The clock is ticking on the fresh and stylish landing page of the Ukrainian Medicines Agency (UMA) — a new central body set to replace Derzhliksluzhba, with expanded responsibilities and nearly three times the size of the legacy regulator.
What Changes on the Surface
The headline numbers are stark. The current Derzhlikssluzhba operates with 459 authorised staff positions. The UFA’s approved headcount will be 1,291 — nearly three times larger — making this one of the most significant institutional expansions in Ukrainian healthcare governance in years.
The transition is planned in two stages: the UFA will be formally established as a legal entity during 2026, with the full-scale merger and operational launch set for 1 January 2027. Ukraine’s international regulatory memberships — including PIC/S, the European Pharmacopoeia, and EDQM — will be preserved through legal succession, guaranteeing continuity of international recognition.
Why It Is Happening: A Dramatically Broader Mandate
The tripling of staff reflects a genuinely expanded scope of responsibilities. The UFA consolidates what are currently fragmented functions across multiple agencies. Its new mandate covers:
- Medicines registration & market authorisation — full lifecycle oversight from expert review of registration dossiers through to post-market decisions and variations
- Clinical trials — reviewing trial materials, issuing approvals or refusals for trial authorisations, and conducting site inspections
- Pharmacovigilance — coordinating safety monitoring and conducting inspections of pharmacovigilance systems held by applicants and marketing authorisation holders
- Medical devices & diagnostics — technical regulation and market surveillance covering medical devices, in vitro diagnostics, active implantable devices, bioimplants, and cosmetics
- Narcotics & controlled substances — overseeing the lawful circulation of narcotics, psychotropic substances, their analogues and precursors, and combating illicit trade
- Blood safety — regulation of blood donation, blood components, and the functioning of the national blood supply system
Funding will shift partly away from the state budget. Annual contributions will be levied on marketing authorisation holders, manufacturers, importers, distributors, and pharmacy owners. The agency’s performance will be subject to annual independent external review by a three-person oversight commission.
Oleks’s (Author) Take
Navigating the current pharmaceutical landscape in Ukraine is a nightmare. Regulatory, expert, advisory, administrative, and monitoring functions are scattered across several agencies with no clear boundaries between them. Having a unified, one-stop service provider is a genuinely welcome development — good for businesses and consumers alike.
That said, I’m a bit surprised the reform hasn’t gone one step further and transposed the agency into a national competent authority with direct reporting lines to the European Medicines Agency (EMA). Such a move would help harmonise Ukraine’s currently immature pharmaceutical market — flooded with non-evidence-based medications and questionable supplements that a corrupt regulator permitted to circulate and be actively marketed to consumers — with the far more transparent and mature European market.
Sources: Apteka.UA; Ministry of Health of Ukraine draft resolution, January 2026.