Uniform rules for registering medicinal products in the Eurasian Economic Union
Zakharochkina E. R., Rayisyan M. G., Bekhorashvili N., Garankina R. Yu., Ryajemov V. V., Simonyan M.
Journal of Pharmaceutical Sciences and Research
Vol.10, Issue5, P. 1045-1047
Опубликовано: 2018
Тип ресурса: Статья
Аннотация:
The pharmaceutical component of the regional and integration cooperation within the Eurasian Economic Union is characterized by the formation of the common market of medicinal products. The unified principles and rules of the medicinal products’ circulation are determined by a considerable number of new legislative and regulatory documents that regulate various types of activities on the pharmaceutical market. Registration is an important stage in the lifecycle of a medicinal product and is one of the measures of non-tariff regulation in the foreign trade system. The registration is a complex activity associated with various components, for example preclinical, clinical researches, pharmacovigilance, quality control, production, pharmaceutical inspection and information interaction. The system analysis of the activity performed by the Supreme Eurasian Economic Council, the Council and College of the Eurasian Economic Commission for the period of 2014-2017 made it possible to determine
Ключевые слова:
Common market of medicinal products; Registration of medicinal products; The Eurasian Economic Union
article; clinical research; college; drug surveillance program; market; pharmacoeconomics; preclinical study; quality control; registration; system analysis
Язык текста: Английский
ISSN: 0975-1459
Zakharochkina E. R. Elena Revovna 1966-
Rayisyan M. G.
Bekhorashvili N. Nana 1981-
Garankina R. Yu. Rimma Yuryevna 1964-
Ryajemov V. V.
Simonyan M.
Захарочкина Е. Р. Елена Ревовна 1966-
Райисян М. Г.
Бехорашвили Н. Нана 1981-
Гаранкина Р. Ю. Римма Юрьевна 1964-
Ряйемов В. В.
Симонян М.
Uniform rules for registering medicinal products in the Eurasian Economic Union
Текст визуальный непосредственный
Journal of Pharmaceutical Sciences and Research
Vol.10, Issue5 P. 1045-1047
2018
Статья
Common market of medicinal products Registration of medicinal products The Eurasian Economic Union
article clinical research college drug surveillance program market pharmacoeconomics preclinical study quality control registration system analysis
The pharmaceutical component of the regional and integration cooperation within the Eurasian Economic Union is characterized by the formation of the common market of medicinal products. The unified principles and rules of the medicinal products’ circulation are determined by a considerable number of new legislative and regulatory documents that regulate various types of activities on the pharmaceutical market. Registration is an important stage in the lifecycle of a medicinal product and is one of the measures of non-tariff regulation in the foreign trade system. The registration is a complex activity associated with various components, for example preclinical, clinical researches, pharmacovigilance, quality control, production, pharmaceutical inspection and information interaction. The system analysis of the activity performed by the Supreme Eurasian Economic Council, the Council and College of the Eurasian Economic Commission for the period of 2014-2017 made it possible to determine