The Center submitted to the MoH 245 expert recommendations on medicinal products and clinical trials – results of the Scientific Expert Council/Scientific and Technical Council meetings of 06 February 2025.
Based on the review of registration materials for medicinal products under the procedures of their state registration, re-registration and amendment, by the decision of the Scientific Expert Council and the Scientific and Technical Council of February 06, 2025, the Ministry of Health was recommended to:
- before registration in Ukraine – 4 medicinal products (products used in the treatment of oncological diseases and diseases of the nervous system) and 1 APIs;
- for re-registration – 6 medicinal products
- to amendments to registration materials (regarding their quality, safety/efficacy and pharmacovigilance, administrative, other changes) – 219 medicinal products
- withdrawn from the registration procedure (due to failure to respond to comments within the period established by law) – 1 medicinal products
- before withdrawal from consideration at the expert evaluation stages (at the applicant's request) – 1 medicinal products.
In the area of clinical trials of medicinal products, it is recommended to:
- introduction of amendments to the protocols of international multicenter CTs – 11
- approval of the program for access of study subjects to the investigational medicinal product after completion of the CT – 1.
