A Twinning project to create a new regulatory body in the pharmaceutical sector has been launched in Ukraine
The implementation of a Twinning project aimed at creating a modern, transparent and independent regulatory body has officially begun in Ukraine. This was reported by the press service of the Ministry of Health.
The project involves an institutional partnership, within the framework of which civil servants from EU countries directly cooperate with Ukrainian colleagues, transferring effective management models, technical solutions and regulatory practices. The goal is to implement structural changes at the institutional level.
Ukraine’s partners are Lithuania, Poland and Germany, with the support of the European Commission, which has allocated 1.5 million euros for the implementation of the initiative. Experts from pharmaceutical agencies in Croatia and France will also join the work. These countries have significant experience in reforming the regulatory system and harmonizing legislation with EU standards, which will become the basis for creating a modern supervisory authority in Ukraine.
From October 21 to 31, a consortium mission was in Ukraine – project leaders from Lithuania and Poland and experts who coordinated the start of work and the official launch of the Twinning process. The delegation held a number of meetings with representatives of the Ministry of Health of Ukraine, the State Expert Center and the State Service for Medicines and Drug Control.
On October 29, a working meeting of the Minister of Health of Ukraine, Viktor Lyashko, with project experts and representatives of regulatory agencies of Poland and Lithuania took place. Deputy Minister for European Integration Maryna Slobodnichenko and Deputy Minister Edem Adamanov also participated.
The European partners at the meeting were Grzegorz Ciessak, Head of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products in Poland, Douville Marcinke, Director of the State Medicines Control Service of Lithuania, and Daumantas Gutauskas, Head of the National Blood Center of Lithuania.
During the meeting, the parties discussed strategic goals for the next 21 months – the project implementation period. The main tasks include harmonizing Ukrainian legislation with the EU acquis, developing the structure of the future body, defining internal policies, recommendations on financing, training experts and strengthening institutional capacity.
The main goal of Twinning is to increase Ukraine’s capacity to create a single independent regulator in the field of control of medicines and medical devices, which will meet European standards.
The project envisages a gradual approximation of the Ukrainian regulatory system to EU standards by adapting national legislation to the EU acquis. The institutional structure of the new body, operational procedures, funding models and communication strategy will be developed. It is also planned to train specialized specialists and modernize regulatory processes in the areas of quality control, clinical trials, pharmacovigilance, and compliance with international requirements (GMP, GDP, GPP, GCP).
These changes should guarantee Ukrainian patients access to safe and high-quality medicines, stimulate the development of the pharmaceutical industry, and create conditions for Ukrainian companies to enter European markets.
The new body is planned to be launched on January 1, 2027. Its creation will allow harmonizing the state system of control over the circulation of medicines and medical devices in accordance with European Union standards.
