Chinese national regulatory authority meets international standards

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...