Scientific article
OA Policy
English

A decade comparison of regulatory decision patterns for oncology products to all other non-oncology products among Swissmedic, European Medicines Agency, and US Food and Drug Administration

Published inClinical and translational science, vol. 16, no. 9, p. 1569-1581
Publication date2023-09
First online date2023-07-05
Abstract

Consensus of regulatory decisions on the same Marketing Authorization Application (MAA) are critical for stakeholders. In this context, regulatory decision patterns from the Swissmedic (SMC), the US Food and Drug Administration (FDA), and the European Medicines Agency (EMA) were analyzed for hemato-oncology products (OP) and non-oncology products (NOP). We compared 336 SMC regulatory decisions between 2009 and 2018 on new active substances with the EMA and the FDA for OP (n = 77) and NOP (n = 259) regarding approval rates, consensus, and divergent decisions. For OP MAA, we analyzed the underlying reasons for divergent decisions; for consensus decisions, the similarity and strictness of labeling. For OP, the approval rate for the SMC was 88.4%, the EMA 91.3%, and the FDA 95.7%. For NOP, the SMC had an approval rate of 86.2%, the EMA of 93.8%, and the FDA of 88.8%. The consensus decision rate among agencies was 88.4% for OP and 84.4% for NOP. The main clinical driver for divergent decisions for OP was nonrandomized trial design and low patient numbers. Comparing the approved indication wordings, the highest similarity was between the SMC and the EMA, and lowest for the FDA and the EMA. Investigating label strictness, the FDA numerically had the highest but not-statistically significant number of strict labels. The approval rate stratified by disease area (OP and NOP) differed among the SMC, the EMA, and the FDA. High concordance in regulatory decisions was observed between agencies for OP as well as NOP. Reasons for divergent decisions regarding OP were mainly due to scientific uncertainties. Comparing strictness of indications, numerical but no statistically significant differences were observed between agencies.

Keywords
  • United States
  • Humans
  • United States Food and Drug Administration
  • Drug Approval
  • Uncertainty
  • Europe
Affiliation entities Not a UNIGE publication
Citation (ISO format)
ROHR, Ulrich-P et al. A decade comparison of regulatory decision patterns for oncology products to all other non-oncology products among Swissmedic, European Medicines Agency, and US Food and Drug Administration. In: Clinical and translational science, 2023, vol. 16, n° 9, p. 1569–1581. doi: 10.1111/cts.13567
Main files (1)
Article (Published version)
Identifiers
Journal ISSN1752-8054
75views
28downloads

Technical informations

Creation16/07/2024 12:07:07
First validation05/08/2024 07:14:21
Update05/08/2024 07:14:21
Status update05/08/2024 07:14:21
Last indexation01/11/2024 10:41:08
All rights reserved by Archive ouverte UNIGE and the University of GenevaunigeBlack