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Europe: EMA finalizes companion diagnostic guidance

2022/07/11  EMA

This guidance document is intended to provide the relevant parties, in particular notified bodies, device manufacturers and medicinal product applicants, with information about procedural aspects of the consultation procedure to the EMA by a notified body on a companion diagnostic (CDx). As per the Regulation (EU) 2017/746, a CDx is essential for defining patients’ eligibility for specific treatment with a medicinal product through the quantitative or qualitative determination of specific markers (i.e., biomarkers1) 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(s) can be present in healthy subjects and/or in patients.

As part of the conformity assessment of a CDx, the notified body shall seek a scientific opinion on the suitability of the CDx with the concerned medicinal product(s), from either one of the competent authorities of medicinal products designated by the Member States in accordance with Directive 2001/83/EC or from the EMA before issuing an EU technical documentation assessment certificate or an EU type-examination certificate, or a supplement to them for the CDx.

  • In the case that the corresponding medicinal product (or one of them if multiple) falls within the mandatory scope of the centralised procedure (Annex I to Regulation (EC) No 726/2004), it is mandatory for the notified body to consult the EMA.
  • If the corresponding medicinal product is already authorised, or if an application for its authorisation has been submitted, the notified body shall consult the medicinal product authority that is responsible for the authorisation. Therefore, for a medicinal product submitted and/or authorised through the centralised procedure under the optional scope, the notified body should consult the EMA.

The applicant for the consultation should be a notified body duly designated to carry out conformity assessments according to the provisions of Regulation (EU) 2017/746.

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