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Engaging patients in medicines regulation: a tale of two agencies
The European Medicines Agency and the US Food and Drug Administration have committed to engaging patients in their regulatory processes to promote patient-focused medicinal product development, as well as improve transparency and trust in the regulatory system. Here, we highlight exchanges of experience between the agencies and some impacts on patient engagement.
The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) both consider that the voices of patients in medicines regulation are essential, as they bring the unique perspective of someone living with a disease, as a patient or carer. This perspective complements the medical and scientific information that is used when evaluating medicines for regulatory approval. For example, patients can highlight unmet needs for their condition that they consider to be particularly important, which might differ from the standard end points evaluated in clinical trials.