Ukraine Establishes New Pharmaceutical Agency, Set to Transform Drug Regulation from 2027

A New Pharmaceutical Regulator for Ukraine

According to ХВИЛЯ: The Ministry of Health of Ukraine has presented a draft resolution to create the Ukrainian Pharmaceutical Agency (UFA). This new body will consolidate the functions of drug control, registration, and supervision under one roof, becoming the central executive authority with a special status. As part of this reform, the State Service of Ukraine on Medicines and Drugs Control will be liquidated and merged into the new agency. The UFA is scheduled to begin its operations at the start of 2027.

This initiative marks a significant step in aligning Ukraine's healthcare system with European Union standards. The establishment of the UFA is being supported by the first-ever Twinning project in Ukrainian medicine, involving collaboration with experts from Lithuania, Poland, Germany, France, and Croatia. These international partners will assist their Ukrainian counterparts in adapting to European regulatory norms. Preparations for the launch of the new regulator will continue over the next 12 months, while the State Expert Center of the Ministry of Health will finalize the review of all materials submitted by December 31, 2026.

Core Functions and Funding Model

The primary responsibilities of the UFA will include:

• Registration and authorization of medicinal products;
• Quality control;
• Expanded oversight covering medical devices, cosmetics, the blood system, and the circulation of narcotic substances.

The head of the UFA will be selected through an open competition. The agency's funding will come not only from the state budget but also from market participants' fees for registration and control services. An independent external commission will conduct an annual evaluation of the agency's performance.

Marina Slobodnichenko, a representative of the Ministry of Health, stated: 'We are strengthened by the experience of our partners, who are sharing practical skills for harmonizing legislation with EU law. This provides a solid foundation for a modern regulator.'

The creation of the Ukrainian Pharmaceutical Agency is therefore expected to bring substantial changes to the regulation of the pharmaceutical sector in Ukraine.

This move represents a crucial step in modernizing Ukraine's pharmaceutical regulatory framework. By adopting European standards and leveraging international expertise, the reform aims to enhance the quality and safety of medicines for the population. The introduction of new functions and a market-based funding model could also stimulate the development of the domestic pharmaceutical industry, which is a key element of Ukraine's broader European integration efforts.