From the State Service of Ukraine on Medicines and Drugs Control to the Ukrainian Pharmaceutical Agency: how will state control over medical products change

Effective on 1 January 2027, Ukraine plans to establish a unified regulatory body, the Ukrainian Pharmaceutical Agency (UFA), responsible for overseeing the quality and safety of medical products. This new entity will assume certain responsibilities currently held by the State Service of Ukraine on Medicines and Drugs Control, the liquidation of which is currently envisaged in the context of the reform.

Significant transformations within the pharmaceutical sector can only be realized when there is a shared understanding among all stakeholders involved. The SMDC of Ukraine is fostering collaboration with the pharmaceutical community through open and constructive dialogue, consultations, and partnerships.

However, during these discussions, a range of perspectives, some of which may be inaccurate, have been presented regarding the operations of the SMDC of Ukraine, requiring further clarification and explanation of certain assertions.

This situation highlights the necessity for a more comprehensive understanding of our institution’s operations, rather than being a result of intentional misinformation. Consequently, the SMDC of Ukraine will provide clear explanations regarding its current activities, the underlying mechanisms of state regulation concerning the quality and safety of medical products, the skilled professionals involved in executing this intricate and crucial work, and the anticipated roles of Ukrainian Pharmaceutical Agency. Initial publications as part of this informational initiative have already been released. Notably, the weekly publication “Apteka” has recently disseminated materials addressing the standards of good distribution practice, state oversight in the domain of blood and blood component donation, and the preparation of the Ukrainian system for the adoption of the European SoHO framework.

In the future, we intend to disseminate information regarding the methodologies employed in the quality control of pharmaceuticals, the inspection protocols for pharmaceutical manufacturing facilities, as well as the oversight of medical devices and the regulatory framework governing cosmetic products. The SMDC of Ukraine places significant emphasis on the professionals who uphold the system’s functionality, particularly those with specialized expertise and unique professional experience.

This kind of human capital has been built up over the years, largely thanks to the preservation of institutional memory, where experienced professionals pass on their knowledge to the younger generation of professionals directly during the resolution of real work tasks. The preparation of a specialist takes years, and maintaining a proper level of competence requires constant training.  

We will also introduce you to the people behind it all, our experts and their unique experience. It has taken years to build such a strong team, thanks to the preservation of tradition and succession, where experts train the young directly in the work process. And since it takes years to prepare an expert of this level, our training never stops.

So reform is not just about creating a new structure on paper. It is about people, their knowledge, experience and years of work on the system of quality and safety control of medical products.