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EAEU continues harmonizing requirements for medicine quality control
The Board of the Eurasian Economic Commission approved amendments to the Pharmacopoeia of the Eurasian Economic Union, which provides a unified approach to medicines quality assessment for the EAEU States.
The amendments include 46 new general pharmacopoeial monographs containing methods for pharmaceutical and technological testing of medicinal products, analysis of biological medicinal products, general texts on microbiology, requirements as to biological medicinal products and radiopharmaceutical medicinal products necessary to confirm their proper quality and efficiency. The amendments shall come into effect on January 1, 2025.
Pharmacopoeial chapters (monographs) are prepared by the EAEU Pharmacopoeial Committee taking into account the national pharmacopoeias of the Union states. Amendments to the EAEU Pharmacopoeia resulted from the regular work to prepare harmonized general and specific pharmacopoeial monographs in the Member States.
In addition, Decision No. 100 of the Commission Board dated August 11, 2020 was amended to extend the deadline for bringing marketing authorization applications of veterinary medicinal products into compliance with the Union Pharmacopoeia.
So far, the EAEU Pharmacopoeia Committee has already prepared more than 50 pharmacopoeial monographs for the fourth part, volume one of the EAEU Pharmacopoeia. Draft pharmacopoeial monographs are being preliminarily discussed on the EEC website
