Visit to the USA

Roman Isaienko, Head of the State Service of Ukraine on Medicines and Drugs Control (SMDC/Ukraine), as a delegation member of the Ministry of Health of Ukraine, headed by Maryna Slobodnichenko, Deputy Minister of Health, visited U.S. Pharmacopeia – Europe, Middle East & Africa and the U.S. Food and Drug Administration (FDA) during a business trip to the United States.

During the visit, Ukrainian officials met with the leadership and staff of the United States Pharmacopeia (USP) and visited its laboratories. The cooperation between the SMDC and the USP was formalized in 2011 by signing a bilateral Memorandum of Understanding. The SMDC applies the USP standards and methods of laboratory practice in Ukrainian laboratories and conducts independent quality assessment of medicines imported and manufactured in Ukraine.

Pharmacopoeias set quality standards for the medicines and vaccines manufacturing process. At the same time, regulators ensure that manufacturers comply with these quality standards before obtaining marketing authorization and monitor compliance throughout the product’s expiration date.

The Ministry of Health of Ukraine delegation also met with officials of the U.S. Food and Drug Administration (FDA), which is a federal agency of the U.S. Department of Health and Human Services that ensures the safety and effectiveness of all drugs, biological products (including blood, vaccines, cell and gene therapy products), medical devices, cosmetic products, and regulates food.

Such meetings are aimed at improving partnerships and strengthening international cooperation to ensure the quality and safety of pharmaceutical products, which will contribute to the sustainability of the national healthcare system.

This visit was supported by the Management Sciences for Health project, which implements the program «Safe, Affordable, and Effective Medicines for Ukrainians» (USAID Ukraine/SAFEMed).