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China Food and Drug body passes WHO evaluation

Updated: 2014-07-04

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By Wang Qingyun

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chinadaily.com.cn

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.

A Chinese medical worker vaccinates a kid against measles at a vaccination station in Shanghai, China, 11 September 2010.Photo by IC/ Dong Jun 

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.

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