Institute of Law, University of Zurich, Zurich, Switzerland, and Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts (K.N.V.).
Institute of Law and Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland (M.S.).
Ann Intern Med. 2023 Oct;176(10):1413-1418. doi: 10.7326/M23-0623.
The speed of drug regulatory agencies in the United States and Europe is often a source of discussion. The objective of this research was to assess regulatory review duration of first and supplementary indications approved between 2011 and 2020 in the United States and Europe (European Union [EU] and Switzerland) and differences in submission times between the United States and Europe. Descriptive statistics were applied to review times between the jurisdictions and across the therapeutic areas. A regression analysis was done to estimate the association between approval agency and review times. The primary analysis cohort included 241 drugs approved in the United States, the EU, and Switzerland. Of these, 128 drugs had supplemental indications (331 in total) in the United States and 87 had supplemental indications (206 in total) in the EU. Overall median review duration from submission to approval subtracting the clock stop period was 39 weeks in the United States, 44 weeks in the EU, and 44 weeks in Switzerland. When review times within each drug were compared, the European Medicines Agency took a median of 3.7 weeks (IQR, -6.7 to 14.9 weeks) longer than the U.S. Food and Drug Administration and Swissmedic a median of 0.3 weeks (IQR, -10.6 to 15.3 weeks) longer. Median total review duration for supplemental indications was 26 weeks in the United States and 40 weeks in the EU. Applications were submitted a median of 1.3 and 17.9 weeks later in the EU and Switzerland, respectively, than in the United States. The regression analysis showed small differences in submission times between the United States and the EU (-2.1 weeks [95% CI, -11.7 to 7.6 weeks]) and larger differences between the United States and Switzerland (33.0 weeks [CI, 23.1 to 42.8 weeks]). It would be beneficial for patients if differences in submission times between the United States and Europe continue to be minimized.
美国和欧洲药品监管机构的审批速度常常成为讨论的话题。本研究旨在评估 2011 年至 2020 年间在美国和欧洲（欧盟和瑞士）批准的首次和补充适应证的监管审查时间，并比较美国和欧洲之间的提交时间差异。描述性统计方法用于评估各司法管辖区和各治疗领域的审查时间。采用回归分析估计批准机构与审查时间之间的关联。主要分析队列包括在美国、欧盟和瑞士批准的 241 种药物。其中，128 种药物在美国有补充适应证（总计 331 种），87 种药物在欧盟有补充适应证（总计 206 种）。从提交到批准减去时钟停止期后，美国的总体中位审查时间为 39 周，欧盟为 44 周，瑞士为 44 周。当比较每种药物的审查时间时，欧洲药品管理局的中位审查时间比美国食品药品监督管理局长 3.7 周（IQR，-6.7 至 14.9 周），瑞士药品管理局比美国食品药品监督管理局长 0.3 周（IQR，-10.6 至 15.3 周）。在美国，补充适应证的中位总审查时间为 26 周，在欧盟为 40 周。在欧盟和瑞士提交申请的中位时间分别比在美国晚 1.3 周和 17.9 周。回归分析显示，美国和欧盟之间的提交时间差异较小（-2.1 周[95%CI，-11.7 至 7.6 周]），而美国和瑞士之间的差异较大（33.0 周[CI，23.1 至 42.8 周]）。如果美国和欧洲之间的提交时间差异继续最小化，将有利于患者。
