The Cabinet of Ministers has approved a decision to establish the Ukrainian Pharmaceutical Agency

The Cabinet of Ministers of Ukraine has officially adopted a resolution establishing the Ukrainian Pharmaceutical Agency (Ukrpharma). The new agency will become the sole state regulatory body in the pharmaceutical sector and will begin full-scale operations on January 1, 2027. 

The creation of this agency is a key step in the reform of state regulation of medical products and an important part of Ukraine’s European integration commitments, fully aligning with the practices of European Union member states. 

The newly established agency will be granted broad powers and will implement a unified state policy in the areas of development, market authorization, and quality control of medicinal products. The Ukrainian Agency for Medicines will also oversee medical devices (including those for in vitro diagnostics and active bioimplants), cosmetic products, the circulation and counteraction of the illicit trafficking of narcotic and psychotropic substances, as well as oversight of the blood and blood component donation system. It is expected that the activities of the single regulator will significantly improve patient access to innovative medicines, ensure transparent oversight of medical products throughout their entire lifecycle, and strengthen the country’s integration into the single European regulatory space.

The next step in launching the agency’s operations will be the selection of its head through a transparent competitive process. To this end, a special six-member selection committee will be formed, comprising three international experts and three representatives from the Ministry of Health of Ukraine. The preparations for launching the regulator are being carried out with the support of the European Twinning project, which is funded by the European Commission and implemented by a consortium of relevant agencies from Lithuania, Poland, and Germany. In addition, the Ukrainian side is actively cooperating with the European Medicines Agency (EMA) and drawing on the expertise of specialists from Sweden, France, Denmark, Croatia, Estonia, the SAFEMed project, and the Advisory Board.

This was reported by the Ministry of Health.

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