Clinical Development, Regulatory, and Reimbursement Review Duration of New Drugs in the US and European Countries

作者：Simon Hediger, Camille E.G. Glaus, Stacie B. Dusetzina, Ulrich‐Peter Rohr, Thomas J. Hwang, Kerstin Noelle Vokinger · 发表于：JAMA Health Forum · 年份：2026 · DOI：10.1001/jamahealthforum.2026.2332 · 研究领域：Pharmaceutical Economics and Policy、Health Systems, Economic Evaluations, Quality of Life、Biosimilars and Bioanalytical Methods

Importance: Rapid access to new drugs is of interest to patients and society. Objective: To analyze duration for clinical development, regulatory review, and reimbursement review of new drugs and assess whether these durations changed over the past decade in the US and European countries (Germany, France, and Switzerland). Design, Setting, and Participants: In this cross-sectional study, databases of the US Food and Drug Administration, the European Medicines Agency, and the Swiss Agency for Therapeutic Products were used to identify all new drugs approved from 2014 to 2024, investigational new drug application dates, submission dates, and approval pathways. Reimbursement dates were extracted from Medicare (US), Ministry of Health and Prevention (France), Federal Joint Committee (Germany), Federal Office of Public Health (Switzerland). Main Outcomes and Measures: Kaplan-Meier estimates were applied to calculate the median time for clinical development, regulatory review, and reimbursement review. Results: This study included 519 drugs in the US, 412 in France, 412 in Germany, and 395 in Switzerland. Median total duration from clinical trial initiation until reimbursement was 9.3 (95% CI, 9.0-9.8) years in the US, 11.1 (95% CI, 10.2-12.0) years in France, 8.9 (95% CI, 8.3-9.5) years in Germany, and 9.8 (95% CI, 9.6-10.5) years in Switzerland. Median total duration from clinical trial initiation until reimbursement increased in the US from 9.0 (95% CI, 8.43-9.90) years in the f...