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Overcoming the Challenges of Establishing Expanded Access Programs in European Member States
Published on: May 8, 2017
Early access programs (EAP) provide unauthorized medicinal products prior to marketing authorization and commercial launch for life-threatening, chronically or seriously debilitating diseases, which can not be treated satisfactorily by an authorized medicinal product. Legislation is mostly at the national level, and practical aspects such as conduct, sponsorship, permission to charge for the medicinal product, and data collection frequently differ per country. Organizers must also consider differing national medical practices and standards of care.
This poster aims to review current status and challenges associated with mechanisms governing the provision of unlicensed pharmaceutical compounds in areas of high unmet need outside of clinical trials and provides recommendations for avoiding common pitfalls based on review of actual case studies in selected markets.
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