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

Abstract

Background: China has implemented the priority review (PR) program and flexible registration requirements for new drugs with significant clinical value since 2016 to accelerate drug access. We aim to explore the impact of the reform efforts on the drug access gap between China and the US.

Methods: We collected data on the imported new drug approvals that were licensed in China between 2007 and 2023, and measured their launch delays as compared to the US. Difference-in-difference models were used to compare the launch delays of PR approvals and non-PR approvals before and after the implementation of the PR. Propensity score matching was used to construct the imputed PR and non-PR approvals in the pre-PR period.

Results: A total of 410 imported approvals were licensed in China in 2007-2023. Most approvals (316[77.1%]) were licensed after the PR was implemented, of which 189[59.8%] received the PR designation. The difference-in-difference models found that the PR program reduced drug launch delay by 1157.0 days (robust standard error, 571.0; P<0.05) and reduced drug submission delay by 1037.3 days (robust standard error, 520.8; P<0.05). The PR identified drugs with high clinical value and informed flexible registration requirements for them, which accelerated drug submission and market entry.

Conclusions: Our findings proved the importance of value-based prioritization of new drugs and flexibility in the statutory evidentiary standard in the drug approval process. Further efforts from the drug agency are needed to leverage the regulatory flexibility to provide fast market entry of new drugs without compromising their quality.