Access Programs

214 programs
Eritrea Named Patient Program
Patient with serious or life-threatening condition, no registered alternative available
Named Patient Program60d
Eswatini Named Patient Program
Patient with serious or life-threatening condition, no registered alternative available
Named Patient Program45d
Ethiopia Named Patient Program
Framework: Ethiopian Drug Proclamation
Patient with serious or life-threatening condition, no registered alternative available
Named Patient Program30d
FDA Expanded Access Program
Framework: 21 CFR 312.310-320
Patient with serious or life-threatening condition, no registered alternative available
Expanded Access30d
FDA Expanded Access Program (EAP)
Framework: 21 CFR 312.320
Patient has serious or life-threatening condition; no comparable/satisfactory alternative therapy; potential patient benefit justifies potential risks; patient enrollment in clinical trial not feasible; expanded access will not interfere with investigational trials
Expanded Access30d
Fiji Named Patient Program
Framework: Pharmacy and Poisons Act Fiji
Patient with serious or life-threatening condition, no registered alternative available
Named Patient Program21d
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
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
Gabon Named Patient Program
Patient with serious or life-threatening condition, no registered alternative available
Named Patient Program45d
Gambia Named Patient Program
Patient with serious or life-threatening condition, no registered alternative available
Named Patient Program45d
Georgia Named Patient Program
Patient with serious or life-threatening condition, no registered alternative available
Named Patient Program30d
Germany Compassionate Use Program (§21a AMG)
Framework: §21a AMG
Patient with serious or life-threatening condition, no registered alternative available
Compassionate Use30d
Ghana Named Patient Program
Framework: Public Health Act 2012
Patient with serious or life-threatening condition, no registered alternative available
Named Patient Program21d
Grenada Named Patient Program
Patient with serious or life-threatening condition, no registered alternative available
Named Patient Program45d
Guatemala Named Patient Program
Patient with serious or life-threatening condition, no registered alternative available
Named Patient Program30d
Guinea Named Patient Program
Patient with serious or life-threatening condition, no registered alternative available
Named Patient Program45d
Guinea-Bissau Named Patient Program
Patient with serious or life-threatening condition, no registered alternative available
Named Patient Program45d
Guyana Named Patient Program
Patient with serious or life-threatening condition, no registered alternative available
Named Patient Program45d
Haiti Named Patient Program
Patient with serious or life-threatening condition, no registered alternative available
Named Patient Program45d
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
Honduras Named Patient Program
Patient with serious or life-threatening condition, no registered alternative available
Named Patient Program45d
India Compassionate Use Program (Rule 96)
Framework: NDCT Rules 2019 Rule 96
Patient with serious or life-threatening condition, no registered alternative available
Compassionate Use21d
India Named Patient Program (Form 12B)
Framework: NDCT Rules 2019 Rule 101
Patient with serious or life-threatening condition, no registered alternative available
Named Patient Program30d
Indonesia Special Access Scheme
Framework: Government Regulation No. 72/1998
Patient with serious or life-threatening condition, no registered alternative available
Special Access30d
Iran Named Patient Program
Framework: Iran Food and Drug Regulations
Patient with serious or life-threatening condition, no registered alternative available
Named Patient Program45d
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