China's SFDA draft fast-track drug procedures

China's State Food and Drug Administration has completed a public consultation process for its new fast-track drug registration procedures, according to PharmAsia News. Four categories of drugs are defined under the proposals: active ingredients that are new to the Chinese market but which have been reviewed elsewhere; those that have not previously been approved in China or abroad; treatments for priority diseases, including HIV/AIDS and cancer; and new therapies for previously-untreatable conditions.

Wang Houzhong, a lawyer at the Shanghai Stone law firm, told PharmAsia News that "the current draft of the special approval procedures aims to find a balance between innovation and risk." In exchange for fast-track approval, sponsors of qualifying drugs would have to provide post-approval information to the SFDA covering safety and effectiveness, including analysis of adverse drug reactions for the first five years.