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

What was the duration of clinical development, regulatory review, and reimbursement review of new drugs over time in the US, France, Germany, and Switzerland? In this cross-sectional study of 519 drugs in the US, 412 in France, 412 in Germany, and 395 in Switzerland, median duration from clinical trial initiation until reimbursement remained stable over time (2014–2024) across all countries, with overall shorter duration for cancer drugs. Despite pressure and policy changes to speed access to new drugs, results of this study suggest that median total duration remained similar over time; drivers should be analyzed to develop targeted policies to accelerate access while also enabling safety.

Corresponding Author: Kerstin Noelle Vokinger, MD, JD, PhD, Academic Chair for Regulation in Law, Medicine and Technology, University of Zurich and ETH Zurich, Ramistrasse 74, 8001 Zurich, Switzerland (lst.vokinger@ius.uzh.ch).

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