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EAEU created conditions for unified quality control of medicines

EAEU created conditions for unified quality control of medicines

8/12/2020
The Board of the Eurasian Economic Commission has approved the EAEU Pharmacopoeia which will lay the groundwork for a unified approach to assessing the quality of medicinal products for five Union countries. The document will enter into force on March 1, 2021. Manufacturers of pharmaceuticals previously registered in the Union’s common market have been granted a 5-year period - until January 1, 2026 - to harmonize their regulatory documents on the medicinal product quality with the Union's Pharmacopoeia.

The first part of Volume I of the Union's Pharmacopoeia includes 157 harmonized general pharmacopoeial monographs containing general information on applying the pharmacopoeial analysis and its methodologies, methods of biological and microbiological tests, reagents, devices and apparatus for analyzing the quality of both medicines already available in the market and new medicines still under development. It is planned to fill the document with new general and specific monographs as its next volumes will be prepared for publication.

"The pharmacopoeial monographs have been harmonized with the leading world pharmacopoeias, and this will enable ensuring the continuity in conducting research on the quality of pharmaceuticals and facilitate introducing the Union's pharmaceutical products to foreign markets," noted Viktor Nazarenko, Member of the Board – EEC Minister in charge of Technical Regulation.

According to the list of world pharmacopoeias maintained by the World Health Organization (WHO), the Union's Pharmacopoeia has become the second regional pharmacopoeia in the world.

Applying the pharmacopoeial monographs will enable national and foreign pharmaceutical manufacturers and the EAEU States’ supervisory authorities to apply unified approaches to assessing the quality of pharmaceuticals. The document has an important educational function, ensuring the harmonization of the EAEU States’ standards in the field of pharmaceutical training.

Creating the Union's Pharmacopoeia has resulted from three years of patient work, sometimes hard work in terms of choosing approaches to harmonizing and coordinating positions of specialists in the field of pharmaceutical analysis. The pharmacopoeial monographs have been elaborated by the EAEU Pharmacopoeia Committee considering the Union States' national pharmacopoeias and the regional Pharmacopoeia of the European Union.

Not only members of the EAEU Pharmacopoeia Committee but also specialists in analytical chemistry, molecular biology and microbiology and pharmaceutical analysis were involved in a major team effort. Professional pharmaceutical organizations and associations, pharmaceutical companies of the EAEU States as well as the State Institute of Drugs and Good Practices of the Russian Federation, which carried out scientific and technical editing of the Pharmacopoeia, have largely contributed to evaluating practical applicability of pharmacopoeial monographs as part of their public discussion.

Today, the EAEU Pharmacopoeia Committee has already prepared more than 100 pharmacopoeial monographs for the second part of the Union's Pharmacopoeia. Draft pharmacopoeial monographs are being preliminarily discussed on the EEC website at:

http://www.eurasiancommission.org/ru/act/texnreg/deptexreg/LS1/Pages/pharmacopoeia_PO.aspx​​