Проблемы прорывной терапии и ускоренной регистрации в России и ЕАЭС

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Ремедиум. 2018; : 6-20

Проблемы прорывной терапии и ускоренной регистрации в России и ЕАЭС

Ниязов Р. Р., Васильев А. Н., Гавришина Е. В., Драницына М. А., Куличев Д. А.

https://doi.org/10.21518/1561-5936-2018-11-6-20

Аннотация

Сроки разработки и вывода на рынок лекарственных препаратов велики, в т. ч. в связи с необходимостью пошагового согласования многих аспектов с государственными органами. За рубежом в целях ускорения вывода на рынок лекарств, удовлетворяющих наиболее насущные нужды здравоохранения, созданы процедуры, позволяющие оптимизировать процессы согласования и принятия решений на основе предварительных данных. В России и ЕАЭС также есть необходимость в скором выводе на рынок лекарств, которые приносили бы пользу пациентам, однако текущие инфраструктурные и регуляторные реалии требуют глубокого осмысления преимуществ и недостатков ускоренных процедур и продуманного подхода к их внедрению. В работе проведен анализ зарубежных регуляторных подходов к обеспечению ускоренного доступа лекарственных препаратов на рынок и рассмотрены существующие препятствия в отечественной системе регулирования и возможные варианты их преодоления.

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Remedium. 2018; : 6-20

Issues of breakthrough therapy and accelerated market authorization in Russia and the EAEU

Niyazov R. R., Vasiliev A. N., Gavrishina E. V., Dranitsyna M. A., Kulichev D. A.

https://doi.org/10.21518/1561-5936-2018-11-6-20

Abstract

The time needed for the development and placing medicinal products on the market is rather long, which, among others, is due to the need for stepwise approval of many different aspects by the regulatory authorities. In other countries, procedures streamlining the approval and decision-making processes based on the preliminary data were instituted to accelerate the market access for medicines satisfying unmet healthcare needs. In Russia and the EAEU, there is also a need in the accelerated market access for the medicinal products, which are beneficial for the patients. However, the current infrastructure and regulatory environment need a great deal of reflection to assess advantages and drawbacks of the accelerated pathways, and a robust approach should be taken. In this paper, the analysis of the foreign regulatory procedures enabling the accelerated access for the medicinal products on the market has been performed, and current impediments within the domestic regulatory framework and the possible ways to overcome thereof have been discussed.

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Проблемы прорывной терапии и ускоренной регистрации в России и ЕАЭС

Аннотация

Issues of breakthrough therapy and accelerated market authorization in Russia and the EAEU

Abstract

События