July 2026 was rich in continued cooperation between the Center and European regulators within the framework of the international technical assistance project Twinning.
At the State Expert Center, a series of practical trainings was held by leading European experts and international consultants of the project, aimed at implementing the best EU regulatory practices, enhancing the institutional capacity of the State Expert Center and deepening the competence of specialists for work in the new state control body – the Ukrainian Pharmaceutical Agency.
During the consultative meetings and practical workshops, our experts considered the following issues:
- pharmacovigilance and methodology for the assessment of periodically updated safety reports for medicinal products (PSUR) – approaches to signal assessment, benefit/risk analysis, assessment of post-authorisation exposure, specific features of assessment for generic medicinal products, EU practice in organising expert evaluation and adopting regulatory decisions.
The mentor of the track was a leading specialist in clinical pharmacology of the Agency for Medicinal Products of Croatia (HALMED), Petar Mas;
- the procedure for registration and expert evaluation of medicinal products in accordance with EU requirements – analysis and legal consultations on legislation regarding market authorisation of medicinal products in accordance with EU requirements, in particular on matters of proving bioequivalence. Particular attention was paid to the experience of how these processes function in the countries of the European Union and ways to improve them in Ukraine in the context of creating a future single state control body.
Strategic recommendations were shared by the project's permanent adviser Lina Seibokene and Daumantas Gatauskas, expert, director of the National Blood Center of Lithuania.
- good laboratory practice (GLP) – improved professional knowledge on GLP and mutual acceptance of data (MAD) of the Organisation for Economic Co-operation and Development (OECD) and became more closely acquainted with the Polish national programme for monitoring compliance with GLP principles.
Their experience and control algorithms were shared with Ukrainian specialists by Monika Guzera, quality manager of the National Institute of Medicinal Products of Poland, Mariusz Godala, director of the Department of Good Laboratory Practice of the Bureau of Chemical Substances.
The knowledge gained, recommendations and practical cases received from international partners will not only enhance the competencies of the Center's expert staff but also ensure the practical implementation of the requirements for Ukraine's EU membership in the regulatory sphere.
Let us recall that the Twinning initiative in the pharmaceutical sector of Ukraine was launched in October 2025 as a tool to support European integration reforms and build a modern, competent regulatory authority that meets EU standards in the field of registration, quality control and safety of medicinal products. It is being implemented with the full support of the European Commission and in close partnership with a consortium of leading regulatory authorities of EU member states: Lithuania, Poland and Germany.
