The guideline "Medicinal Products. Clinical Trials of Medicinal Products for the Treatment of Arterial Hypertension" has come into force in Ukraine.
In order to harmonize the regulatory framework in Ukraine on clinical trials of medicinal products for the treatment of arterial hypertension, and on the basis of European Union documents: EMA/CHMP/29947/2013/Rev. 4, 2016 "Guideline on clinical investigation of medicinal products in the treatment of hypertension", EMA/CHMP/206815/2013, 2015 "Paediatric addendum to the note for guidance on the clinical investigation on medicinal products in the treatment of hypertension", specialists of the State Expert Center of the Ministry of Health of Ukraine have developed the guideline "Medicinal Products. Clinical Trials of Medicinal Products for the Treatment of Arterial Hypertension" ST-N MoHU 42–7.15:2024, approved by order of the Ministry of Health of Ukraine dated 13.11.2024 No. 1903, which contains recommendations on the planning of clinical trials that are considered important for the evaluation of new original antihypertensive medicinal products.
The guideline includes:
- methods for evaluating the efficacy of new antihypertensive medicinal products;
- patient selection, study design and aspects of the safety of use of the investigational antihypertensive medicinal products;
- study of fixed-dose combination in the treatment of arterial hypertension;
- current issues regarding the use of fixed combinations of antihypertensive medicinal products in second-line therapy;
- clinical trials of medicinal products for the treatment of hypertension in the pediatric population.
The text of the new 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 for conducting preclinical and clinical trials" at the link
