On December 6th, 2023, EMA released a Questions and Answers (Q&As) document that aims to provide an overview of the Agency’s current line of thinking on specific issues related to predictive biomarker-guided medicinal products development and assessment including a companion diagnostic (CDx) development. This Q&As document does not address assessment requirements for clinical trial approval by National Competent Authorities (NCA) or conformity assessment of candidate CDx by a notified body but provides guidance for generating adequate data for the marketing authorisation application for medicinal products.
New FAQ on medicinal product development and assessment involving a CDx
The Q&As aim to offer clarity on issues concerning predictive biomarker-guided medicinal product development and assessment, particularly in light of the implementation of the In Vitro Diagnostic Regulation (IVDR) 2017/746 and provides an overview of all current regulations, scientific and regulatory guidelines and procedural guidance documents that apply to CDx.
Below an excerpt of some of the questions addressed in the document:
This document provides detailed guidance for stakeholders involved in the development, assessment, and regulatory approval of medicinal products with companion diagnostics in the EU.