Pharma Knowledge Layer · Global Orphan Drug Access Intelligence

Pharma Knowledge Base

Access Programs

2 programs

All Named Patient Compassionate Use Early Access Expanded Access Special Access

Early Access Program

Framework: MHRA EAMS, ANSM ATU

Pre-approval drug with strong efficacy data in clinical trials.

Early Access90d

France ATU/AAP Early Access Program

Framework: Article L.5121-12 Code de la Santé Publique

Patient with serious or life-threatening condition, no registered alternative available

Early Access60d