Regulatory efforts to address the access gap for foreign new drugs in China: the priority review program and related policies

Table 1 Introduction of the priority review and its related policies

	Priority review		Adoption of overseas trials	Conditional approval
Timeline	2016—2019	2020 and later	2018 and later	2017 and later
Scope	New drugs with high clinical value for the treatment of: (1) cancers; (2) rare conditions; (3) major infectious diseases of HIV, viral hepatitis and tuberculosis; (4) pediatric populations.	New drugs with high clinical value and: (1) addressing urgent medical needs; (2) providing new dosage or new formulation for pediatric populations; (3) treating rare conditions or major infectious diseases; (4) granted with conditional approval; (5) granted with breakthrough therapy.	Drugs with high clinical value for the treatment of: (1) life-threatening diseases; (2) rare conditions; (3) pediatric diseases with unmet medical needs.	New drugs intended to treat serious or life-threatening ailments based on surrogate end points or intermediate results
Benefit	1. communication with the agency before application 2. prior review and evaluation 3. conditional approval based on preliminary evidence for life-threatening diseases 4. exemption of domestic trial for rare conditions	1. communication with the agency before application 2. prior and fast review (130 days)	1. approval based on overseas clinical data, if there is no ethnic sensitivity 2. conditional approval based on overseas clinical data, if ethnic sensitivity exists or remains unknown	1. early approval with the commitment to complete confirmatory trials after marketing 2. priority review

In Feb 2016, the PR was created as a comprehensive program to lead the reform in the Chinese drug approval system. In 2016-2019, the PR provided more benefits than a fast review process: before submitting an application, drug sponsors could apply for communication with NMPA and request a reduction or exemption of domestic clinical trials, or conditional approval based on early-stage evidence. Since 2020, the benefits of flexible registration requirements have been removed from the PR. However, the PR drugs may still apply for conditional approval or exemption of domestic trials, provided that the requisite conditions are met. PR, priority review. NMPA, National Medical Product Administration.

ISSN: 2397-0642