With the aim of harmonizing the regulatory framework of Ukraine on clinical trials of medicinal products on the basis of the European Union document: EMA/CHMP/BWP/534898/2008 Rev. 2 corr. "Guideline on the requirements to quality documentation concerning biological investigational medicinal products in clinical trials, 2022" ("Guideline on the requirements to quality documentation concerning biological investigational medicinal products in clinical trials, 2022"), specialists of the State Expert Center of the Ministry of Health of Ukraine have developed ST-N MoHU 42-9.2:2025 guideline "Medicinal products. Requirements to quality documentation concerning biological investigational medicinal products in clinical trials", approved by order of the Ministry of Health of Ukraine of 22.09.2025 No. 1470 (hereinafter – the Guideline), which defines recommendations on special requirements to documentation on biological and pharmaceutical quality of investigational medicinal products (hereinafter – IMPs) containing biological/biotechnological substances, which is submitted for obtaining authorization to conduct a clinical trial/notification of substantial modifications to the dossier on IMPs.
The provisions of the Guideline contain a description of:
- specific aspects of the production, quality control and stability of biological medicinal products;
- requirements for the description of the manufacturing process and the characteristics of batches;
- requirements for the description of the sources of the cell substrate, the establishment of the characteristics and the testing of cell banks of biological medicinal products;
- specific approaches to analytical and bioanalytical control;
- requirements for the comparability programme;
- benefit-risk assessment in the use of biological medicinal products in clinical trials;
- requirements for First in Human studies and confirmatory trials.
The new document can be reviewed on the official website of the State Expert Center of the Ministry of Health of Ukraine in the subsection "Guidelines" under the section "Regulatory Legal Acts" at the link.
