Formation of a common market for medicinal products and the implementation of the Agreement on Common Principles and Rules for Circulation of Medicinal products within the framework of the Eurasian Economic Union are currently regulated by a number of documents approved by the decisions of the Eurasian Economic Commission and setting requirements for ensuring safety, effectiveness and quality of medicinal products. However, the introduction of the common market still has challenges due to the lack of a common document to ensure the quality of medicinal products – a unified pharmacopoeia.
The first meeting of the Pharmacopoeial Committee of the Eurasian Economic Union (EAEU) was held on February 2-3. The task was set to develop and prepare for adoption a unified Pharmacopeia of the EAEU – the main code of requirements for the quality of medicinal products. The Pharmacopoeial Committee included experts in the field of pharmacy, pharmaceutical chemistry, and analytical chemistry of the member countries. At the same time, it implemented an equiproportional representation of each country. Since the Pharmacopoeia of the EAEU to be established (hereinafter - the Pharmacopoeia of the Union) will also include requirements for veterinary preparations, the committee also included experts in the field of veterinary pharmacy.
The implementation of unified modern standards of the Pharmacopoeia of the Union will guarantee the provision of the EAEU market with safe medicines of high quality. In its activities, the Pharmacopoeial Committee targets the best world practices. The Pharmacopoeia of the Union will become the second regional pharmacopoeia in the world after the European Pharmacopoeia.
Regulation of the Eurasian Economic Commission Collegium No. 4 dated January 16, 2017 approved the staff of the EAEU Pharmacopoeial Committee. Ms Elena Ivanovna Sakanyan, Professor, Doctor of Pharmacy, Director of the Centre for Pharmacopoeia and International Cooperation of the Scientific Centre for Examination of Medical Products of the Ministry of Healthcare of the Russian Federation was appointed Chairperson of the Pharmacopoeial Committee. Mr Sergey Igorevich Marchenko, Deputy Director of the Centre for Examinations and Tests in Health Service of the Republic of Belarus, Unitary Enterprise, and Ms Ardak Urinbasarovna Tulegenova, Professor, Doctor of Pharmacy, Member of the National Academy of Sciences of the Republic of Kazakhstan, Head of the Centre for Development and Improvement of the State Pharmacopoeia of the Republic of Kazakhstan and Pharmacopoeia of the EAEU of the Ministry of Healthcare of the Republic of Kazakhstan, were elected her deputies.
The Pharmacopoeial Committee will have to promptly perform large-scale activities to approve 189 common pharmacopoeial articles, which will constitute the first volume of the Pharmacopoeia of the Union.
At the first meeting of the Pharmacopoeial Committee, a schedule of meetings for 2017-2018 was formed, 40 drafts of common pharmacopoeial articles were considered, 13 of which were approved, 27 were sent for revision and will be submitted for consideration at the next meeting in March. There was made a decision to make a list of testing laboratories of the member countries for the work of the Pharmacopoeial Committee, as well as laboratories for the certification of pharmacopeial reference samples.
The Pharmacopoeia of the Union will be based on the standards of the national pharmacopoeias of the EAEU member countries and harmonized with the European Pharmacopoeia, which is recognized as the basic one (basic pharmacopoeia of the first level), as well as with other leading pharmacopoeias of the world (the British Pharmacopoeia, the United States Pharmacopoeia). The use of the European Pharmacopoeia as a basic pharmacopoeia for the establishment of the Pharmacopoeia of the Union is fully justified, since the second level documents for the implementation of the Agreement on Common Principles and Rules for Circulation of Medicinal products within the framework of the Eurasian Economic Union, including all good practices, have been developed using international experience, first of all, based on the documents of the European Union.
The establishment of the Pharmacopoeia of the Union will ensure functioning of the adopted documents necessary for launching the Eurasian Economic Union common market of medicinal products, create favourable conditions for the development of the pharmaceutical industry and the release of medicinal products produced in the territories of the EAEU member countries to the world market.