The guideline "Medicinal products. Preclinical studies of biodistribution of gene therapy medicinal products" has come into force in Ukraine.
In order to harmonize the regulatory framework in Ukraine for conducting preclinical studies of biodistribution of gene therapy medicinal products and on the basis of the European Medicines Agency (EMA) guidance "ICH S12 Guideline on nonclinical biodistribution considerations for gene therapy products", EMA/CHMP/ICH/318372/2021 – September 2023 (Guideline on nonclinical biodistribution considerations for gene therapy products – September 2023), specialists of the State Expert Center of the Ministry of Health of Ukraine developed the guideline ST-N MoHU 42–6.6:2024 "Medicinal products. Preclinical studies of biodistribution of gene therapy medicinal products", approved by order of the Ministry of Health of Ukraine of 23.10.2024 No. 1786.
The guideline addresses:
- timelines for conducting preclinical assessment of biodistribution;
- design of preclinical biodistribution studies;
- special considerations for the assessment of biodistribution of gene therapy medicinal products (products);
- application of preclinical biodistribution studies.
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
