Head of the Directorate for Expert Evaluation of Bioavailability and Bioequivalence Materials of the Center Nadiia Zhukova and expert of the division Oksana Nahorniak took part in the annual international conference on bioequivalence and bioavailability BioBridge 2024, held in Prague.
The event was devoted to the latest and expected regulatory changes. Our specialists were able to familiarize themselves with:
- the main provisions of the new ICH M13A guideline (this is the first of three planned parts of the new guideline on demonstrating bioequivalence within the process of harmonizing approaches to bioequivalence worldwide. The process is ongoing, and additional clarifications should be expected);
- with the draft vision of one of the sections of the second part of the ICH M13B guideline (approaches to conducting studies of substances with a narrow therapeutic index);
- the draft guideline on waiving in vivo studies for biosimilars and the draft updated guideline for inhaled medicinal products;
- the purpose and main provisions of the new ICH M15 guideline on the general principles of model-informed drug development.
Presentations were given by representatives of the EMA, regulatory medicines agencies of EU countries, international research organizations, and leading scientific institutions.
Other topical issues were also discussed during the conference: updating of specific bioequivalence guidelines, regulatory requirements for complex molecules, and approaches to over-the-counter products. Finally, the problems of applicants related to the differing approaches of a number of European agencies in assessing the scope of bioequivalence studies and the approaches to these studies were voiced.
