What is an early access program (EAP)?
An EAP, also known as compassionate use or expanded access, is a mechanism that provides eligible patients with access to investigational medicines outside of clinical trials. These programs are typically used when no satisfactory alternatives exist and are governed by strict regulatory requirements.
Why are EAPs important in pharmaceutical development?
EAPs offer patients potential benefit while allowing companies to collect additional safety or real-world data. They also build goodwill with the clinical and patient community, support pre-launch engagement, and may inform future regulatory and access strategies. Managing EAPs effectively requires close coordination with Regulatory and Medical Affairs teams.
