Implementing institutions
State Medicines Control Authority, National Blood Centre, Central Project Management Agency, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of Poland, Federal Ministry of Health of Germany, Federal Ministry for Economic Affairs and Energy of Germany.
Objective of the project
The overall objective of this Twinning project is to support and strengthen Ukraine’s health sector and protect patients’ interests by ensuring access to quality, safe, effective, and innovative medicines, medical devices, and cosmetic products. The specific objective of this Twinning project is to build the State Control Authority (SCA) as a regulatory body capable of functioning within the network of EU competent authorities.
Components
- Draft regulatory framework on medicines, medical devices and cosmetic products is aligned with the EU acquis.
- SCA structure and operational parameters defined.
- SCA’s capacity strengthened with advanced methodologies in line with the best EU regulatory practices.
Key results achieved to date
- An action plan for revision and drafting of legal acts was developed and approved.
- Comprehensive recommendations on the SCA’s organizational structure and financing model were delivered, and an ethics and anti-corruption package was prepared to align internal oversight mechanisms with EU standards.
- Training sessions and study visits were organized to strengthen capacity in the supervision of the medical devices and cosmetics markets, hospital pharmacy activities, and the safety and quality of substances of human origin.
