vedomostiregmedРегуляторные исследования и экспертиза лекарственных средствRegulatory Research and Medicine Evaluation3034-30623034-3453Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)vedomostiregmed-79Research ArticleСтатьиРоль фармакопеи в условиях глобализации экономики стран и пути ее развитияThe role of pharmacopoeia in the context of globalization of world economies and its development prospectsТитоваА. В.TitovaA. V.noemail@neicon.ruСадчиковаН. П.SadchikovaN. P.noemail@neicon.ruРоссийский национальный исследовательский медицинский университет им. Н. И. ПироговаРоссияN. I. Pirogov Russian National Research Medical UniversityRussian FederationПервый Московский государственный медицинский университет им. И. М. СеченоваРоссияI. M. Sechenov First Moscow State Medical UniversityRussian Federation201613022018024249Copyright © Титова А.В., Садчикова Н.П., 20182018Титова А.В., Садчикова Н.П.Titova A.V., Sadchikova N.P.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.vedomostincesmp.ru/jour/article/view/79

В статье рассмотрены процессы развития и роль национальных и региональных фармакопей в условиях глобализации мировой экономики. Выделены три основных направления развития процессов глобализации: расширение территории влияния национальных фармакопей, создание наднациональных (региональных и надрегиональных) фармакопей и гармонизация фармакопей. Сделан вывод о взаимосвязи национальных и региональных фармакопей, которые должны способствовать развитию друг друга. Гармонизация фармакопей должна идти по пути унификации методов и методик анализа, но в то же время учитывать национальные факторы и приоритеты стран-участниц гармонизации.

The article reviews the process of development and the role of national and regional pharmacopoeias in the context of globalization of world economies. Three major paths of globalization identified are: enlargement of national pharmacopoeias’ area of influence, formation of supranational (regional and supraregional) pharmacopoeias and harmonization of pharmacopoeias. The article draws a conclusion on interrelation of national and regional pharmacopoeias that aim to contribute to each other’s development. Harmonization of pharmacopoeias should follow the path of alignment of test methods and analytical procedures and at the same time accommodate national factors and priorities of countries that are involved in harmonization.

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The authors declare that there are no conflicts of interest present.