In November 2023, European Medicines Agency (EMA) issued a document on the Committee for Medicinal Products for Human Use (CHMP) early contact with patient and healthcare professional organisations, including the related process and frequently questions and answers concerning different aspects of this methodology.

Patients and healthcare professionals are involved in a wide range of EMA activities, either as representatives of their organisations or as individual experts including in the evaluation of specific medicines.

The aim of early consultation is to gain insight on aspects of a condition and its currently available treatments (if any) that regulators may not be aware of, so that they may consider those aspects at the beginning of the assessment process. Patients and healthcare professionals can provide important contributions on, for example, the impact of the condition on patients, most important symptoms, how patients are treated, unmet needs, expectations for future treatments, and outcomes or trial endpoints that they would find important for a medicine to demonstrate clinical benefit. The early consultation does not aim to collect positions on the medicinal product under assessment from the consulted organisations.

The process for consultation foresees that EMA extracts a list of submissions for the month in question, consults with the core group at the CHMP, and follows up on the selected products with the eligible patient and healthcare professional organisations for their input. The eligible organisations have 4-5 weeks from receiving the request to return their comments using a template.

Discover more by consulting the full document here.

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