The project addresses key gaps in Ukraine’s regulatory system, where regulatory, supervisory, and control functions are currently divided among several bodies, resulting in overlaps, inefficiencies, and challenges for compliance with EU requirements. While Ukraine has made significant progress with legal reforms, including the adoption of the new Law on Medicines, there is a pressing need to operationalise the regulatory framework through the creation of a strong, centralised, and professionally managed authority.

This Twinning project is designed to deliver impact across three mutually reinforcing components:
1. Alignment of the Ukrainian regulatory framework with the EU acquis
2. Definition and strengthening of the SCA’s (State Control Authority) structure and operations
3. Capacity building of SCA staff

Overall, the project is designed to ensure that Ukraine’s new SCA can effectively perform its role in ensuring the safety, efficacy, and quality of medicinal products, medical devices, cosmetics, and related areas, fully aligned with EU standards and able to integrate into the European regulatory network.

The overall objective of this Twinning project is to support 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 SCA as a regulatory body capable of functioning within the network of the EU competent authorities. This is to be achieved by establishing and strengthening the administrative capacity of the State Agency for Medical Devices as an independent body with a special status that implements the state policy on the development, registration, quality control, safety and efficacy of medicinal products, medical devices and medical devices for in vitro diagnostics; cosmetics; trafficking and countering illicit trafficking in narcotic drugs, psychotropic substances and precursors; SoHO, including blood and blood component donation; and the functioning of the blood system, the organisational structure, working methods and financing of which will comply with EU best practices.

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.