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EMA starts firming up its stance on personalised medicines

But draft guidelines won't be ready much before 2019


New draft European guidelines on personalised medicines and companion diagnostics are expected to be released by December 2018.

The European Medicines Agency (EMA) hopes that when finalised they will help optimise the co-development of medicines and companion diagnostics.

As more treatments like Pfizer’s Xalkori, Vertex’s Kalydeco and Boehringer Ingelheim’s Giotrif/Gilotrif come to market it also wants to better define those patients that will benefit from a personalised medicine

Ahead of that the European Medicines Agency (EMA) has put out for consultation a concept paper on the subject, with the move driven by new European medical device regulations.

The wide-ranging changes were set in motion by the 2008 scandal surrounding faulting PIP breast implants as well as safety concerns with metal-on-metal hip replacements.

The new rules, which already have broad industry support, are set to come into force in the next three to five years, when they will also impact developers of personalised medicines and the companion diagnostics they require.

As diagnostic medical devices, companion diagnostics do not fall within the oversight of the EMA, but the regulator is set for a greater role in the area.

The new In Vitro Diagnostics Regulation “foresees cooperation” between the medicines regulator and its medical device counterparts “in the evaluation of new companion diagnostics to obtain the CE label”.

The EMA’s concept paper notes that if a medicine’s labelling requires the use of a predictive biomarker then any commercial assay used for this will be considered a companion diagnostic, and therefore it too will need a CE mark.

The regulator says that its forthcoming guideline will set out “recommendations relating to the interface between predictive biomarker-based assays including companion diagnostics, and the development and lifecycle of medicine products”.

The EMA’s concept paper on predictive biomarker-based assay development in the context of drug development and lifecycle is open for consultation und 15 November, with a draft guideline anticipated nine to twelve months after that.

Article by
Dominic Tyer

23rd August 2017

From: Regulatory



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