A Twinning Project to Establish a New Regulatory Authority for Medicines and Medical Devices Has Been Launched in Ukraine
Ukraine has officially begun implementing a Twinning project aimed at establishing a modern, transparent, and independent regulatory authority in the pharmaceutical sector.
The initiative represents an institutional partnership in which civil servants from EU member states work directly with Ukrainian counterparts to share operational models, management practices, and technical solutions. This cooperation involves the joint implementation of institutional reforms to bring Ukraine’s system closer to EU standards.
The project partners include a consortium of Lithuania, Poland, and Germany, supported by the European Commission, which has allocated €1.5 million for the initiative. Experts from the pharmaceutical agencies of Croatia and France will also contribute their expertise. All participating countries have extensive experience in regulatory reforms and EU legislative harmonization, which will serve as a foundation for building a modern Ukrainian regulatory authority.
From October 21 to 31, representatives of the consortium — project leaders from Lithuania and Poland along with sectoral experts — visited Ukraine to organize project activities and formally launch the Twinning process. The delegation held a series of meetings with officials from the Ministry of Health of Ukraine, the State Expert Center, and the State Service of Ukraine on Medicines and Drugs Control.
On October 29, Minister of Health Viktor Liashko met with the project experts and the leadership of the Polish and Lithuanian regulatory agencies. The meeting was also attended by Deputy Minister for European Integration Maryna Slobodnichenko and Deputy Minister Edem Adamanov. The European delegation included Grzegorz Cessak, Head of the Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Dovilė Marcinke, Director of the Lithuanian State Medicines Control Agency (SMCA); and Daumantas Gutauskas, Head of the Lithuanian National Blood Center.
During the meeting, the parties discussed the strategic work plan for the project’s 21-month duration and its key challenges. The main objectives include harmonizing Ukrainian legislation with the EU acquis, developing the organizational structure, internal policies, and financing model of the new authority, training Ukrainian experts, and strengthening institutional capacity.
The goal of the Twinning project is to enhance Ukraine’s capacity to establish a single, independent regulatory authority for the control of medicines and medical devices, operating in line with European standards.
The project also envisions the gradual alignment of Ukraine’s regulatory system with the EU acquis — the body of EU law and principles — through the development of an institutional framework, operational procedures, financing mechanisms, and a communication strategy. The initiative will also include training programs for specialized professionals.
Particular attention will be devoted to modernizing regulatory procedures, including quality control, clinical trials, pharmacovigilance, and compliance with international standards (GMP, GDP, GPP, GCP). These changes will ensure access to safe and high-quality medicines for Ukrainian patients, stimulate industry development, and open new opportunities for integration into European markets.
The new regulatory authority is expected to begin operations on January 1, 2027, introducing harmonized approaches to pharmaceutical and medical device regulation in accordance with EU requirements.
The official opening ceremony of the Twinning project took place on October 30, with participation from representatives of the Verkhovna Rada, the Government of Ukraine, the EU Delegation to Ukraine, patient organizations, business associations, EU experts, and diplomats. Among the distinguished guests were Inga Stanytė-Toločkienė, Ambassador of Lithuania to Ukraine; Maximilian Rasch, Deputy Head of Mission of the German Embassy; and Maciej Chrzanowski, Head of the Economic Section at the Embassy of Poland. The event marked the official launch of the project.
During the visit, Lithuanian and Polish experts also visited Ukrainian pharmaceutical companies and the State Enterprise “Central Laboratory for Quality Analysis of Medicines and Medical Products.”
A joint working team has been formed to implement the initiative, comprising 43 Ukrainian experts and over 90 EU experts who will participate throughout the project’s implementation. Work will be conducted both online and through regional hubs in Poland and Lithuania. A Supervisory Committee, including representatives of Ukrainian and EU public institutions, will convene quarterly to oversee progress.
Project activities will be carried out across 13 technical areas, covering the core functions of the future regulatory authority.
The Ministry of Health of Ukraine expresses its deep gratitude to the European Union and partner institutions for their systematic support in advancing structural reforms and bringing Ukraine’s healthcare regulation closer to EU standards.
Background:
The project is funded by the European Union with a total budget of €1.5 million and an 18-month implementation period (21 months including preparatory and reporting stages). The Ministry of Health of Ukraine serves as the main beneficiary, while key partners include the Lithuanian State Medicines Control Agency, the Polish regulatory agency, and the Federal Ministry of Health of Germany.