Second Twinning Steering Committee Meeting: Results of the Initial Phase and Priorities for Further Project Implementation

On 28 January 2026, the second meeting of the Steering Committee of the Twinning project “Support to the Establishment of a State Authority for Medicines and Medical Devices Control” was held. The meeting took place in a hybrid format, combining an on-site session in Vilnius with online participation, and brought together representatives of EU Member States, the EU Delegation, and the Ukrainian authorities.

The Twinning project is structured around three core components, which define its overall scope, implementation logic, and expected results. During the meeting, the Steering Committee reviewed the implementation of Work Plan 1 (WP1), assessed the results achieved to date, and agreed on the priorities and next steps under Work Plan 2 (WP2), in line with the project documentation and the Logical Framework Matrix.

The project focuses on the following components:

• Component 1 – Alignment of Ukraine’s regulatory and legal framework with European Union legislation and standards;

• Component 2 – Definition of the organisational structure and operational parameters of the new regulatory authority;

• Component 3 – Support for strengthening the institutional capacity of the new regulatory authority through modern methodologies in line with EU best regulatory practices.

Achievement of project results is ensured through the implementation of a set of interrelated activities under each component. Progress is measured using objectively verifiable indicators defined in the project’s Logical Framework Matrix.

Results of Work Plan 1 implementation

The initial phase of the Twinning project focused on the launch of activities and the establishment of a solid operational framework for further cooperation.

Ukrainian priorities for the first half of Work Plan 1

The Ukrainian side identified priority areas considered essential for building a new regulatory system and ensuring the stable functioning of the market, including:

• marketing authorisation of medicinal products;

• pharmacovigilance;

• GMP/GDP inspections;

• market surveillance of medical devices;

• procurement and testing of donor blood and blood components;

• extemporaneous preparation of medicinal products.

Several activities in these areas are already in the active implementation phase, while others are scheduled to commence between February and May 2026, in accordance with the agreed priorities and the phased approach to reform.

Key results achieved

GMP/GDP inspections
Within WP1, a deeper understanding of EU-compliant inspection systems was achieved. Requirements related to inspector qualifications, inspection planning and certification were clarified, and the inspection system’s capacity to identify and adequately respond to serious GMP/GDP non-compliance was strengthened. Practical guidance (GMP GDP) was provided on the use of IRIS (the EU platform for regulatory data submission and processing) and EudraGMDP.

Medical devices (MDR/IVDR)
Legislative changes required for alignment with EU requirements were identified. National competences in the areas of market surveillance, vigilance and enforcement were defined, and a gap analysis of national legislation was conducted, together with possible options for addressing identified shortcomings.

Procurement and testing of donor blood
A comparative analysis of procurement, testing and licensing procedures against EU requirements was carried out. Key ethical principles for harmonisation with EU standards were identified, and recommendations were developed to improve screening procedures and quality control of donor blood.

Alignment with the EU acquis
A comparative assessment of Ukrainian legislation against EU law was completed. Priority legal acts requiring revision were identified, and an Action Plan for legislative harmonisation for February–April 2026 was approved.

Priorities under Work Plan 2

The Steering Committee approved WP2 in general and confirmed its key priorities. Particular emphasis was placed on Component 2, which is critical for the establishment of the new regulatory authority and includes:

• development of the organisational structure;

• preparation of internal policies, including policies on the prevention and management of conflicts of interest;

• design of a remuneration system and staff incentive mechanisms.

Next steps

The next Steering Committee meeting is scheduled for 22 April 2026 and will be held in Warsaw.

“The second Steering Committee meeting confirmed the stable and predictable progress of the Twinning project and the shared commitment of all parties to achieving concrete and measurable results. Ukraine, in partnership with Lithuania, Poland, and Germany, and with the support of the European Commission, is consistently building an effective, independent, and EU-oriented system for the regulation of medicines and medical devices. Twinning remains one of the key instruments supporting Ukraine in the implementation of EU regulatory approaches and in strengthening trust among market actors and international partners.”
 — Maryna Slobodnichenko, Deputy Minister of Health of Ukraine for European Integration, concluded.