Partnership between Ukraine and the EU in establishing the Ukrainian Pharmaceutical Agency

On 28 April 2026, the seventh meeting of the Strategic Advisory Working Group (Advisory Board) on the establishment of the Ukrainian Pharmaceutical Agency was held.

The meeting brought together representatives of the European Commission (DG SANTE), the European Medicines Agency (EMA), the European Directorate for the Quality of Medicines & HealthCare (EDQM), the Verkhovna Rada of Ukraine, the Business Ombudsman Council, as well as international and independent experts. The session was chaired by Maryna Slobodnichenko, Deputy Minister of Health for European Integration.

The agenda focused on two key areas: progress in the implementation of the Twinning project for the establishment of the Ukrainian Pharmaceutical Agency and the financial model of the future regulator.

Progress in the Twinning Project

The Twinning project will run for 21 months, from November 2025 to June 2027, and is implemented by Ukraine in partnership with Lithuania, Poland, and Germany, with the support of the European Commission.

The project is structured around three core pillars:

• Legislative harmonisation — aligning regulatory frameworks within the Agency’s scope with EU requirements;
• Development of the organisational model — including structure, mandate, financial model, and HR policy;
• Capacity building — covering more than 13 areas, including GMP/GDP inspections, pharmacovigilance, blood system control, cosmetics regulation, and others.

As of April 2026, progress has been achieved across all three pillars. Below are the key results from the past three months.

Human Resources Policy

Strengthening and retaining human capital remains a top priority, as a strong team will form the foundation of the effective functioning of the Ukrainian Pharmaceutical Agency.

Together with Twinning experts, we are shaping the structure of the Agency with a strong focus on building expert capacity which is a cornerstone for the success of the reform and Ukraine’s reputation as a reliable partner. Our efforts are not limited to strengthening the team; we are also introducing a modern performance evaluation system and KPI-based incentives. Particular attention is being given to experts in medicines authorisation, both in-house and external. We are guided by best practices from Poland, where independent experts operate as individuals, undergo a formal selection process, and declare the absence of conflicts of interest as well as adherence to confidentiality requirements, said Maryna Slobodnichenko, Deputy Minister of Health for European Integration.

Blood Collection and Testing, SoHO

Specialists from the State Service of Ukraine on Medicines and Drugs Control participated in a training inspection at the Lithuanian National Blood Centre, including its Kaunas branch and a mobile blood collection unit. The exercise covered procedural registries, unified documentation, and key differences between Ukrainian and Lithuanian legislation governing blood system operators.

The Ukrainian Pharmaceutical Agency is envisaged as the competent authority in the field of SoHO (Substances of Human Origin), responsible for the practical implementation of new regulations and state oversight of their enforcement. In cooperation with Lithuanian experts, preparations are underway for a joint inspection of a Ukrainian blood establishment, alongside the development of partnerships with Lithuanian university clinics on SoHO-related legislation.

Support from the European Blood Alliance has already been confirmed for the joint development of Ukraine’s roadmap for the implementation of SoHO regulations.

Pharmacovigilance

From 23 to 27 March, a mission of Croatian experts took place in Ukraine for specialists of the State Expert Center (SEC). The objective was the full alignment of Ukraine’s pharmacovigilance (PhV) infrastructure with stringent European Union safety standards.

Key topics included improvements to the EudraVigilance system, workshops on the PSUSA single assessment procedure, and Risk Management Plans (RMPs). The “gold standard” organisational model of a pharmacovigilance department was reviewed, using the Croatian agency HALMED as a case study.

An assessment of draft Ukrainian regulatory acts by Croatian experts is planned.

Market Surveillance of Medical Devices

With the participation of German experts, a seminar was held on the functioning of the European database on medical devices, EUDAMED, as well as Germany’s experience in using national systems.

Key conclusions for Ukraine:

— integration of a national database with EUDAMED is not feasible;
— manufacturers are required to independently upload data to EUDAMED;
— the creation of a national database is not mandatory, but may be advisable;
— all processes defined under MDR/IVDR must be conducted through EUDAMED.

Technical regulations for medical devices have been developed in line with MDR/IVDR requirements. A comprehensive analysis of the legislative framework governing medical devices has also been completed.

Extemporaneous Compounding of Medicinal Products

Extemporaneous compounding refers to the individual preparation of medicinal products in a pharmacy or hospital setting, based on a physician’s prescription for a specific patient.

Ukrainian specialists are currently undergoing training at the French National Agency for Medicines and Health Products Safety. The programme provides hands-on experience in extemporaneous compounding within a hospital pharmacy, based at Lille University Hospital.

Financing of the Ukrainian Pharmaceutical Agency

European experts were presented with the proposed system of fees and charges for the future operations of the Ukrainian Pharmaceutical Agency. The approaches received positive feedback from international partners.

The model had previously been shared with representatives of Ukrainian businesses to ensure a transparent dialogue with the market and to incorporate stakeholder perspectives.

“With eight months remaining until the launch of the Ukrainian Pharmaceutical Agency, it is essential to maintain momentum. The Agency is scheduled to begin operations on 1 January 2027. Final decisions on financing are still ahead. Ukraine has adopted the philosophy of EU regulators, where financial methodology is not designed to generate profit, but to cover the cost of regulatory services,” concluded Maryna Slobodnichenko.

Advisory Board Expert Feedback

Key reflections from experts shared during the Advisory Board meeting include:

1. Anka Feldhusen, Business Ombudsperson, emphasised that the establishment of the Ukrainian Pharmaceutical Agency is a critical step towards strengthening trust among international partners and the business community. She highlighted that building a transparent, independent, and institutionally capable regulator is essential for Ukraine’s integration into the European pharmaceutical market and will enhance predictability for all market participants.
2. Krzysztof Landa noted Ukraine’s openness to cooperation and its readiness to integrate European approaches to medicines regulation. According to him, active engagement with international partners will bring Ukraine closer to full integration into the European regulatory framework.
3. Olha Stefanyshyna, Member of Parliament of Ukraine and Chair of the Subcommittee on the Adaptation of Ukrainian Legislation to EU Law, underlined the existence of strong political support for legislative changes in the pharmaceutical sector. She also raised the issue of timelines for submitting the relevant legislative amendments to the Verkhovna Rada of Ukraine.
4. Aude L’Hirondel, representative of the European Commission (DG SANTE), concluded that Ukraine is moving in the right direction in preparing for the launch of the Ukrainian Pharmaceutical Agency, with key reform priorities fully aligned with EU approaches. She particularly emphasised the importance of transitioning from regulatory preparation to practical cooperation with EU Member States, including joint inspections, study visits, and knowledge exchange, which will strengthen the institutional capacity of the future regulator and support its integration into the European system.
   
   Background
   The Advisory Board was established to provide strategic guidance on the creation of the Ukrainian Pharmaceutical Agency in the pharmaceutical sector, bringing together recognised international and national experts, including:
   1. Emer Cooke — Executive Director of the European Medicines Agency (EMA);
   2. Lembit Rägo — MD, PhD, Secretary-General of the Council for International Organizations of Medical Sciences (CIOMS/WHO);
   3. Rainer Becker — Director for Medical Products and Innovation, Directorate-General for Health and Food Safety of the European Commission (DG SANTE);
   4. Krzysztof Landa — former Deputy Minister of Health of Poland;
   5. Robin Martz — Senior Program Manager for Health, U.S. Embassy in Kyiv;
   6. Mykhailo Radutskyi — Member of the Verkhovna Rada of Ukraine, Chair of the Parliamentary Committee on Public Health, Medical Assistance and Medical Insurance;
   7. Olha Stefanyshyna — Member of the Verkhovna Rada of Ukraine, Chair of the Subcommittee on the Adaptation of Ukrainian Legislation to EU Law;
   8. Anka Feldhusen — Business Ombudsperson;
   9. Petra Doerr — Director of the European Directorate for the Quality of Medicines & HealthCare (Council of Europe).