Biomarker-Driven Developments in the Context of the New Regulatory Framework for Companion Diagnostics in the European Union.

Autor: Verbaanderd C; PhaRA Consulting, Antwerp, Belgium., Trullás Jimeno A; European Medicines Agency, Amsterdam, The Netherlands., Engelbergs J; Paul Ehrlich Institute, Langen, Germany., Zander H; Paul Ehrlich Institute, Langen, Germany., Reischl I; Austrian Agency for Health and Food Safety, Wien, Austria., Moreno Oliver A; Spanish Agency for Medicines and Health Care Products, Madrid, Spain., Vamvakas S; European Medicines Agency, Amsterdam, The Netherlands., Vleminckx C; European Medicines Agency, Amsterdam, The Netherlands., Bouygues C; European Medicines Agency, Amsterdam, The Netherlands., Girard T; European Medicines Agency, Amsterdam, The Netherlands., Day F; European Medicines Agency, Amsterdam, The Netherlands., Frias Z; European Medicines Agency, Amsterdam, The Netherlands.
Jazyk: angličtina
Zdroj: Clinical pharmacology and therapeutics [Clin Pharmacol Ther] 2023 Aug; Vol. 114 (2), pp. 316-324. Date of Electronic Publication: 2023 May 25.
DOI: 10.1002/cpt.2928
Abstrakt: The new In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR) introduces important changes in the EU legal framework for companion diagnostics (CDx), including a new risk-based classification system for in vitro diagnostic tests (IVDs), a first legal definition for CDx and enhanced involvement of notified bodies in the conformity assessment and certification process of CDx. The IVDR also establishes an important link between the assessment of a CDx and the corresponding medicinal product by requiring the notified body to seek a scientific opinion from the medicines regulator on the suitability of the CDx for use with the concerned medicinal product(s) before issuing an IVD certificate. Whereas the IVDR aims at establishing a robust regulatory framework for IVDs, it is also associated with several challenges, such as insufficient capacity of notified bodies and readiness of manufacturers. To ensure timely access for patients to essential IVDs, a progressive roll-out for this new legislation has been introduced. In addition, the new consultation process for CDx requires increased collaboration and alignment of assessments performed by the different stakeholders involved in this process. The European Medicines Agency (EMA) and notified bodies are currently building experience based on the first CDx consultation procedures that have been submitted from January 2022 onward. In the current article, we describe the new European regulatory framework for certification of CDx and highlight several challenges for medicine and CDx co-development. In addition, we briefly touch upon the interplay between the Clinical Trial Regulation (EU) No. 536/2014 (CTR) and the IVDR.
(© 2023 The Authors. Clinical Pharmacology & Therapeutics published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics.)
Databáze: MEDLINE
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