China press releases

State Food and Drug Administration gets WHO = approval for=20 vaccine regulatory system

01 March=20 2011

BEIJING =E2=80=93 China's State Food and Drug Administration (SFDA) = has been shown to=20 comply with international standards for vaccine regulation. This could=20 eventually open the door for vaccines produced in China to be supplied = through=20 United Nations agencies to developing countries.

Today's announcement is the culmination of nearly two years of = intensive=20 effort by the SFDA to implement a roadmap =E2=80=93 developed by = national experts, with=20 continuous advice from WHO =E2=80=93 on vaccine regulation. The latest = assessment was=20 carried out on 13-17 December 2010. During that visit, WHO experts = reviewed=20 SFDA's performance against indicators for: the overall system framework; = marketing authorization and licensing; post-marketing surveillance, = including=20 for adverse events following immunization; lot release; laboratory = access,=20 regulatory inspections of manufacturing sites and distribution channels; = and=20 authorization and monitoring of clinical trials. In the context of the = review,=20 they visited institutes involved in vaccine regulation in Beijing, = Shanghai,=20 Hebei and Jiangsu.

As part of their efforts, the SFDA adopted a new Good Manufacturing = Practice=20 (GMP) code in early 2011. In line with international standards, the new = code=20 puts in place stricter requirements for vaccine production to ensure = production=20 of vaccines of assured quality. In addition WHO organized training to = improve=20 the skills of staff responsible for inspecting vaccine manufacturing = sites. The=20 government has also strengthened the post-marketing surveillance system, = to=20 enable quick detection and investigation of adverse events following=20 immunization.

"We wholeheartedly congratulate the State Food and Drug = Administration on=20 this important achievement," said WHO China Representative Dr Michael = O'Leary.=20 "It is a validation of the capability of the Chinese regulatory = authority to=20 ensure that vaccines released onto the market are of assured=20 quality."

With a regulatory system for vaccines documented to = comply with=20 international standards, vaccine manufacturers in China are now eligible = to=20 apply for WHO prequalification of specific products. Prequalification, = which is=20 a guarantee that a specific vaccine meets international standards of = quality,=20 safety and efficacy, is a prerequisite for manufacturers to supply to = countries=20 through United Nations procuring agencies. Each application for = prequalification=20 of a specific product is independently evaluated by WHO.

It is expected that vaccines from China (such as the Japanese = encephalitis=20 vaccine) could be prequalified 1-2 years from now. The eventual ability = of=20 United Nations procuring agencies to source vaccines from Chinese = manufacturers=20 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=20 is the first step in a process which should see Chinese vaccine = producers making=20 a significant contribution to meeting the world's vaccine needs in the = near=20 future."

For more information, please contact:

Ms Wang Hongxia
Public Information Assistant
Tel: +86 10 6532=20 7191
Email:

Related programmes:

Expanded = programme on=20 immunization

Print E-mail= =20 Bookmark Feedback =

=C2=A9World Health = Organization=20 Representative Office in China 2006

WHO Representative Office in = China

China press releases

State Food and Drug Administration gets WHO = approval for=20 vaccine regulatory system

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