European integration in healthcare: key results of the year

In 2025, Ukraine continued its progress towards European integration in healthcare and pharmaceutical regulation. A number of important steps were taken during the year, ranging from the launch of new European instruments and programmes to the development of international cooperation and the preparation of systemic changes in regulation.

In 2025, Ukraine made significant progress in fulfilling its European integration commitments in the field of healthcare and pharmaceutical regulation. Among the main achievements of the year are:

• launch of the Twinning project to create a new regulatory body in the field of medicines and medical devices;
• conclusion of an agreement on Ukraine's accession to the EU joint procurement mechanism;
• cooperation with Sweden was initiated within the framework of an intergovernmental agreement on supporting European integration processes in pharmaceutical regulation;
• training tools were attracted from the European Medicines Agency - Instrument for Pre-Accession Assistance (IPA);
• three TAIEX missions were conducted in the areas of cosmetic products, biocides and substances of human origin (SoHO).

National Programme for the Adaptation of Legislation to EU Law was developed.

• memorandum on the formation of strategic pharmaceutical partnerships within the URC was signed.
• bilateral screening with the European Commission was completed.

Negotiation process with the European Union

Ukraine completed bilateral screening with the European Commission in a record time — as early as September 2025. Throughout the year, the Ministry of Health of Ukraine participated in bilateral meetings within a number of negotiating chapters, in particular the flagship Chapter 28 "Consumer Protection and Health Care," as well as in the areas of food safety, veterinary and phytosanitary policy, environment and climate change.

Among the key results is the acceleration of sectoral integration. In particular, the European Commission agreed to grant Ukraine access to the PEMSAC market surveillance platform for cosmetic products and responded positively to Ukraine's request to participate as an observer (on a one-time, ad hoc basis) in meetings of the competent authorities on biocidal products (Biocides CA meetings).

Following bilateral meetings, Ukraine joined in the formation of negotiating positions, all of which have now been approved by the Government. Thus, Ukraine is fully prepared to open negotiations with the EU on all Clusters.

At the same time, work is being completed on the National Programme for the Adaptation of Legislation to EU Law — a basic planning tool for all candidate countries for accession to the European Union.

Fulfilment of European integration commitments

In addition to strategic planning, in 2025 the Ministry of Health of Ukraine continued the practical implementation of European standards in the field of healthcare. During the year, the following were adopted:

• Strategy for the development of Ukraine's healthcare system until 2030;
• Strategy and action plan to combat antimicrobial resistance (AMR);
• Strategy for state drug policy until 2030 and operational plan for its implementation for 2025–2027;
• The Law on Mental Health, which enshrines the transition to a community-based care model;
• The roadmap for the implementation of Regulation (EC) No 883/2004 on the coordination of social security systems and Directive 2011/24/EU on the rights of patients in cross-border healthcare.

The European Commission also noted Ukraine's significant progress in fulfilling its European integration commitments under Chapter 28 in its latest EU Enlargement Report for 2025. Ukraine received a rating of ‘good progress’ — 4 points out of a possible 5.

Establishment of the State Regulatory Authority (SRA)

In 2025, the reform continued with the formation of a modern regulatory policy and the establishment of the State Regulatory Authority (SRA) — a single regulator that will grant market access and control the circulation of medicines, medical devices, substances of human origin, and cosmetic products.

A key milestone was the launch of the Twinning project with the support of the European Commission with a total budget of EUR 1.5 million. A consortium consisting of Lithuania, Poland and Germany (representatives from similar agencies in the EU) will assist the Ministry of Health in establishing a strict regulatory agency. The project aims to:

• harmonisation of legislation in the field of medicinal products, medical devices and cosmetics with EU law;
• institutional establishment and launch of the State Control Authority (SCA) as the central regulator at the pharmaceutical market;
• preparation and training of personnel to strengthen the capacity of the future authority.

Strategic partnership with the EU in the pharmaceutical sector

In 2025, Ukraine joined the Joint Procurement Agreement (JPA) for medical protection measures. This allows participating countries to combine their needs for the procurement of medicines, vaccines and other medical countermeasures, obtaining them faster, in stable volumes and on more favourable terms — especially in crisis situations. The JPA also opens up opportunities for our manufacturers, who can already be part of the supply chains for medicines in the EU, can be participants from outside. Ratification of the Agreement gives Ukraine the opportunity to influence price segments and the nomenclature within the framework of procurement by the European Union. This is because Ukraine, as a full participant in the JPA, will have its representative in the governing bodies of this agreement.

In addition, on the sidelines of URC-2025, a memorandum of cooperation was signed between the Ministry of Health, Ukrainian and foreign pharmaceutical businesses, which initiated a systematic dialogue on the formation of strategic partnerships in the production of critically important medicines with the involvement of European Union financial instruments.

In December 2025, this dialogue continued in Vilnius (Lithuania) during the conference "UA–EU: Strategic Partnership in the Pharmaceutical Sector," where Ukrainian pharmaceutical businesses presented their production potential and readiness to contribute to ensuring the sustainability of European drug supply chains.

Capacity building for healthcare professionals

During the year, Ukrainian healthcare professionals took part in three TAIEX missions in the areas of cosmetic products, biocides and substances of human origin (SoHO).

In 2025, Ukraine also gained access to the European Medicines Agency (EMA) EU Network Training Centre (EU NTC) as part of the Instrument for Pre-Accession Assistance III programme, which opens up new opportunities for systematic training and exchange of expertise.

In 2026, the Ministry of Health plans to further engage TAIEX tools in the areas of medical device evaluation, analysis of medicinal product registration dossiers, digitalisation of the healthcare system, cross-border medical care, and regulation of dietary supplements.

The Ministry of Health of Ukraine continues to work on the implementation of European standards in the field of healthcare and continues to actively cooperate with international partners.