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

Abstract

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 first period (January 2014-August 2017) to 9.35 (95% CI, 8.75-11.56) years in the most recent period (May 2021-December 2024). In France, the median total duration increased from 9.82 (95% CI, 8.88-11.41) years to 12.18 (95% CI, 10.12-14.78) years. In Switzerland, median total duration increased from 9.42 (95% CI, 8.2-10.17) years to 10.05 (95% CI, 9.39-12.32) years. In Germany, the median total duration decreased from 9.27 (95% CI, 7.67-10.6) years to 8.7 (95% CI, 7.92-9.57) years. Cancer drugs showed a shorter median total duration compared with all drugs, especially in the US and Germany, and less pronounced in Switzerland and France.

Conclusions and relevance: The findings of this study suggest that the overall median duration from clinical development until reimbursement of new drugs showed only minimal variation over time. Given recent efforts to accelerate new drug approvals, future research should evaluate potentially modifiable factors that increase clinical development durations. This could help to better target policies to accelerate access to new drugs, ideally adequately balancing safety with speed.