The European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) have set up a new ‘cluster’ on patient engagement to share experiences and best practices on the way they involve patients and patient organisations in the development, evaluation and post-authorisation activities related to medicines.
This increased interaction through the new cluster will allow the EMA and FDA to exchange information on how they engage with and involve patients in their work and on priorities and goals to scale up future engagement with patients. Because patients bring real-life experience to scientific discussions, the agencies are making their involvement a priority.
Areas of discussion will include: the processes for selecting and preparing patients to take part in the agencies’ activities, how to ensure that patients are independent and representative and how to report on the impact of patient involvement.
“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,” explains Guido Rasi, EMA Executive Director.
“Many of the challenges and benefits of working with patients are similar for both regulators. We look forward to increasing our collaboration with FDA in this area in order to benefit from each other’s experiences, and to advance patient involvement.”
The first meeting of the cluster took place by teleconference on 22 June 2016.
The new cluster is expected to meet three to four times per year via teleconference and will be chaired jointly by FDA and EMA.
The creation of this cluster is the latest step in EMA’s and FDA’s wider approach to expand and reinforce international collaboration.
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