The First Steering Committee Meeting of the Twinning Project on Establishing a State Control Authority for Medicines and Medical Devices

On 29 October 2025, the first (inception) meeting of the Steering Committee of the Twinning project “Support the Establishment of the State Control Authority for Medicines and Medical Devices” was held. The meeting took place in a hybrid format, hosted by the Ministry of Health of Ukraine and online, with the participation of representatives of EU Member States, the EU Delegation, and the Ukrainian authorities.

The meeting marked the official launch of the project implementation and aimed to establish a common understanding of objectives, agree on implementation approaches, and endorse key organisational and procedural arrangements necessary for the effective delivery of the Twinning project.

Project Structure and Implementation Logic

During the meeting, the Initial Work Plan for the period October 2025 – April 2026 was presented and discussed, including its structure, scope, sequencing of activities, and the interlinkages between project components.

The Twinning project is structured around three interrelated components, which define its overall content, implementation logic, and expected results:

• Component 1 – alignment of the Ukrainian legal and regulatory framework with the EU acquis;
• Component 2 – definition of the organisational structure and operational parameters of the new regulatory authority;
• Component 3 – support for institutional capacity building of the new authority, in line with EU best regulatory practices.

It was confirmed that project results will be achieved through the implementation of coherent and mutually reinforcing activities under each component, while progress will be assessed based on indicators and sources of verification defined in the project documentation.

Priorities of the Initial Implementation Phase

The Ukrainian side outlined a key methodological priority for the initial phase of the project: prioritising reviews of documents, systems and procedures (including guidelines, SOPs and regulatory practices) before conducting practical training activities. This approach is intended to ensure full alignment of future training with EU standards and the actual needs of the beneficiary institutions.

The Steering Committee agreed that the principle of “review first, training second” would be applied across all components, without affecting their distinct scope or logic.

Activity Calendar and Organisational Arrangements

The Steering Committee reviewed and approved the short-term activity calendar for Q4 2025 – Q1 2026. It was agreed that each activity would be preceded by a short scoping call between the relevant EU Member State experts and the Ukrainian team to уточнити objectives, scope and expected outputs.

Special attention was paid to communication and visibility matters. The draft Visibility and Communication Plan was presented and endorsed in principle, subject to incorporation of comments from the Ukrainian side and subsequent written approval.

Special Implementation Arrangements

In view of the security situation in Ukraine, the possibility of implementing certain missions in designated “hubs” in EU Member States, in particular Lithuania and Poland, was confirmed. Relevant adjustments will be reflected in the Work Plan and related organisational documents.

Clarifications were also provided regarding the financial principles of project implementation in line with Twinning rules, including expert remuneration, per diems and reimbursement of costs.

Next Steps

Based on the outcomes of the meeting, the Steering Committee:

• endorsed the Work Plan in principle, subject to further refinement of specific elements;
• approved the activity calendar for the initial phase of implementation;
• confirmed the use of EU Member State hubs under special conditions;
• agreed that the next Steering Committee meeting would take place on 28 January 2026 in Vilnius.

“The first Steering Committee meeting laid the institutional and methodological foundations for the further implementation of the Twinning project and confirmed the shared commitment of Ukraine and EU Member States to building an effective, independent, and EU-oriented system for the regulation of medicinal products and medical devices,” said Maryna Slobodnichenko, Deputy Minister of Health for European Integration.