A bilateral meeting between the leadership of the Ministry of Health, with the participation of the Center, and the leadership of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of Poland is under way in Warsaw (28-30 November 2022).
Participants on the Ukrainian side included: First Deputy Minister of Health Oleksandr Komarida, Director of the State Expert Center Mykhailo Babenko, and Deputy Director for Registration and Pharmacovigilance Yevheniia Tkachenko.
The purpose of our participation is to establish bilateral cooperation and gain European experience in the expert evaluation of registration dossiers for medicinal products, clinical trials and HTA in order to improve the quality, safety and efficacy of medicinal products for patients in Ukraine.
The first day was devoted to the registration of medicinal products and medical devices in Poland. The Ukrainian delegation listened to presentations on the following topics:
- the Polish system of work in terms of registration of medicines, medical devices, and biocidal products;
- types of medicinal product registration procedures (EU centralized and national);
- the pharmacovigilance system in Poland;
- the main principles of work of the clinical trials department and other important issues.
The meeting is scheduled to include the signing of a Memorandum of Understanding between the State Expert Center and the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of Poland.
