assessing health trends.

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