REMEDIUM

1561-59362658-3534

Joint-Stock Company Chicot

1318

10.21518/1561-5936-2018-11-6-20

Original Article

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

Niyazov

R. R.

noemail@neicon.ruVasiliev

A. N.

noemail@neicon.ruGavrishina

E. V.

noemail@neicon.ruDranitsyna

M. A.

noemail@neicon.ruKulichev

D. A.

noemail@neicon.ru

Center for Scientific Advice LLC

11122018

11620

18032022

2018

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.

healthcare needsserious or life-threatening diseasesbreakthrough therapyexpedited accessaccelerated assessmentscientific advicepriority reviewbiomarkerssurrogate endpoints

нужды здравоохранениясерьезные или жизнеугрожающие заболеванияпрорывная терапияускоренная регистрациянаучное консультированиеприоритетная экспертизабиомаркерысуррогатные конечные точки

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