Specialists of the Center have developed the guideline “Medicinal products. Requirements for quality documentation for biological investigational medicinal products within clinical trials”. The document was approved by MoH order No. 1470 of September 22, 2025 https://surl.li/wtqxzn
The guideline sets out recommendations on special requirements for documentation on the biological and pharmaceutical quality of investigational medicinal products (IMPs) containing biological/biotechnological substances, submitted to obtain authorization to conduct a clinical trial / notification of substantial modifications to the dossier.
The provisions 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 when using biological investigational medicinal products in clinical studies;
- requirements for First in Human studies and confirmatory trials.
The new guideline complies with the provisions of the EMA guideline “Guideline on the requirements to quality documentation concerning biological investigational medicinal products in clinical trials” (2022) and has been adapted to the national regulatory framework.
You can read the new document on the official website of the Center at the link https://surl.li/ubyuot
