Table 2.

Expedited programs developed in China.

Review type	Description
Special Review (SR)	A program issued in the 2007 DRR and applicable for new drugs that not yet launched in any countries. With SR designation, the applicants would receive more intensive guidance from the regulatory authority. The SR program was removed from the 2020 DRR.
Priority Review (PR)	A program introduced by the former CFDA in November 2015 and issued in the 2020 DRR. PR applies to primarily new drugs that showing substantial clinical benefits, for urgently needed conditions and diseases such as major infectious diseases and rare diseases, and new or modified drugs for pediatrics. PR designation shortens the NDA review length to 130 working days as stipulated in the 2020 DRR.
Conditional Approval (CA)	A program introduced by the CFDA in December 2017 and issued in the 2020 DRR. CA applies to drugs and medical devices specified for serious life-threatening conditions, significant unmet medical requirements or rare diseases where early or mid-stage clinical data can be used to anticipate clinical benefits. CA designation allowed NMPA to approve drugs based on outstanding early trial results or surrogate endpoints.
Breakthrough Therapy (BT)	A designation issued in the 2020 DRR and applicable to new drugs that are used for the prevention and the treatment of diseases that seriously endanger life or affect the quality of life, for which there is no effective prevention and treatment, or, compared with existing measures of treatment, there is sufficient evidence proving the obvious clinical advantages.

DRR, drug registration regulation; CFDA, China Food and Drug Administration; NMPA, National Medical Product Administration.