Access Programs
27 programsAlbania Compassionate Use Program
Patient with serious or life-threatening condition, no registered alternative available
Compassionate Use30d
Argentina Compassionate Use Program
Framework: Law 16.463
Patient with serious or life-threatening condition, no registered alternative available
Compassionate Use30d
Bahrain Compassionate Use Program
Framework: NHRA Regulatory Framework
Patient with serious or life-threatening condition, no registered alternative available
Compassionate Use14d
Bosnia and Herzegovina Compassionate Use Program
Framework: BiH Law on Medicines and Medical Devices
Patient with serious or life-threatening condition, no registered alternative available
Compassionate Use30d
Botswana Compassionate Use Program
Framework: Drugs and Related Substances Act
Patient with serious or life-threatening condition, no registered alternative available
Compassionate Use21d
China Compassionate Use Program
Framework: Drug Administration Law 2019
Patient with serious or life-threatening condition, no registered alternative available
Compassionate Use60d
Compassionate Use Program
Framework: EMA Article 83, FDA Expanded Access
Serious or life-threatening condition, no alternative treatment, benefit-risk assessment.
Compassionate Use30d
Egypt Compassionate Use Program
Framework: Pharmacy Practice Law No. 127/1955
Patient with serious or life-threatening condition, no registered alternative available
Compassionate Use30d
EMA Compassionate Use Programme
Framework: EU Regulation 726/2004 Article 83
Patient group with chronically or seriously debilitating disease or life-threatening condition; no authorized treatment available; patient cannot enter clinical trial; medicinal product subject to marketing authorization application or clinical trials
Compassionate Use60d
Germany Compassionate Use Program (§21a AMG)
Framework: §21a AMG
Patient with serious or life-threatening condition, no registered alternative available
Compassionate Use30d
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
Israel Compassionate Use Program
Framework: Pharmacists Ordinance Section 27
Patient with serious or life-threatening condition, no registered alternative available
Compassionate Use30d
Italy Compassionate Use Program
Framework: Decreto Ministeriale 7 settembre 2017
Patient with serious or life-threatening condition, no registered alternative available
Compassionate Use45d
Japan Compassionate Use Program
Framework: Pharmaceutical and Medical Device Act
Patient with serious or life-threatening condition, no registered alternative available
Compassionate Use60d
Japan Compassionate Use System
Framework: Pharmaceutical Affairs Law Article 80
Serious life-threatening disease with no approved treatment in Japan; drug under development or approved overseas; clinical trial participation not possible; physician determines medical necessity; institutional review board approval
Compassionate Use45d
Jordan Compassionate Use Program
Framework: Jordanian Drug and Food Law No. 80 of 2001
Patient with serious or life-threatening condition, no registered alternative available
Compassionate Use21d
Mexico Compassionate Use Program
Framework: General Health Law Article 167
Patient with serious or life-threatening condition, no registered alternative available
Compassionate Use30d
Montenegro Compassionate Use Program
Patient with serious or life-threatening condition, no registered alternative available
Compassionate Use30d
North Macedonia Compassionate Use Program
Patient with serious or life-threatening condition, no registered alternative available
Compassionate Use30d
Philippines Compassionate Special Permit
Framework: RA 9711 FDA Act 2009
Patient with serious or life-threatening condition, no registered alternative available
Compassionate Use21d
Qatar Compassionate Use Program
Framework: MOPH Qatar Drug Regulations
Patient with serious or life-threatening condition, no registered alternative available
Compassionate Use21d
Russia Unregistered Drug Access Program
Framework: Federal Law No. 61-FZ
Patient with serious or life-threatening condition, no registered alternative available
Compassionate Use30d
Serbia Compassionate Use Program
Framework: Law on Medicines and Medical Devices
Patient with serious or life-threatening condition, no registered alternative available
Compassionate Use30d
Spain Uso Compasivo Program
Framework: Real Decreto 1015/2009
Patient with serious or life-threatening condition, no registered alternative available
Compassionate Use30d
Switzerland Compassionate Use Program
Framework: Therapeutic Products Act (HMG)
Patient with serious or life-threatening condition, no registered alternative available
Compassionate Use30d
Page 1 of 2 (27 total)