The guideline "Medicinal products. Preclinical studies of carcinogenicity of medicinal products" has come into force in Ukraine.
In order to harmonize the regulatory framework in Ukraine regarding medicinal products requiring carcinogenicity testing, and on the basis of the European Medicines Agency (EMA) guideline on experimental approaches to the assessment of the carcinogenic potential of medicinal products – EMA/774371/2022 "ICH guideline S1B(R1) on testing for carcinogenicity of pharmaceuticals", — March 2023 (Guideline on testing for carcinogenicity of pharmaceuticals, — March 2023), specialists of the State Expert Center of the Ministry of Health of Ukraine have developed the guideline "Medicinal products. Preclinical studies of carcinogenicity of medicinal products" ST-N MoHU 42–6.4:2024, approved by order of the Ministry of Health of Ukraine dated 07.05.2024 No. 790 "On amendments to the order of the Ministry of Health of Ukraine dated 16 February 2009 No. 95", according to which an amendment was made to paragraph 1 of the order of the Ministry of Health of Ukraine dated 16 February 2009 No. 95 "On approval of documents on quality assurance of medicinal products", supplementing it with a new subparagraph as follows:
"1.18. "Guideline "Medicinal products. Preclinical studies of carcinogenicity of medicinal products" ST-N MoHU 42-6.4:2024" (attached), is introduced for the first time, recommended for use by business entities".
The guideline defines:
- choice of strategy, approach to the study of carcinogenic potential, and animal species for a long-term carcinogenicity study;
- assessment of carcinogenic potential;
- approaches to the use of mechanistic studies;
- weight-of-evidence approach for assessing the carcinogenic potential of medicinal products for humans
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
