Posted by Michael Wonder on 29 Jul 2017
Concept paper on development and lifecycle of personalised medicines and companion diagnostic
28 July 2017 - Public consultation to end on 31 October 2017.
The EMA has released for public consultation a concept paper on the development and lifecycle of personalised medicines and companion diagnostics that measure predictive biomarkers which help to assess the most likely response to a particular treatment. The concept paper is the first step in the preparation of a guideline that will address the development challenges of personalised medicines with companion diagnostics. Interested parties should submit comments to pgwpsecretariat@ema.europa.eu by 31 October 2017 using this template.
There is no common definition of personalised medicine, but in the context of this guidance the term refers to the targeted use of a treatment in a patient on the basis of the individual’s characteristics and genetic makeup and the understanding of how the treatment works.
