Unified Pharmacopoeia of the EAEU approved
The Board of the Eurasian Economic Commission approved the EAEU Pharmacopoeia, which will become a single one for assessing the quality of medicines in five union countries. The EAEU Pharmacopoeia has become the second regional pharmacopoeia in the world. The document will take effect from March 1, 2021, according to the EEC website.
Manufacturers of medicinal products previously registered in the common EAEU market must bring their regulatory documents in line with the new pharmacopoeia by January 1, 2026.
The first part of the first volume of the approved pharmacopoeia includes 157 harmonized general pharmacopoeial monographs (monographs) containing general information on the application of pharmacopoeial analysis and its methods, methods of biological and microbiological tests, reagents, instruments and apparatus for analyzing the quality of both those already on the market and new , drugs still under development. The plans include filling the document with new general and particular articles with the preparation of the publication of its next volumes.
“Pharmacopoeia monographs are harmonized with the leading pharmacopoeias of the world, and this will ensure continuity in conducting research on the quality of medicinal products and facilitate the entry of the Union’s pharmaceutical products to foreign markets,” said Viktor Nazarenko, Member of the Board (Minister) for Technical Regulation of the EEC.
The creation of a unified pharmacopoeia was the result of three years of work. Pharmacopoeial monographs were prepared by the EAEU Pharmacopoeia Committee taking into account the national pharmacopoeias of the Union states, the regional pharmacopoeia of the European Union. Already, the EAEU Pharmacopoeial Committee has prepared more than 100 pharmacopoeial monographs for the second part of the pharmacopoeia.