Navigating medicinal products development and assessment involving companion diagnostics: A guide to addressing key questions under Regulation 2017/746 (IVDR) 

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This Q&As document outlines the European Medicines Agency’s (EMA) perspective on critical issues related to the development and assessment of medicinal products, especially those involving companion diagnostics (CDx), following the implementation of Regulation 2017/746 (IVDR).
It aims to offer insights and clarification on recurrent issues encountered during pre-authorization interactions and marketing authorization/variation applications for medicinal products.