The guideline "Medicinal Products. General Considerations for Clinical Studies [ICH E8 (R1)]" has come into force in Ukraine.
In order to harmonize the regulatory framework in Ukraine on clinical studies of medicinal products, based on the European Union document: EMA/CHMP/ICH/544570/1998 "ICH guideline E8 (R1) on general considerations for clinical studies" 14 October 2021 (ICH Guideline E8 (R1) "General Considerations for Clinical Studies" of 14 October 2021), specialists of the State Expert Center of the Ministry of Health of Ukraine developed the guideline "Medicinal Products. General Considerations for Clinical Studies [ICH E8 (R1)]" ST-N MoHU 42–7.16:2025, approved by order of the Ministry of Health of Ukraine of 28.04.2025 No. 730, which addresses general aspects of clinical development, quality by design of clinical studies, taking into account a wide range of clinical study designs and data sources used.
The guideline includes:
- quality assurance in clinical studies;
- planning of medicinal product development throughout its life cycle;
- important elements of clinical study design used in medicinal product development, as well as the scope of available data sources;
- issues of study conduct, ensuring the safety of study participants and study reporting;
- considerations regarding the identification of factors that are critically important for study quality, etc.
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
