As part of harmonization with European legislation, specialists of the State Expert Center of the Ministry of Health of Ukraine have developed the guideline ST-N MoHU 42–7.19:2026 "Medicinal products. Clinical trials of medicinal products for the treatment of epileptic disorders".
The document takes into account the new classification of the definition of types of epileptic seizures and epilepsy, approaches to confirming the efficacy of monotherapy, specific features of the development of medicinal products for use in pediatric practice, and other aspects of trials.
The guideline contains, in particular, recommendations on:
- selection of patients, choice of types of seizures and epileptic syndromes, assessment of efficacy criteria of medicinal products;
- design of clinical trials taking into account preclinical, pharmacological and therapeutic studies and safety aspects;
- conduct of studies involving pediatric patients and elderly patients.
The guideline ST-N MoHU 42–7.19:2026 was approved by order of the Ministry of Health of Ukraine No. 295 dated 06 March 2026.
The document was prepared in accordance with the European Union's CHMP/EWP/566/98 Rev.3 "Guideline on clinical investigation of medicinal products in the treatment of epileptic disorders" (September 2025).
The guideline is advisory in nature and will help improve the safety of clinical trials, adherence to ethical principles, and the introduction of new medicinal products into medical practice.
The text of the document can be found on the website of the State Expert Center of the Ministry of Health of Ukraine in the section "Guidelines and methodological recommendations on conducting preclinical and clinical trials".
