EMA Seeks Stakeholder Comments on Companion Diagnostics

August 11, 2017

The EMA released a concept paper that will form the basis of a new guideline on companion diagnostics.

The agency recently released its first guidance on IVD medical device regulation, but said more direction was needed on to the “interface” between drugs and predictive biomarker assays, including companion diagnostics.

One of the problems for the agency is that EU legislation covering marketing of drugs and IVDs is not linked. The new IVD regulation notes cooperation between notified bodies and drug regulators in evaluating a new companion diagnostic, but this does not lead to approval of a specific companion diagnostic.

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