This week the Center submitted more than 220 recommendations to the Ministry of Health of Ukraine in the area of state registration of medicinal products in Ukraine.
Based on the results of the expert review of registration materials for medicinal products and clinical trials, by decision of the meeting of the Scientific and Technical Council of the Center of 22.08.2024, the Ministry of Health of Ukraine was recommended to:
- for re-registration – 13 medicinal products (of which 12 – for an unlimited period)
- to registration of substances – 3
- to re-registration of substances – 2
- introduction of amendments to the registration materials for medicinal products (regarding quality, safety/efficacy and pharmacovigilance, administrative and other changes) – 184
- to withdrawal from consideration at various stages of expert evaluation (at the applicant's request) – 4 medicinal products
- amendments to the protocols of international multicentre clinical trials of medicinal products – 10.
