The Board of the Eurasian Economic Commission approved amendments to the EAEU Pharmacopoeia, which provides a unified approach to assessing the quality of medicines for the five states of the Eurasian Economic Union. The amendments include 144 new general chapters of Pharmacopoeia, and also provide for making changes to a number of existing general chapters of Pharmacopoeia.
General pharmacopoeial monographs and chapters contain descriptions of methods and procedures for pharmaceutical and technological testing of the quality of medicinal products, requirements for various types of dosage forms (tablets, capsules, ointments, aerosols and others), requirements for packaging of medicinal products that are necessary to confirm the proper quality and effectiveness of medicinal products.
Pharmacopoeial chapters (monographs) are prepared by the EAEU Pharmacopoeial Committee taking into account the national pharmacopoeias of the Union states. Apart from members of the EAEU Pharmacopoeia Committee, experts in the field of analytical chemistry, molecular biology and microbiology, and pharmaceutical analysis took part in the work.
The changes will come into effect on April 1, 2023. Manufacturers of pharmaceuticals previously registered in the Union’s common market shall bring their regulatory documents on the medicinal product quality in line with the EAEU Pharmacopoeia until January 1, 2026.
Amendments to the EAEU Pharmacopoeia are the result of regular work on the preparation of harmonized general and particular pharmacopoeial chapters (monographs) and their subsequent addition to the previously approved document. So far, the EAEU Pharmacopoeia Committee has already prepared more than 70 pharmacopoeial monographs for the third part of the EAEU Pharmacopoeia. A preliminary discussion of draft pharmacopoeial chapters (monographs) is arranged on the EEC website at: https://eec.eaeunion.org/comission/department/deptexreg/formirovanie-obshchikh-rynkov/pharmacopoeia/pharmacopoeia_PO.php
The EAEU Pharmacopoeia is the second regional pharmacopeia in the world out of more than 90 national pharmacopoeias included in the list of world pharmacopoeias maintained by the World Health Organization.