Taking into consideration the recent implementation of the Regulation 2017/746 (In vitro diagnostic regulation (IVDR)), this Questions and Answers (Q&As) document 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. It is proposed to address issues that may require further clarity, considering their recurrence in preauthorisation interactions and in the context of marketing authorisation/variation applications of medicinal products (hereafter referred to as drug regulatory submissions).
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.
These Q&As should be read in conjunction with the relevant regulations, scientific and regulatory guidelines and procedural guidance documents. In particular, the following Regulation is of relevance for CDx development and assessment as in vitro diagnostic medical device:
Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices (IVDR) (1)
Within the current regulatory framework, ‘companion diagnostic’ is defined in the Art. 2 (7) of the IVDR, as a device which is essential for the safe and effective use of a corresponding medicinal product to:
Further, according to the IVDR, “…tests that provide information to predict treatment response or reactions, such as companion diagnostics, are in vitro diagnostic medical devices.
Companion diagnostics are essential for defining patients’ eligibility for specific treatment with a medicinal product through the quantitative or qualitative determination of specific markers identifying subjects at a higher risk of developing an adverse reaction to the medicinal product in question or identifying patients in the population for whom the therapeutic product has been adequately studied, and found safe and effective. Such biomarker or biomarkers can be present in healthy subjects and/or in patients. Devices that are used with a view to monitoring treatment with a medicinal product in order to ensure that the concentration of relevant substances in the human body is within the therapeutic window are not considered to be companion diagnostics.”
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