The guideline ST-N MoHU 42-7.6:2026 "Medicinal products. Validation of a bioanalytical method and analysis of study samples (ICH M10)" has come into force in Ukraine.
The document establishes approaches to conducting bioanalytical studies and assessing the reliability of their results that are aligned with international practice.
The guideline was developed by specialists of the State Expert Center of the Ministry of Health of Ukraine and approved by order of the Ministry of Health of Ukraine No. 923 of 10 July 2026.
The document is based on the EMA/CHMP/ICH/172948/2019 guidance "ICH guideline M10 on bioanalytical method validation and study sample analysis" and is adapted and harmonized with the legislation of Ukraine.
Bioanalytical methods are used to determine the concentration of active substances and their metabolites in biological samples during preclinical and clinical studies.
The data obtained are used to assess the pharmacokinetics, bioavailability and bioequivalence of medicinal products, as well as the reliability of the results submitted as part of registration materials.
The guideline contains recommendations on:
- validation of bioanalytical methods;
- analysis of study samples;
- documentation and evaluation of the results obtained;
- ensuring their accuracy, reliability and reproducibility.
The document is intended for applicants, holders of registration certificates, developers and manufacturers of medicinal products, research institutions, expert and regulatory authorities.
Compliance with the provisions of the guideline will contribute to the harmonization of Ukrainian approaches with international practice, improvement of the quality of bioanalytical studies, consistency of the expert evaluation of registration materials and the adoption of well-founded regulatory decisions on medicinal products.
For patients, this means strengthening the reliability of the evidence base on which medicinal products are assessed.
You can read the text of the guideline
PDFat the linkPDF · 1.2 MB
