Strengthening Capacity in Donor Blood Procurement and Testing under the EU–UA Twinning Project

Between 15 and 22 December 2025, a series of technical meetings and a virtual laboratory visit were held within the framework of the EU–UA Twinning Projec “Support the Establishment of the State Control Authority for Medicines and Medical Devices”. The activities were implemented under Activity 3.11 (Strengthening SCA staff capacity in procurement and testing of donor blood and its components), focusing on strengthening the institutional capacity of Ukrainian authorities in the procurement, testing, and regulation of donor blood and blood components.

The mission brought together experts from the National Blood Center of Lithuania and representatives of the Ukrainian health and blood system authorities. The discussions combined regulatory analysis, technical exchange, and practical demonstrations, aiming to align Ukrainian practices with EU standards and emerging regulatory frameworks.

Focus of the Mission

The mission addressed key aspects of the blood system, including laboratory testing of donor blood, procurement and distribution mechanisms, licensing and inspection models, donor eligibility and safety safeguards, and ethical principles governing materials of human origin. Particular attention was given to comparing Ukrainian practices with those applied in EU Member States, notably Lithuania, and to identifying gaps requiring further regulatory or procedural adjustments.

Lithuanian experts introduced EU approaches to blood system governance, including the upcoming Regulation (EU) 2024/1938 on substances of human origin (SoHO), which will enter into force in 2027. The importance of early preparation for this Regulation was underlined, given its horizontal application to blood and other materials of human origin and its emphasis on quality, safety, and non-profit principles.

Regulatory Review and Gap Analysis

During the meetings, Ukrainian regulatory documents related to blood collection, testing, storage, procurement, and licensing were reviewed. An initial gap analysis was conducted against EU and Lithuanian legislation, focusing in particular on:

• procedures for screening donor blood and blood components for transfusion-transmissible infections;

• organisation of procurement and distribution systems;

• licensing models and inspection practices for blood establishments.

The experts noted that the Ukrainian blood procurement system is well established and operates on a demand-and-supply logic coordinated at national level. At the same time, recommendations were formulated to further align procurement mechanisms with EU ethical and regulatory principles, especially in view of the future SoHO framework.

Laboratory Testing and Practical Training

A key element of the mission was a virtual tour of the laboratory at the National Blood Center of Lithuania, which provided Ukrainian specialists with practical insight into immunohematology, serology, and molecular (NAT) testing. The laboratory organisation, quality management systems, accreditation practices, GMP requirements, and cooperation with plasma fractionators were presented and discussed in detail.

The exchange highlighted that, while EU legislation does not prescribe a single mandatory laboratory testing algorithm, the use of highly sensitive and reliable methods, clear terminology, and robust quality control systems is essential. Lithuanian experts confirmed that written technical feedback and proposed amendments to Ukrainian procedures would be provided following the mission.

Outcomes and Next Steps

As a result of the mission, Ukrainian specialists received targeted training on EU-aligned procurement and testing standards, reviewed existing SOPs and checklists, and gained practical exposure to EU laboratory practices. The Lithuanian side committed to delivering written analytical feedback, technical comments, and translated inspection-related materials.

Further technical meetings and potential on-site activities are planned to continue the dialogue, support regulatory updates, and ensure a consistent transition towards EU standards in the blood and blood components sector.

The mission confirmed the strong commitment of both Ukrainian and EU partners to enhancing blood safety, quality, and regulatory coherence as part of the broader reform of the state control system for medicines and medical devices.