On 28 July, the European Medicines Agency (EMA) released a concept paper on personalised medicine for public consultation.
The recently published EMA paper talks about 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.
Whereas there is currently no common definition of personalised medicine, this guidance refers to it as 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.
While EMA does not issue recommendations on companion diagnostics, the recently revised European Union (EU) Regulation on in vitro diagnostic medical devices foresees cooperation between medicines regulators and EU notified bodies, which conduct the conformity assessment of medical devices in the EU, in the evaluation of new companion diagnostics to obtain the CE label, which is the medical device manufacturer's claim that a product meets the essential requirements of all relevant European Medical Device Directives and is a legal requirement to place a device on the EU market.
The concept paper is supposed to be the first step in the preparation of a guideline that will address the development challenges of personalised medicines with companion diagnostics and is meant to replace the existing reflection paper on co-development of pharmacogenomics markers and assays in the context of drug development.
The deadline to submit comments is 15 November 2017.
The concept paper can be found here.