CFDA outlines priority review pathway

China FDA released guidance on Thursday to implement a priority review pathway to accelerate the development and approval of new drugs with "significant clinical value" as well as generics.

Sponsors can seek priority review of a candidate with significant clinical value if the compound meets one of the following criteria: it has not been marketed in or outside China; its manufacturing is transferred to China; it uses innovative technology or offers “significant treatment advantages;” its patent protection is slated to expire within three years for a clinical trial application or one year for a drug manufacturing application; it’s a “Chinese medicine (including ethnic medicine) with clear clinical positioning in the prevention and treatment of major diseases”; it's a drug candidate included in a major state-sponsored project; or it is in clinical testing or under registration in the U.S. and EU and is produced with the “same production line in China.”...