Government and Policy
SFDA gets WHO approval for vaccine regulation
By Shan Juan (chinadaily.com.cn)
Updated: 2011-03-01 17:40
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China's State Food and Drug Administration (SFDA) has been shown to comply with international standards for vaccine regulation.
This could eventually open the door for vaccines produced in China to be supplied through United Nations agencies to developing countries, said a press release issued by the World Health Organization's Beijing Office Tuesday.
With a regulatory system for vaccines documented to comply with international standards, vaccine manufacturers in China are now eligible to apply for WHO prequalification of specific products. Prequalification, which is a guarantee that a specific vaccine meets international standards of quality, safety and efficacy, is a prerequisite for manufacturers to supply to countries through United Nations procuring agencies. Each application for prequalification of a specific product is independently evaluated by WHO.
"We wholeheartedly congratulate the State Food and Drug Administration on this important achievement," said WHO China Representative Dr Michael O'Leary. "It is a validation of the capability of the Chinese regulatory authority to ensure that vaccines released onto the market are of assured quality."