How EU is helping Ukraine create a new medicines regulatory agency and what this will mean
Work on pharmaceutical reform has entered the public phase in Ukraine.
The Ministry of Health of Ukraine has submitted for public discussion a draft resolution of the Cabinet of Ministers of Ukraine On the Establishment of the Ukrainian Pharmaceutical Agency.
The launch of the new state regulatory body in the pharmaceutical sector is scheduled for 1 January 2027.
Read more about the creation of the new Ukrainian Pharmaceutical Agency in line with EU standards in the column by Marina Slobodnichenko, Deputy Minister of Health for European Integration: Moving towards EU pharmaceutical space: what changes await Ukraine soon.
The draft resolution on the establishment of the new pharmaceutical agency already incorporates key European principles, Marina Slobodnichenko emphasises.
The first is the financial sustainability of the future regulator.
"The Ukrainian Pharmaceutical Agency will be a self-financing body operating under the model of European regulatory agencies. That means that alongside state budget funds, the agency will also receive revenue from the market, which will constitute the main part of its financing," the author notes.
The second principle is a transparent remuneration system. Competitive salaries within the regulator will serve as a tool to prevent conflicts of interest, retain qualified professionals and build a strong institutional culture.
A separate track focuses on developing professional capacity and integration into the European space.
According to the Deputy Minister of Health, a key instrument for institutional preparation is a Twinning project (expert support mechanism), implemented in a consortium format with the participation of EU member states – Lithuania, Poland and Germany – as well as experts from the pharmaceutical agencies of Croatia and France.
For one and a half years, the Ukrainian team will work together with European colleagues to harmonise the regulatory framework with EU law.
"The methodological level is strengthened by cooperation with Sweden. In 2026-2027, we are working with the Swedish Medical Products Agency to ensure that the new state regulatory body meets EU standards from the very beginning," the author explains.
The strategic level, she adds, is anchored in cooperation with Denmark.
"Together, these three tracks ensure Ukraine’s systemic integration into the common European pharmaceutical space. In the near future, the newly established Ukrainian Pharmaceutical Agency will become part of the network of regulatory authorities cooperating with the European Medicines Agency," the Deputy Minister concludes.