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Elena Sakanyan, the director of the center of a pharmacopeia and the international cooperation of Federal State Budgetary Institution “Scientific Center of Examination of Means of Medical Application” of the Russian Ministry of Health (Federal State Budgetary Institution NTsESMP), have participated in a special meeting of the countries having the status of observers in the Commission of the European Pharmacopoeia (CEP) of the European management on quality of medicines and health care (to European Directorate for the Quality of Medicines & HealthCare, EDQM) the Council of Europe. The meeting took place at the end of March, 2016 in France (in Strasbourg).
As the press service of Federal State Budgetary Institution NTsESMP transfers, official representatives of the countries observers in KEF participated in a special meeting in Strasbourg: Azerbaijan, Armenia, Belarus, Brazil, Canada, China, river of Korea, Malaysia, Russian Federation, Singapore, USA, Tunisia, etc. These are experts from the national Ministries of Health, institutes of health care, the Pharmacopoeia of committees, universities or pharmaceutical companies.
The main objective of a meeting consisted in acquaintance of observers with the main approaches to drawing up and revision of monographs of the European pharmacopeia. Observers have considered the principles of the KEF organization and have discussed current trends in establishment of the quality standards of medicines.
Now 38 permanent members (the majority of the European countries and official delegation of the European Union) and 28 observers whom also the Russian Federation (presented by the staff of Federal State Budgetary Institution NTsESMP and Russians public health surveillance) treats are a part of KEF.
Federal State Budgetary Institution NTsESMP uses information from committee of the European pharmacopeia during the work on the Russian pharmacopeia and pharmacopeias of the countries of EEU
The center of a pharmacopeia and the international cooperation of Federal State Budgetary Institution NTsESMP is one of the main developers of the general the pharmacopeia and the pharmacopeia of articles intended for inclusion in the State pharmacopeia of the Russian Federation the XIII edition and a regional pharmacopeia of the countries of EEU. Participation in work of KEF as observers gives the chance to get acquainted in due time with all materials, including the changes made to the operating EF, and also various managements and recommendations, new monographs of EF. In the subsequent experts of Federal State Budgetary Institution NTsESMP use this information when carrying out procedure of examination for registration of medicines. The center of a pharmacopeia and the international cooperation of Federal State Budgetary Institution NTsESMP considers the data obtained within work in KEF when developing projects of the general the pharmacopeia of articles and the pharmacopeia of articles for the State pharmacopeia of the Russian Federation and a pharmacopeia of the countries of EEU within harmonization of requirements imposed to quality of medicines in the Russian Federation and abroad.