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Analysis of marketing authorization procedures with negative opinion 2020-2021 – how EMA handled challenges in drug therapy during Covid-19 pandemic

Violeta Getova, Ilko Getov


Every year the European medicines agency assesses numerous applications for marketing authorization of new medicines with a part of them inevitably being rejected. For the period 2020-July 2021 less than 5% of the marketing authorization applications via centralized procedure were rejected. Along with the regular marketing authorization applications, the Covid-19 pandemic created the need for fast and effective procedures for both development and assessment of documentation but without compromising the high standards for medicines in the EU. The current study aims at pointing out the priorities in the assessment of data, systemizing the reasons leading to rejection and analyzing EMA’s tools used in 2020-July 2021 in order to meet the therapeutic needs of the pandemic.


drug regulation, marketing authorization, conditional marketing authorization, benefit/risk ratio

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