China's State Food and Drug Administration gets WHO approval for vaccine regulatory system
1 March 2011 - BEIJING - 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.
Today's announcement is the culmination of nearly two years of intensive effort by the SFDA to implement a roadmap – developed by national experts, with continuous advice from WHO – on vaccine regulation. The latest assessment was carried out on 13-17 December 2010. During that visit, WHO experts reviewed SFDA's performance against indicators for: the overall system framework; marketing authorization and licensing; post-marketing surveillance, including for adverse events following immunization; lot release; laboratory access, regulatory inspections of manufacturing sites and distribution channels; and authorization and monitoring of clinical trials. In the context of the review, they visited institutes involved in vaccine regulation in Beijing, Shanghai, Hebei and Jiangsu.
As part of their efforts, the SFDA adopted a new Good Manufacturing Practice (GMP) code in early 2011. In line with international standards, the new code puts in place stricter requirements for vaccine production to ensure production of vaccines of assured quality. In addition WHO organized training to improve the skills of staff responsible for inspecting vaccine manufacturing sites. The government has also strengthened the post-marketing surveillance system, to enable quick detection and investigation of adverse events following immunization.
"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."
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.
It is expected that vaccines from China (such as the Japanese encephalitis vaccine) could be prequalified 1-2 years from now. The eventual ability of United Nations procuring agencies to source vaccines from Chinese manufacturers is expected to have a significant, beneficial impact on global supply of vaccines of assured quality.
"China has a large industry that produces many vaccines at affordable prices," said Dr O'Leary. "Compliance of the SFDA with international standards is the first step in a process which should see Chinese vaccine producers making a significant contribution to meeting the world's vaccine needs in the near future."
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