Chinese national regulatory authority meets international standards
1 March 2011 - A WHO-led team concluded today, at the end of a comprehensive review by experts from 6 countries, that the national regulatory authority of China, the State Food and Drug Administration (SFDA), and affiliated institutions, meet WHO indicators for a functional vaccine regulatory system.
The result means that the SFDA is compliant in all areas required to provide regulatory oversight of vaccines: 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.
Today's conclusion is the culmination of 19 months of intensive effort by the SFDA to implement a roadmap — developed by national experts, with continuous advice from WHO — to strengthen capacity for regulation of vaccines.
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. It is expected that vaccines from China 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.