This week, based on the results of the meetings of the Scientific Expert and Scientific and Technical Councils of 11 April 2024, the Center recommended to the MoH of Ukraine:
- for state registration – 12 medicinal products (7 foreign and 5 domestic manufacture) – analgesics, antibiotics, antitumor drugs, products for the treatment of diseases of the throat and nose, hereditary angioedema, emergency contraceptives;
- for registration of APIs – 1;
- for re-registration – 16 medicinal products ;
- for re-registration of APIs – 3;
- amendments to registration materials (regarding quality, safety/efficacy and pharmacovigilance, administrative, etc.) – 185 medicinal products;
- to the approval of protocols of international multicenter/domestic clinical trials of medicinal products – 4;
- amendments to the protocols of international multicentre clinical trials of medicinal products – 16.
- for deregistration – 7 medicinal products
- until withdrawal of amendments to the registration materials – 12
- not recommended for re-registration – 1.
The list of protocols on the registration/re-registration of medicinal products, as well as on making changes to the registration dossier materials, will be published on the Center’s website after the relevant decisions are made by the Ministry of Health.
