Clinical evidence deficiencies drive CHMP negative opinions and pre-opinion withdrawals in the EU centralized procedure (2021–2025)

IntroductionMarket authorization applications that do not obtain authorization after CHMP review, whether through a formal negative opinion or pre-opinion withdrawal, remain poorly characterized at a systems level, despite substantial strategic, and commercial implications for applicants, and the br...

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Detalhes bibliográficos

Principais autores:	Iris Pennings, Prerona Boruah, Alex Zwiers
Formato:	Artigo
Idioma:	Inglês
Publicado em:	Frontiers Media S.A. 2026-07-01
coleção:	Frontiers in Medicine
Assuntos:	centralized procedure CHMP clinical efficacy marketing authorization application negative opinion regulatory strategy
Acesso em linha:	https://www.frontiersin.org/articles/10.3389/fmed.2026.1875064/full
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