Preparations Continue for the Establishment of the Ukrainian Pharmaceutical Agency - a New State Authority for Medicines Regulation
The Ministry of Health of Ukraine has submitted for public consultation a draft Resolution of the Cabinet of Ministers of Ukraine “On the Establishment of the Ukrainian Pharmaceutical Agency”.
The document has been developed pursuant to the Law of Ukraine “On Medicinal Products”, which provides for the creation of a single state authority responsible for regulation and control in the field of medicines circulation. This step is part of the systemic transformation of pharmaceutical regulation in line with European approaches.
The draft resolution предусматриває the establishment of the Ukrainian Pharmaceutical Agency as a central executive authority with a special status.
The new Agency will be responsible for implementing state policy in the areas of development, state registration, market authorisation, quality control, safety and efficacy of medicinal products. It will also conduct scientific assessment of registration dossiers, evaluate clinical trial documentation, make decisions on authorisation of clinical trials, ensure pharmacovigilance, and carry out relevant inspections.
The Agency’s mandate will also cover the implementation of state policy in the fields of medical devices, cosmetic products, blood donation and the functioning of the blood system, as well as the circulation of narcotic and psychotropic substances.
The Head of the Agency will be appointed following an open competition.
The Agency’s activities will be financed from the state budget as well as from fees paid by market participants, including for specific services (such as marketing authorisation of medicinal products), pharmacovigilance activities, and annual contributions to ensure quality and safety control of medicines.
The Agency’s work will be subject to annual independent external evaluation conducted by an external oversight commission.
As part of the reform, the State Service of Ukraine on Medicines and Drugs Control will be reorganised through its integration into the Ukrainian Pharmaceutical Agency.
The new authority is expected to begin operations on 1 January 2027. Throughout 2027, a transition period will be implemented, during which the State Expert Centre of the Ministry of Health will complete the assessment of applications submitted by 31 December 2026, ensuring continuity of state registration procedures for medicinal products.
Preparations for the establishment of the Ukrainian Pharmaceutical Agency are being carried out with the support of a Twinning project involving European partners. In particular, on 28 January 2025, a Steering Committee meeting of the project was held in Vilnius, during which the parties reviewed progress achieved in the first quarter and agreed on further steps to develop the new regulatory authority.
“The Twinning project involving our European partners significantly strengthens Ukraine in the process of establishing a new state regulatory authority. This includes cooperation with Lithuania, Poland and Germany, as well as experts from the pharmaceutical agencies of Croatia and France, who share their practical experience of regulatory reforms and harmonisation of legislation with EU law. This is an institutional partnership under which civil servants from EU Member States work directly with Ukrainian colleagues, sharing operational models, management practices and technical solutions. Thanks to this cooperation, Ukraine is building a solid foundation for the creation of a modern regulatory authority”
It should be recalled that the implementation of the Twinning project aimed at establishing a new regulatory authority in the fields of medicinal products and medical devices has been ongoing since October 2025, with the support of the European Commission and in partnership with experts from Lithuania, Poland, Germany, Croatia and France.
Background. Twinning is an EU institutional capacity-building instrument used to support candidate countries. Its objective is to assist in harmonising national legislation and establishing effective public institutions in line with EU standards. This is the first Twinning project being implemented in Ukraine’s health sector.