About 300 recommendations in the field of medicinal product registration and clinical trials in Ukraine – results of the NER and NTR meetings of the Center of February 08, 2024.
Based on the expert review of registration materials for medicinal products, by decision of the Center’s Scientific Expert Council, 17 medicinal products were recommended for registration in Ukraine this week – 6 of domestic and 11 of foreign manufacture. Among them are antiseptic, mucolytic, antihistamine, anti-inflammatory, antibacterial, antifungal products, products used in ophthalmology, and others.
The Ministry of Health is also recommended to approve the conduct in Ukraine of 4 international multicenter clinical trials of medicinal products. These include, in particular, products for use in psychiatry and oncology.
By decision of the Scientific and Technical Council of the Center, it is recommended:
- for re-registration for an unlimited period – 15 medicinal products
- registration of substances – 3
- to re-registration of substances – 2
- amendments to registration materials (regarding quality, safety/efficacy and pharmacovigilance, administrative, etc.) – 237 medicinal products
- introduction of amendments to protocols of international multicentre clinical trials of medicinal products – 20
