Concept paper on development and lifecycle of personalised medicines and companion diagnostics

28 July 2017

Public consultation to end on 15 November 2017

The European Medicines Agency (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 [e-mail] by 15 November 2017 using .

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.

The choice of a personalised medicine relies on the use of a companion diagnostic, a diagnostic medical device which allows identifying patients who are most likely to benefit from a specific medicine. The device can also identify patients who are likely to be at increased risk of serious adverse reactions as a result of treatment with the associated medicine. It is very important to clarify how evidence to support the validation of a companion diagnostic can be generated during the development of a medicine.

While EMA does not issue recommendations on companion diagnostics, the recently revised European Union (EU) legislation on in vitro diagnostic medical devices¹foresees 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 label².

The future guideline will replace the existing Reflection paper on co-development of pharmacogenomic biomarkers and Assays in the context of drug development.

Notes

• ¹Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
• ²CE marking 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.