China Food and Drug body passes WHO evaluation

The World Health Organization said Friday that China's national regulatory authority for vaccines, the China Food and Drug Administration, meets or exceeds all WHO standards.

National regulatory authorities (NRAs) "are national regulatory agencies responsible for ensuring that products released for public distribution (normally pharmaceuticals and biological products, such as vaccines) are evaluated properly and meet international standards of quality and safety," WHO said.

"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 China Food and Drug Administration and its affiliated institutions," the organization said in an announcement on Friday.

NRAs are assessed on seven aspects, including marketing authorization and licensing, surveillance of adverse events following immunization, lot release and regulatory oversight of clinical trials. China's NRA scored high in all seven, the CFDA said on its website on Friday.

China's NRA first passed the evaluation in March 2011, but the evaluation this year had even higher standards, according to the CFDA.

"As a result of this evaluation, WHO is confident in the quality, safety and effectiveness of vaccines that are made in China," said Margaret Chan, director-general of the World Health Organization.

After passing evaluations in 2011, many domestic vaccine makers became eligible to apply for pre-qualification by WHO for their products, and many did so, according to the CFDA.

The pre-qualification is a guarantee that specific products are made to international standards of quality, safety and efficacy, and is required for procurement of vaccines by the United Nations Children's Fund, according to WHO.

In October 2013, a Chinese vaccine maker received pre-qualification for its vaccine for Japanese encephalitis.

The Chinese government is supporting domestic vaccine makers to serve immunization causes not only in China but also other countries by providing highly effective and quality products, in order to contribute its share to the global goal of disease control, said Zhang Yong, minister of the CFDA.

The CFDA will maintain and strengthen its close cooperation with WHO to improve China's NRA, and will communicate with various international organizations on issues occurring in the country's vaccine industry on a long-term basis, he added.

Dr Bernhard Schwartlander, WHO representative in China, said: "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."

"Passing … will improve the public's confidence in the quality of vaccines," added an expert on immunization who declined to be identified.

The recognition will further encourage domestic vaccine products to enter international markets, he added.

WHO will reassess China's NRA in three to five years, as the science of vaccine production is constantly evolving and there is a need to ensure that regulatory processes keep pace with innovation, WHO said told China Daily in an email.