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  1. Learn About FDA Patient Engagement

Patient Engagement Cluster

The Food and Drug Administration (FDA) and the European Medicines Agency (EMA) established a workgroup in 2016 called the Patient Engagement Cluster to advance and strengthen international collaboration on patient engagement. Health Canada became official members in 2022.

The Patient Engagement Cluster joined a series of existing EMA/FDA clusters. The cluster allows FDA, EMA and Health Canada to share best practices involving patients along drug and biologic regulatory lifecycles. Information discussed by this group is covered by confidentiality agreements signed by the FDA, EMA and Health Canada.

The cluster focuses on specific topic areas where the FDA, EMA and Health Canada can benefit from a greater exchange of information and strengthen collaboration. These clusters discuss issues such as:

  • biosimilars

  • medicines to treat cancer

  • medicines for rare diseases

  • medicines for children

  • pharmacovigilance

The Patient Engagement Cluster meets virtually up to four times per year. This increased interaction helps each agency:

  • Learn how their respective patients are engaged and involved in the work performed.

  • Develop common goals of expanding future engagement activities with patients. 

The Patient Engagement Cluster workgroup discusses topics such as:

  • Ways for finding patients that appropriately speak for their community.

  • Ways to ensure patients involved in agency processes directly voice the concerns of their community.

  • Ways to train selected patients and advocates to effectively participate in agency activities.

  • Strategies for reporting the significant impact of patient involvement.

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