On February 26, the 3th International Conference on Bioequivalence (3rd Bioequivalence Conference) was held in Amsterdam (Netherlands). The event was held with the support of the International Generic and Biosimilar medicines Association (IGBA) and Medicines for Europe. The focus was on discussing updated requirements for demonstrating bioequivalence with the aim of harmonizing regulatory standards worldwide.
Representing the Center at the conference were Nadiia ZHUKOVA, Head of the Department for Evaluation of Bioavailability and Bioequivalence Materials, and Oksana NAHORNIAK, expert of the Division for Evaluation of Materials on Generic and Other Medicinal Products.
The following topics were discussed during the event:
- International harmonization of bioequivalence: current status and next steps (implementation of ICH M13A and topical issues of M13C)
- Use of model-based forecasting in the development of generic medicinal products
- Compliance and oversight in the field of bioequivalence
- A single global development of generic medicinal products: ensuring patient access.
Open discussions and exchanges took place between representatives of regulatory authorities, scientists, researchers and manufacturers of medicinal products.
The information obtained will make it possible to understand the prospects for the development of approaches to bioequivalence studies worldwide.
The knowledge gained will be used to train experts and applicants and to develop regulatory legal acts in order to facilitate the integration of Ukraine into the EU regulatory systems, the Acquis Communautaire.
We remind you that on January 25, 2025, the Guideline on the evidence of bioequivalence ICH M13A – EMA/CHMP/ICH/953493/2022 "ICH M13A Guideline on bioequivalence for immediate release solid oral dosage forms" came into force. It defines the requirements for planning, conducting and evaluating bioequivalence studies of immediate-release dosage forms with systemic action. ICH M13A aims to harmonize the requirements for conducting bioequivalence studies in different regions of the world, minimizing the need for repeat studies and facilitating a more efficient regulatory assessment.
