The guideline “Medicinal products. Detection of reproductive toxicity of medicinal products for medical use” has come into force in Ukraine.
In order to harmonize the regulatory framework in Ukraine regarding the assessment of preclinical studies of developmental toxicity (ontogenetic toxicity) and reproductive toxicity (DART) required to support clinical trials of medicinal products in humans and their subsequent registration, and on the basis of the guideline of the European Medicines Agency (EMA) on the detection of reproductive toxicity of medicinal products for human use: “ICH S5 (R3) guideline on reproductive toxicology: Detection of toxicity to reproduction for human pharmaceuticals”, EMEA/CHMP/ICH/544278/1998, February 2020), specialists of the State Expert Center of the Ministry of Health of Ukraine developed and published the guideline “Medicinal products. Detection of reproductive toxicity of medicinal products for human use” ST-N MOZU 42–6.3:2023, approved by MoH of Ukraine order of 18.12.2023 No. 2134.
The guideline defines:
- general considerations regarding the assessment of reproductive toxicity;
- design and evaluation of in vivo studies in mammals;
- choice of test system, dose level, route of administration, and dosing regimen;
- possible combined study designs in rodents, etc.
You can read the text of the new document on the website of the State Expert Center of the Ministry of Health of Ukraine in the section “Guidelines” at the link
