Pharma Knowledge Layer · Global Orphan Drug Access Intelligence

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Access Programs

4 programs

All Named Patient Compassionate Use Early Access Expanded Access Special Access

Australian Special Access Scheme (SAS)

Framework: Therapeutic Goods Act 1989 Section 19

Patient requires therapeutic good not included in Australian Register; serious condition where no registered alternative exists; practitioner believes access necessary; Category A (life-threatening) or Category B (serious condition) pathways available

Named Patient2d

Australian Special Access Scheme (SAS) Category B

Framework: Therapeutic Goods Act 1989

Seriously ill patients with no other treatment options, requires physician notification to TGA

Named Patient2d

French ATU Nominative

Framework: Article L.5121-12 French Public Health Code

Life-threatening or rare disease, no suitable alternative treatment available in France

Named Patient7d

Health Canada Special Access Programme (SAP)

Framework: Food and Drug Regulations C.08.010

Serious or life-threatening condition; conventional therapies failed, unsuitable, or unavailable; evidence of potential benefit outweighs risk; patient cannot access through clinical trial; practitioner authorization required

Named Patient15d