Accelerated drug development and approval pathways, designed to expedite the delivery of essential medicines for patients with serious and rare diseases, have been successfully implemented in the United States, Japan and European countries. Since 2015, the Chinese government has enacted a series of policies encompassing such pathways, including the 2015 “Opinions on the Reform of Review and Approval Process for Drugs and Medical Devices,” and the 2020 revision of the “Provisions for Drug Registration” (Supplementary Figure 1). The latter introduced the Accelerated Drug Marketing Registration Procedures (ADMRPs), which encompass “special review pathways” set up by the NMPA to reduce the time from drug development to market, especially for drugs targeting rare diseases or unmet medical needs. These pathways include Priority Review and Approval (PRA), Breakthrough Therapy Drug (BTD), Conditional Approval (CA) and Special Approval (SA). The definition and scopes of application for the four ADMRP pathways are provided in Supplementary Table 1.
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Competing Interests
The authors declare no competing interests.
