EMA, FDA Form New Collaboration Cluster for Patient Engagement

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 06-22-2016 16:16


The European Medicines Agency (EMA) and the US 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. The first meeting of the cluster took place by teleconference on June 22, 2016.

The clusters established by the 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 the EMA and the 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 the FDA and the 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.

Source: European Medicines Agency


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