Based on the results of the expert review of registration materials for medicinal products regarding their re-registration, amendments, and amendments to clinical trial protocols, by the decision of the scientific expert council of 04 April 2024, the Center recommended to the Ministry of Health of Ukraine:
- for re-registration in Ukraine for an unlimited term – 9 medicinal products
- before registration of APIs – 1
- for re-registration of APIs – 2
- amendments to registration materials (regarding quality, safety/efficacy and pharmacovigilance, administrative, etc.) – 153 medicinal products
- for withdrawal from consideration – 1 (API)
- for withdrawal of amendments to the registration materials from consideration – 20 (3 – at the applicant's request, 17 – due to failure to provide responses to the Center's comments within the period established by legislation)
The decision of the NTR also recommended making amendments to 20 protocols of international multicenter clinical trials of medicinal products.
Summary data in the table:
