Ukraine studies organisational models of EU pharmaceutical regulators

On 9 March 2026, a meeting with experts from Poland and Lithuania took place within the framework of the EU–Ukraine Twinning Project “Support to the Establishment of the State Control Authority for Medicines and Medical Devices”. The event was dedicated to the presentation of the organisational structure, financing system, and operational procedures of regulatory authorities for medicines and medical devices in European Union Member States.

The discussion formed part of the practical preparation for establishing a new State Control Authority in Ukraine responsible for regulating the circulation of medicines and medical devices. One of the key objectives of the pharmaceutical reform is to build a modern institution based on the model of European regulatory authorities, where core regulatory functions operate within a single integrated system.

During the first session of the meeting, Polish experts presented the experience of the national regulatory authority of Poland and its institutional evolution following the country’s accession to the European Union. Participants learned about the key transformations that took place in the system of medicines regulation after Poland joined the EU, including the harmonisation of national legislation, the introduction of European procedures for the evaluation of medicines, and integration into the EU regulatory network.

The Polish experience is particularly important for Ukraine, as the country went through a similar process of adapting its national regulatory system to EU standards. Studying the practical steps that enabled Poland to integrate into the European regulatory system helps Ukrainian specialists better understand how an effective and independent regulator should function.

The subsequent presentations focused on a detailed overview of the organisational structure of the institution and the functional areas of its activities. Experts presented the governance model of the regulatory authority and the key functions of departments responsible for international cooperation, inspections, marketing authorisation of medicines, variations and renewals of authorisations, evaluation of registration dossiers, clinical trials, pharmacovigilance, maintenance of regulatory registers, parallel import of medicines, and regulation of medical devices.

Particular attention was also given to the organisation of the President’s Office of the institution, as well as to the functioning of the quality management system and internal operational procedures. These elements ensure transparency of regulatory processes, a clear distribution of responsibilities between departments, and effective decision-making in the regulation of medicines.

“For us, it is important to clearly understand how regulatory authorities operate in European Union Member States. This allows us to see in practice how the functions of medicines evaluation, inspections, pharmacovigilance, and regulation of medical devices are integrated within a single institution. Such analysis helps us shape the organisational model of the Ukrainian regulator in line with European approaches to governance, accountability, and the distribution of functions,” said Maryna Slobodnichenko, Deputy Minister of Health of Ukraine for European Integration.