Examining the regulatory differences between the European and US Pre-Approval Access Routes

Early Access to Medicines Programs (EAMs) in Europe provide pre-launch, pre-Market Authorisation, Unlicensed Medicines, pre-commercialisation, and Named Patient Programs access to drugs and treatments for patients with life-threatening conditions and no approved treatment options. EAM programs can be both product and country specific, are based on what you can negotiate, should not be cookie cutter, and are able to provide valuable information and in some cases limited financial returns. Increasingly, EAMs provide opportunities for early stakeholder engagement, RWE, clinical adoption support and in some cases, could foster swift patient access to breakthrough medical products