摘要：
Objective To provide reference for improving the accelerated review and approval policies of drug registration in China. Methods A comparison was made to analyze the accelerated review and approval policies of drug registration between China and the United States. A case analysis of Osimertinib and Almonertinib was taken to study the application effect of the accelerated review and approval policies in China and the United States. Results and Conclusion The combination program of breakthrough therapy and accelerated approval took only two and a half years to make Osimertinib the fastest-marketed anti-tumor drug in the history of the FDA. Meanwhile, Osimertinib was the fastest-approved imported drug in China with the priority review and approval program. It took Almonertinib two years and ten months to obtain marketing approval using the programs of priority review and approval and conditional approval, suggesting that the acceleration effect was also remarkable. The accelerated review and approval policies in the United States and China can speed up the marketing approval of clinically urgent drugs with significant efficacy.
Wang Shufang, Tian Lijuan, Yao Wei.
Study of Accelerated Review and Approval Policies for Drug Registration between China and the United States Based on Comparative Case Analysis of Osimertinib and Almonertinib
[J]. 亚洲社会药学, 2026, 21(1): 29-35.
Wang Shufang, Tian Lijuan, Yao Wei. Study of Accelerated Review and Approval Policies for Drug Registration between China and the United States Based on Comparative Case Analysis of Osimertinib and Almonertinib[J]. Asian Journal of Social Pharmacy, 2026, 21(1): 29-35.
