This week the Center provided the Ministry of Health of Ukraine with recommendations on 444 items of medicinal products and clinical trials – results of the NER/NTR meetings of 14.03.2024.
Thus, in particular, following the expert evaluation of registration materials submitted for state registration, re-registration, and amendments, and of clinical trial materials for medicinal products, the decisions of the Scientific Expert and Scientific Technical Councils of the Center recommended:
- for registration in Ukraine – 13 medicinal products and 4 substances
- for re-registration – 18 medicinal products and 4 substances
- amendments to registration materials – for 374 medicinal products
- for approval – conducting 1 international multicenter clinical trial of a medicinal product
- making amendments to 30 protocols of international multicenter clinical trials of medicinal products
The NER and NTR meetings were held under the guidance of the Center's Deputy Director for Registration and Pharmacovigilance Yevheniia Ishkova (Tkachenko).
