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Role of eurasian economic commission in global clinical research and development

Author: 
Dr. Marina Komaroff
Subject Area: 
Health Sciences
Abstract: 

Background: Eurasian Economic Commission (EEC) was established in 2014 by Belarus, Kazakhstan, Russia, Armenia and Kyrgyzstanas a regulatory body of the Eurasian Economic Union (EAEU).EEC’s goal is to unite participated states under the uniformed regulations for the development, registration, production, and circulation of medical products.In 2016, the EEC created and released about 40 regulatory documents for medical drugs and devices and half are currently under revision. Rationale: The United States Food and Drug Administration (FDA), European Medicines Agency (EMA), Japanese Ministry of Health, Labor and Welfare (MHLW) and other international organizations constantly revise and update regulations and guidelines for development and registration of medical products. They admit that existing process is long, expensive, and contains multiple gaps that motivate to look aggressively for novel approaches in clinical research. Therefore, it is an interest to understand if recently formed EEC has developed innovative ways to build pharmaceutical industry in the EAEU. Objective: The aim of this paper is to understandif EEC’sprogression in building domestic pharmaceutical industry carries scientific values and novel approaches that can be sharedwith theother global players in the field of clinical research. Method: To review and evaluate EEC’s signed-off regulationsin terms of consistency with theworld-wide standards, and/or possession of innovative scientific approaches. Conclusion: The developed by EEC regulations are consistent with international industry in terms ofconduct and supervision of clinical trials. There is little progress regarding the discovery and development of new medical products, possiblybecause of lack of scientific and analytical background underlying committed clinical research. There is no intention ofaligning with the global movement towards developing innovative approaches in clinical research.The author proposed some thoughts about alternativesthat could have been considered to build up anadvanced pharmaceutical industryin the EAEU.

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