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An Analysis of Regulatory Timing and Outcomes for New Drug Applications Submitted to Swissmedic: Comparison With the US Food and Drug Administration and the European Medicines Agency.

Abstract：

BACKGROUND:This study compared the timing, regulatory marketing authorization decisions, and the final labeling for products submitted to Swissmedic to those submitted to European Medicines Agency (EMA) and the US Food & Drug Administration (FDA). METHODS:The Centre for Innovation in Regulatory Science (CIRS) conducted an analysis of a representative cohort of 63 new molecular entities (NMEs) that were submitted to Swissmedic from 2006 through 2010 and that were also submitted to, and approved by, the EMA centralized procedure and FDA. Parameters considered included the outcome and timing of regulatory marketing authorization decisions and the comparison of each product's Summary of Product Characteristics (SPC) from the 3 agencies. The results were presented at the Swissmedic 10th Anniversary Symposium, "The Challenges of Regulation and Changing Regulations Paradigms," and they form the basis of this article. RESULTS:The median approval times for these NMEs were longer for Swissmedic (480 days) compared with FDA (303 days) and EMA (416 days). However, if an expedited application review procedure (a "priority review" [FDA], "accelerated assessment" [EMA], or "accelerated review" [Swissmedic]) was applied, Swissmedic was faster (207 days) than EMA (300 days) and essentially as fast as FDA (229 days). The main differences were in the nature of the wording of parts of the initial SPC, particularly the "Contraindications" and "Special warnings and precautions" for FDA and "Special warnings and precautions" for EMA. CONCLUSIONS:Results suggest there is no clear evidence that Swissmedic was substantially different in its initial regulatory decisions or SPC recommendations compared with the EMA or FDA.

journal_name

Ther Innov Regul Sci

journal_title

Therapeutic innovation & regulatory science

authors

Dörr P,Wadworth A,Wang T,McAuslane N,Liberti L

doi

10.1177/2168479016655841

subject

Has Abstract

pub_date

2016-11-01 00:00:00

pages

734-742

issue

eissn

2168-4790

issn

2168-4804

journal_volume

pub_type

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An Analysis of Regulatory Timing and Outcomes for New Drug Applications Submitted to Swissmedic: Comparison With the US Food and Drug Administration and the European Medicines Agency.