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Editorial
. 2020;5(1):e000615.
doi: 10.1136/esmoopen-2019-000615. Epub 2020 Sep 30.

Old drug, new clinical use, no man's land for the indication: an awareness call from European experts

Stefan Rauh  1 , Leonidas Mavroeidis  2 , Panagiotis Ntellas  2 , Ioanna Gazouli  2 , Stefania Gkoura  2 , Alexandra Papadaki  3 , Davide Mauri  2 , Yannis Metaxas  4 , Jean-Yves Douillard  5 , George Pentheroudakis  2
Affiliations
Editorial

Old drug, new clinical use, no man's land for the indication: an awareness call from European experts

Stefan Rauh et al. ESMO Open. 2020.
No abstract available

Keywords: EMA application process; off licence indication; old drug new indication; reimbursement.

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Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
Procedure and timelines for first drug marketing approval by EMA. CHMP, Committee for Medicinal Products for Human Use. Source: ema.europa.eu
Figure 2
Figure 2
A 60-day procedure for variation II amendments. CHMP, Committee for Medicinal Products for Human Use; PRAC, Pharmacovigilance Risk Assessment Committee. Source (downloaded on 22.09.2019): ec.europa.eu https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-2/c_2013_2008/c_2013_2008_pdf/c_2013_2804
Figure 3
Figure 3
EU commission authorisation procedure and timeline for variation II changes after EMA recommendation. CHMP Committee for Medicinal Products for Human Use; DMP Development Medicinal Product; EC European Commission; EMA, European Medicines Agency; EU, European Union;MAH Market Authorization Holder; MS Member State; QRD Quality Review of Documents. MAH, Marketing Authorisation Holder; QRD, Quality Review of Documents, MS, Member State, DMP, Development Medicinal Product, EC, European Commission. Source (downloaded on 22.09.2019): ec.europa.eu https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-2/c_2013_2008/c_2013_2008_pdf/c_2013_2804
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