EMA Framework for stakeholder’s engagement – patients, academia, healthcare professionals

Published by IRDiRC

Research and Drug DevelopmentRegulatory AffairsEarly Access SupportScientific AdviceStakeholder EngagementHealthcare Professional

The Agency has been interacting with its stakeholders since its inception. These stakeholder relations have evolved over time and the type and degree of interaction is varied depending on the stakeholder groups and fields of Agency activity.

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The European Network of Paediatric Research at the European Medicines Agency (Enpr- EMA) is a network of research networks, investigators and centres with recognised expertise in performing clinical studies in children. Enpr-EMA enables networking and collaboration with members from within and outside the European Union (EU), including academia and the pharmaceutical industry

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At the FDA, the Patient Affairs Staff (PAS) is devoted to supporting cross-cutting patient engagement activities across the FDA. Its mission is to coordinate and support patient engagement activities across FDA to facilitate awareness and collaboration with patients, their advocates and the FDA

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In Japan, drugs, medical devices, and regenerative medical products can be designated as orphan drugs, medical devices, or regenerative medical products based on the Article 77-2 of the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics if they are intended for use in basically less than 50 000 patients in Japan and for which there is a high medical need.

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This FDA program allows early access to drugs and medical devices before marketing approval, under regulatory oversight with collection of Safety data, to individual patients with serious or immediately life-threatening diseases or conditions who lack therapeutic alternatives. This includes emergency and non-emergency expanded access.

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Compassionate use is a treatment option that allows the use of an unauthorised medicine. Under strict conditions, products in development can be made available to groups of patients who have a disease with no satisfactory authorised therapies and who cannot enter clinical trials.

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