EMA and FDA reinforce collaboration on patient engagement

News 22/06/2016

New working group established to exchange best practices

The European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) have set up a new 'cluster' on patient engagement. The cluster will provide a forum to share experiences and best practices on the way the two agencies involve patients in development, evaluation and post-authorisation activities related to medicines.

Patients bring real-life experience, as well as specific knowledge and expertise, to scientific discussions on medicines and on the impact of regulatory decisions. Therefore, their involvement is a priority for both agencies.

“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 clusters established by EMA and regulators outside the European Union focus on specific topic areas where the parties involved could benefit from an intensified exchange of information and strengthened collaboration. The currently existing EMA/FDA clusters discuss issues related to biosimilars, medicines to treat cancer, orphan medicines, medicines for children, and pharmacovigilance, among other topics.

The increased interaction through the new cluster will allow 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. 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.

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.

The information exchange is covered by the confidentiality arrangements between the two regulators.

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