The State Enterprise «Ukrainian Scientific Pharmacopoeial Center for Quality of Medicines» (hereinafter – the Pharmacopoeial Center) of the State Service of Ukraine on Medicines and Drugs Control received a letter of gratitude from the Council of the United States Pharmacopoeial Convention (USP) and its employees, who noted the contribution of the Pharmacopoeial Center to the development of draft concepts of resolutions for the cycle 2025-2030.
The Pharmacopoeia Center has been a member of the USP since 2010. During 2012-2013, Oleksandr Hryzodub was its representative in the USP, and since 2023 – Natalia Volovyk.
Notably, in July 2024, during a working visit to the United States as a member of the Ministry of Health delegation, Head of the State Service of Ukraine on Medicines and Drugs Control Roman Isaienko and other members of the delegation met with the leadership and employees of the USP and visited its laboratories.
Cooperation between the State Service of Ukraine on Medicines and the USP was officially established in 2011 by signing a bilateral Memorandum of Understanding.
The State Service of Ukraine on Medicines and Drugs Control applies USP standards and methods of laboratory practice in Ukrainian laboratories and conducts independent quality assessment of imported and manufactured medicines in Ukraine.
Pharmacopoeias establish quality standards for the manufacturing of medicines and vaccines. At the same time, regulators guarantee that manufacturers comply with these quality standards before obtaining marketing authorization and monitor the compliance of the requirements during the whole shelf life of the product.
The Pharmacopoeial Analysis Laboratory of the SE «Pharmacopoeial Center» located in Kharkiv is one of the authorized laboratories of the State Service of Ukraine on Medicines and Drugs Control, which continues to perform its work in the sphere of medicines quality control using unique biological control methods and despite all the risks caused by the military aggression of the Russian Federation against Ukraine.
In addition to the analyzes performed by the Pharmacopoeial Analysis Laboratory of the SE «Pharmacopoeial Center» for the Ukrainian pharmaceutical market, it technically supports the development of the State Pharmacopoeia of Ukraine, which is a regulatory document containing general requirements for medicines, monographs and methods for controlling active ingredients, medicines, reagents, etc.
Ukraine was the first country from the post-Soviet states that developed a national pharmacopoeia. The first edition of the State Pharmacopoeia of Ukraine was implemented on October 1, 2001.