The State Expert Center of the Ministry of Health of Ukraine and INFARMED – the National Authority of Medicines and Health Products of the Portuguese Republic – are launching practical cooperation in the regulation of medicinal products, medical devices and cosmetic products, which will become another step towards Ukraine's integration into the European regulatory space.
A Memorandum of Understanding was signed the other day by the Director of the Center Edem Adamanov and the President of INFARMED Rui Santos Ivo during a working visit of the Ukrainian delegation to Lisbon.
The document creates a basis for mutual exchange of knowledge and practical experience. Specialists of the Center will be able to study the approaches applied by the regulator of an EU member state. This is especially important now, when Ukraine is undergoing a large-scale transformation of the pharmaceutical sector and preparing for further integration into the European regulatory space. At the same time, Portuguese colleagues are interested in the Ukrainian experience of ensuring continuity of regulatory processes, maintaining institutional resilience and expert potential under conditions of war and large-scale changes.
We agreed to develop cooperation and exchange practical experience in the following areas:
- state registration of medicinal products;
- clinical trials;
- inspection;
- health technology assessment;
- pricing;
- pharmacovigilance;
- regulation of medical devices and cosmetic products.
"For us, this cooperation is not about a formal exchange of documents. INFARMED has been working under European rules for over 30 years and has extensive practical experience in the areas that are priorities for Ukraine today: state registration of medicinal products, clinical trials, pharmacovigilance, inspection, health technology assessment and pricing. Our task is not simply to adopt this experience, but to use it to improve the work of the Center: to make processes clearer, to strengthen expert capacity and to implement modern European approaches. All of this is needed for one thing – so that decisions on the quality, safety and efficacy of medicinal products are made on the basis of best practices and serve the interests of the patient," noted the Director of the Center, Edem Adamanov.
The practical value of the cooperation lies not only in familiarising ourselves with regulatory documents, but also in jointly working through how regulatory requirements are applied in day-to-day work. For both institutions, this is an opportunity to strengthen institutional capacity, improve procedures and exchange solutions that have proven effective in different conditions.
After the Memorandum was signed, meetings of specialists from the two institutions took place. The parties presented the structure of their agencies, their powers, areas of responsibility and key areas of work. Based on the results of the discussions, they identified priorities for cooperation and outlined a plan for further action.
Ahead are expert consultations, thematic seminars, working visits and regular exchange of information. It is precisely such formats of cooperation that will help strengthen the institutional capacity of both institutions and implement decisions that work in the interests of patients.
For reference. INFARMED is the national regulator of Portugal in the field of medicinal products, medical devices and cosmetic products and a participant in the European regulatory network for medicinal products since 1993.
