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

Violeta Getova-Kolarova, Ilko Getov

Abstract

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. 


Keywords

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

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References

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, https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2004:136:0001:0033:en:PDF

Гетова В. Негативно становище на ЕМА – поглед върху процедурите по разрешение за употреба завършили с отказ в периода 2018-2019 г. Годишник по болнична фармация, 2020; 6(1), с. 11-17. https://doi.org/10.14748/ahp.v6i1.7157

Гетова В., Гетов И. Анализ на процедурите по разрешение за употреба с негативно становище 2020-2021 г. - как ЕМА отговори на терапевтичните предизвикателства в условията на пандемия от Covid-19, Годишник по болнична фармация. 2021; 7(1):13-19. https://doi.org/10.14748/ahp.v7i1.8068

Сотирова Й., Исаев С., Григоров Е. Възможности за провеждане на лечение с неразрешени лекарствени продукти в България, Годишник по болнична фармация, 2020;6(1):49-57. https://doi.org/10.14748/ahp.v6i1.7162

Amaouche N., Salomé H. C., Collignon O., Santos M. R., Ziogas C. Marketing authorisation applications submitted to the European Medicines Agency by small and medium-sized enterprises: an analysis of major objections and their impact on outcomes, Drug Discovery Today. 2018;23(10):1801-1805. https://doi.org/10.1016/j.drudis.2018.06.018.

Garsen, M., Steenhof, M. & Zwiers, A. A Decade of Marketing Authorization Applications of Anticancer Drugs in the European Union: An Analysis of Procedural Timelines. Ther Innov Regul Sci. 2021;633–642. https://doi.org/10.1007/s43441-021-00260-5

Martinalbo J., Bowen D., Camarero J., Chapelin M., Démolis P., Foggi P., Jonsson B., Llinares J., Moreau A., O'Connor D., Oliveira J., Vamvakas S., Pignatti F. Early market access of cancer drugs in the EU. Ann Oncol. 2016;27(1):96-105. Epub 2015 Oct 20. PMID: 26487583. https://doi.org/10.1093/annonc/mdv506.

Human medicines highlights 2021, https://www.ema.europa.eu/en/documents/report/human-medicines-highlights-2021_en.pdf

Refusal of the marketing authorisation for Aduhelm (aducanumab) EMA/112932/2022; https://www.ema.europa.eu/en/documents/medicine-qa/questions-answers-refusal-marketing-authorisation-aduhelm-aducanumab_en.pdf

Assessment report Ipique EMA/CHMP/180855/2022; 24 February 2022; https://www.ema.europa.eu/en/documents/assessment-report/ipique-epar-refusal-public-assessment-report_en.pdf

Assessment report Raylumis EMA/CHMP/556162/2021; 16 September 2021 https://www.ema.europa.eu/en/documents/assessment-report/raylumis-epar-refusal-public-assessment-report_en.pdf

Refusal of marketing authorization for Flynpovi, EMA/350828/2021 Rev. 1, https://www.ema.europa.eu/en/documents/smop-initial/questions-answers-refusal-marketing-authorisation-flynpovi-eflornithine/sulindac_en.pdf

Refusal of marketing authorization for Nouryant, EMA/404283/2021 Rev. 1, https://www.ema.europa.eu/en/documents/smop-initial/questions-answers-refusal-marketing-authorisation-nouryant-istradefylline_en.pdf

CHMP meeting highlights 2022, https://www.ema.europa.eu/en/committees/chmp/chmp-agendas-minutes-highlights

Refusal of marketing authorization for Hervelous; EMA 373753/2022 Rev. 1, EMA/H/C/005066 https://www.ema.europa.eu/en/documents/smop-initial/questions-answers-refusal-marketing-authorisation-hervelous-trastuzumab_en.pdf

Refusal of marketing authorization for Tuznue; EMA 366869/2022 Rev. 1, EMA/H/C/005066 https://www.ema.europa.eu/en/documents/smop-initial/questions-answers-refusal-change-marketing-authorisation-tuznue-trastuzumab_en.pdf

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




DOI: http://dx.doi.org/10.14748/ahp.v8i1.8582

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