As part of harmonization with European legislation, specialists of the Directorate for Expert Evaluation of Bioavailability and Bioequivalence Materials of the Center have developed a Guideline that defines provisions on bioequivalence studies of medicinal products under the biowaiver procedure based on the Biopharmaceutics Classification System.
The new Guideline contains:
- updated requirements for determining the solubility and permeability of the active substance to confirm the class according to the Biopharmaceutics Classification System;
- updated requirements for excipients;
- updated requirements for in vitro dissolution.
Guideline ST-N MOZU 42-7.5: 2023 approved by MoH of Ukraine order No. 207 of February 07, 2024.
Prepared in accordance with the Guideline on biowaivers based on the biopharmaceutics classification system (EMA/CHMP/ICH/493213/2018 “ICH M9 guideline on biopharmaceutics classification system-based biowaivers”) of the European Medicines Agency.
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
