European and US Medicines Agencies Coordinate on Patients Involvement

Submitted by GAtherton on 19 July 2016

The evaluation, supervision and safe monitoring of all of the medications that we take in Europe is the job of the European Medicines Agency (EMA). A similar function is carried out in the United States of America by the US Food & Drug  Administration (FDA).

The EMA and the FDA hold regular meetings by phone or videoconference, with the participation of other agencies globally,  in communication forums referred to as ‘clusters’. This system of cooperation has been ongoing for some years as the different agencies seek to share experiences and other information on subjects such as orphan drugs, veterinary medication and pediatric medication.

This summer sees the setting up of a cluster to coordinate on the involvement of patients in the lifecycle of medications (including development and evaluation of new drugs, and activities post-authorisation relating to medicines.

The aim of this cooperation is to identify areas that patient involvement may best benefit from the exchange of EMA & FDA experience. At this stage much work is to be carried out to optimise patient integration within the two agencies, how to be able to understand the contributions made by patients and to set up best practice policies but EMA Executive Director Guido Rasi expanded a little on the intended beneficial outcomes for patients when he said

“Our aim as regulators is to make sure that patients have access to safe and effective medicines that improve their lives. It is important to engage to be able to fully understand their needs and priorities and make their voice heard along a medicine’s lifecycle”