Strengthening Ukraine’s Pharmacovigilance System

From 23 to 27 March 2026, a high-level technical mission was successfully conducted in Kyiv under Activity 3.3 of the Twinning project “Support the Establishment of the State Control Authority for Medicines and Medical Devices.” This intensive week of collaboration focused on a critical objective: the full alignment of Ukraine’s pharmacovigilance (PhV) infrastructure with the rigorous safety standards of the European Union.

The mission was led by a distinguished panel of European regulatory experts, whose diverse backgrounds provided the Ukrainian State Expert Center (SEC) with a comprehensive view of EU best practices:

• Ms. Lina Seibokiene (Lithuania): Resident Twinning Adviser from the State Medicines Control Agency (SMCA), providing strategic oversight and ensuring the project’s alignment with the EU acquis.
• Mr. Petar Mas (Croatia): A specialist in Clinical Pharmacology from the Agency for Medicinal Products and Medical Devices (HALMED). As a Short-Term Expert, he shared Croatia’s successful transition and integration into the European safety network.
• Ms. Rasa Judickienė (Lithuania): A senior Pharmacovigilance Assessor from the SMCA’s Pharmacovigilance and Poison Information Unit, offering deep technical expertise in safety assessment and clinical trial monitoring.
• Ms. Lina Masionienė (Lithuania): Chief Specialist at the SMCA, specializing in the complex implementation and evaluation of risk minimization measures.

Practical Focus: Monitoring Safety Throughout the Lifecycle

The mission provided a deep dive into the practical methodologies used by EU regulators to protect patient safety. Key technical pillars included:

• Proactive Signal Management: Moving beyond simple data collection, experts demonstrated how to identify and validate safety "signals" using the EudraVigilance platform. Drawing on the Croatian experience—which successfully managed a surge of over 10,000 reports during the peak of the COVID-19 pandemic — the sessions illustrated how to maintain system integrity during public health crises.
• Advanced Assessment Procedures: Detailed workshops were held on the PSUR Single Assessment (PSUSA) and Risk Management Plans (RMPs). These sessions clarified how national authorities interact with the European Medicines Agency (EMA) to ensure that every medicine on the market maintains a positive benefit-risk balance.
• Safety in Clinical Trials: Under the framework of Regulation (EU) No 536/2014, experts trained Ukrainian counterparts on assessing SUSARs and Annual Safety Reports via the CTIS platform, ensuring international standards of transparency and ethics are upheld during drug development.
• Additional Risk Minimization (aRMMs): The team explored how to design and evaluate educational materials and controlled access programs, ensuring that safety information effectively reaches healthcare providers and patients.

Institutional Excellence and Organizational Design

A significant highlight of the mission was the exploration of a "Gold Standard" organizational blueprint for a modern pharmacovigilance department. Using the Croatian (HALMED) model as a primary reference, the experts presented a highly sophisticated departmental structure. This model features a specialized and robust team of assessors and coordinators, meticulously organized to oversee specific safety domains—from centrally authorized products to clinical trial monitoring. This strategic design serves as a vital template for Ukraine as it builds its own independent and effective State Authority.

Continuous Cooperation and Future Steps

The mission concluded with a strong affirmation of the partnership between Ukraine, Lithuania, and Croatia. Participants engaged in productive discussions regarding the roadmap for future activities, emphasizing a commitment to continuous cooperation. The project will maintain its momentum through regular technical exchanges via email, online consultations, and upcoming meetings, ensuring a seamless transition toward EU regulatory integration.

All materials presented during this activity are available here.