On 31 December 2025, the Center hosted the last pre-New Year meetings of the Scientific Expert Council and the Scientific and Technical Council, chaired by Director Mykhailo Babenko and Deputy Director for Registration and Audit Olena Semenchenko. Based on the results, the Ministry of Health of Ukraine was provided with 344 expert recommendations in the field of state registration of medicinal products and clinical trials. Namely:
- in the field of state registration of medicinal products:
- for registration – 7 medicinal products and 3 APIs
- for re-registration – 10 medicinal products and 7 APIs
- introduction of changes to registration materials – 299 medicinal products
- for withdrawal from consideration of registration materials at the stages of expert evaluation – 3
- in the field of clinical trials:
- for approval of international multicentre clinical trials – 1
- amendments to the protocols of international multicentre clinical trials of medicinal products – 7.
In total, during 2025, the Center held 31 meetings of the Scientific Expert Council and 48 meetings of the Scientific and Technical Council. Based on the results, more than 11 400 expert conclusions were provided to the relevant ministry.
Among the key recommendations:
- to register in Ukraine – almost 300 medicinal products and 66 substances
- to re-register – more than 350 medicinal products and 100 APIs
- amend registration materials – for more than 9,5 thousand medicinal products
- authorize the conduct of 80 clinical trials by both international and domestic sponsors.
- amend more than 670 clinical trial materials.
The results demonstrate the high intensity and responsibility of the Center's expert activity. This work will be consistently continued in 2026 as well – to ensure the uninterrupted supply of quality, effective and safe medicinal products to patients and the sustainable functioning of Ukraine's healthcare system.
