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Annual for Hospital Pharmacy

Marketing authorization procedures with negative opinion from EMA—tendencies and novelties in 2021–2022

Violeta Getova-Kolarova, Ilko Getov


Every year the European Medicines Agency conducts scientific assessment of numerous applications for marketing authorization of new medicines via centralized procedure. Relatively few of them are being rejected yearly because of insufficient evidence of quality, efficacy or safety. The current study analyzes the period July 2021–June 2022 in terms of the most frequent reasons for rejection of marketing authorization applications. For the same period, we take a look at the specific procedures for granting accelerated market access laid in the European pharmaceutical regulation. Their role in treatment of unmet medical needs and threats to global health status is pointed out. 


marketing authorization, accelerated access, clinical efficacy, benefit/risk ratio

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Regulation (EC) no 726/2004 of the European parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency,

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Human medicines highlights 2021,

Refusal of the marketing authorisation for Aduhelm (aducanumab) EMA/112932/2022;

Assessment report Ipique EMA/CHMP/180855/2022; 24 February 2022;

Assessment report Raylumis EMA/CHMP/556162/2021; 16 September 2021

Refusal of marketing authorization for Flynpovi, EMA/350828/2021 Rev. 1,

Refusal of marketing authorization for Nouryant, EMA/404283/2021 Rev. 1,

CHMP meeting highlights 2022,

Refusal of marketing authorization for Hervelous; EMA 373753/2022 Rev. 1, EMA/H/C/005066

Refusal of marketing authorization for Tuznue; EMA 366869/2022 Rev. 1, EMA/H/C/005066

Сербезова А., Маджаров В., Георгиев С. Регулаторни подходи за разрешаване на лекарства за употреба, Теа Дизайн, 2021

Цеков И., Роля на специфичните процедури за разрешение за употреба за ранен достъп и механизмите за ранен диалог за осигуряване на достъп до пазара, дисертационен труд за придобиване на ОНС „доктор“, МУ-София, 2022



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