Based on the results of the review of registration materials for medicinal products submitted to the Center for the purposes of their state registration, re-registration, amendment, and of clinical trial materials, by decision of the Scientific Expert and Scientific and Technical Councils of the Center of 09.01.2025, 288 recommendations were submitted to the MoH of Ukraine:
- for registration – 6 medicinal products (3 – foreign, 3 – domestic production) and 2 APIs
- before re-registration – 14 medicinal products and 5 APIs
- amendments to registration materials (concerning their quality, safety/efficacy and pharmacovigilance, administrative and other changes) – 229 medicinal products
- to removal from the registration procedure (due to failure to respond to remarks within the period established by legislation) – 1 medicinal products
- until the registration materials were withdrawn from consideration at the expert evaluation stages – 6 medicinal products.
Amendments to protocols of international multicenter clinical trials for 19 medicinal products were also recommended.
