Ukraine is confidently moving towards the creation of a single, modern, independent and effective regulatory body in the field of circulation of medicinal products and medical devices, whose activities will comply with the best European practices and the requirements of EU legislation.
In Berlin, the 4th meeting of the Steering Committee of the Twinning project on supporting the creation of the SCA was held, where Ukraine, together with representatives of the consortium of EU partner states – Lithuania, Poland and Germany – summarised the results of the project implementation for the reporting period and outlined priorities for the next stage.
The meeting was attended by the Deputy Director of the Center for Legal Affairs and Component 1 Leader Hanna Husieva.
The meeting participants noted that the project has successfully reached half of the planned implementation period. To date, a number of important activities have been completed, in particular:
- proposals were prepared on harmonising Ukrainian pharmaceutical legislation with the legislation of the European Union
- recommendations were developed on the internal policies of the future competent authority
- a set of training events was held in the areas of licensing, market surveillance of medical devices and cosmetic products, manufacture of medicinal products in pharmacy settings, and ensuring safety standards for substances of human origin (SoHO).
Particular attention during the meeting was paid to the results of work on adapting Ukrainian legislation to the acquis of the European Union. Among the key developments is the preparation of proposals on implementing European approaches to data protection, regulation of generic medicinal products, parallel import, and labelling of medicinal products in Ukrainian.
The participants also reviewed the progress of implementation of current missions and the financial state of the project, and outlined an action plan for the next period.
In the second half of 2026 the year, work will continue on improving legislation in the main areas of activity of the new state body:
- pharmacovigilance and registration of medicinal products
- market surveillance of medical devices and cosmetic products
- introduction of European standards in the area of safety of substances of human origin
- licensing, inspection and quality control.
Following the meeting, the Steering Committee confirmed the shared interest in the further successful implementation of the project and the achievement of its main goal. For her part, Hanna Husieva noted the support of the partners and the valuable experience in implementing European changes.
Moving forward – the next 5-th meeting of the project Steering Committee is scheduled for October 2026.
