The representatives of the State Service of Ukraine on Medicines and Drugs Control took part in the training upon European Medicines Agency’s invitation
Опубліковано 09.10.2025 о 14:39The representatives of the State Service of Ukraine on Medicines and Drugs Control with the support of WHO, participated in the EMA training course “Strengthening the regulatory capacity of candidate countries” within the framework of Instrument for Pre-Accession Assistance (IPA). The event took part in Montenegro, in Podgorica on 2-3 October 2025 at the Institute of Medicines and Medical Devices of Montenegro and brought together the representatives of national competent authorities.
The speakers from the Federal Institute on Medicines and Medical Devices (Germany), the Agency for Health and Food Safety (Austria), and European Medicines Agency familiarized the participants with decision-making procedures and the principles of benefit-risk balance assessment and presented European experience in regulatory responses to the challenges.
The representatives of the State Service actively participated in group exercises analyzing case studies, presented the results of their work, and exchanged experience with colleagues from other countries. The obtained knowledge will be used to improve national regulatory practices, increase the effectiveness of medicines control, and contribute to the harmonization of Ukrainian legislation with European standards, which is an important step in Ukraine’s European integration process. Building regulatory capacity is a strategic foresight for harmonizing standards to ensure further integration.
For reference. The Instrument for Pre-accession Assistance (IPA) is the financial means by which the EU has been supporting reforms in the enlargement process of the candidate country throughout the accession process.
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