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Annual for Hospital Pharmacy

Negative Opinion Of The EMA – Overview On Marketing Authorization Procedures Concluded With Rejection In 2018-2019

Violeta Getova

Abstract

Every year the European medicines agency assesses numerous applications for marketing authorization of new medicines. A part of them are rejected most often due to lack of sufficient efficacy data or unacceptable safety profile. For the period 2018-2019 around 5% of the marketing authorization applications via centralized procedure were rejected, including some which do not have approved therapeutic alternatives at the moment. The current study aims at pointing out the priorities EMA follows in the assessment of data and to analyze the reasons which led to rejection of the marketing authorization applications.

Keywords

marketing authorization, centralized procedure, quality, efficacy, safety

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DOI: http://dx.doi.org/10.14748/ahp.v6i1.7157

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