Bringing a new treatment to market requires marketing authorisation (MA) and successful pricing and reimbursement negotiations. Early access programmes (EAPs) and schemes allows access to medicines for rare or severe diseases. These programmes can have a significantly positive impact for patients, where patients can access orphan drugs which they may not be able to otherwise.
This guidance note focusses on early access schemes in Europe, discussing how to use these regulatory opportunities, the types of schemes available, stakeholder engagement opportunities, and the likelihood of achieving an early access recommendation.

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