皇冠体育app

Government and Policy

SFDA gets WHO approval for vaccine regulation

By Shan Juan (chinadaily.com.cn)
Updated: 2011-03-01 17:40

皇冠体育app'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 皇冠体育app 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 皇冠体育app 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 皇冠体育app 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."