Regulatory Pathways
218 pathwaysBPOM Special Access Scheme (SAS) – Indonesia
Indonesia's BPOM Special Access Scheme allowing import and use of unregistered medicines for patients with serious or life-threatening conditions on a named patient basis.
Form: BPOM SAS Form
15–45d medium30dGovernment Regulation No. 72/1998
Brunei MOH Special Import Authorization
Brunei Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: MOH Brunei Special Import Form
15–45d medium45dRegulated
Bulgaria Compassionate Use (Article 83 EMA)
EMA Article 83 compassionate use framework allowing access to unauthorised medicinal products for groups of patients with a chronically or seriously debilitating or life-threatening disease in Bulgaria.
Form: National compassionate use form
15–45d medium30dRegulated under EU Directive 2001/83/EC
Burkina Faso MOH Special Import Authorization
Burkina Faso Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: MOH Burkina Faso Special Import Form
15–45d medium45dRegulated
Burundi MOH Special Import Authorization
Burundi Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: MOH Burundi Special Import Form
>45d slow60dRegulated
Cabo Verde MOH Special Import Authorization
Cabo Verde Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: MOH Cabo Verde Special Import Form
15–45d medium45dRegulated
Cambodia MOH Special Import Authorization
Cambodia Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: MOH Cambodia Special Import Form
15–45d medium45dRegulated
Cameroon MOH Autorisation Exceptionnelle
Cameroon Ministry of Health exceptional authorization for import of unregistered medicines for patients with serious or life-threatening conditions.
Form: MOH Cameroon Exceptional Authorization Form
15–45d medium30dRegulated
CDSCO Compassionate Use (Rule 96) – India
Rule 96 of NDCT Rules 2019 allows compassionate use of new drugs for patients with serious or life-threatening diseases who are not eligible for clinical trials and have no other treatment options.
Form: CDSCO CU Application
15–45d medium21dNDCT Rules 2019 Rule 96
Central African Republic MOH Special Import Authorization
Central African Republic Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: MOH Central African Republic Special Import Form
>45d slow60dRegulated
Chad MOH Special Import Authorization
Chad Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: MOH Chad Special Import Form
>45d slow60dRegulated
COFEPRIS Compassionate Use Authorization – Mexico
COFEPRIS compassionate use authorization allowing access to unregistered medicines for patients with serious or life-threatening conditions in Mexico.
Form: COFEPRIS CU Form
15–45d medium30dGeneral Health Law Article 167
Comoros MOH Special Import Authorization
Comoros Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: MOH Comoros Special Import Form
>45d slow60dRegulated
Compassionate Use Program – Singapore (HSA)
The Health Sciences Authority allows import and use of unregistered therapeutic products for named patients with serious diseases under the Compassionate Use Programme. Applications must demonstrate that standard treatments have failed or are unsuitable.
Form: HSA Compassionate Use Application with supporting clinical documentation
<15d fast14dAdministrative
Compassionate Use Programme – Brazil (ANVISA)
Brazil's Programa de Acesso Expandido allows access to investigational drugs not yet registered with ANVISA for patients with serious or life-threatening conditions. The programme requires submission through the prescribing physician and institutional ethics committee approval.
Form: ANVISA Form 25351-1 (Expanded Access Request)
15–45d medium45dStatutory
Compassionate Use Programme – South Africa
SAHPRA mechanism for accessing unregistered medicines for patients with serious or life-threatening conditions. Requires detailed motivation from treating physician.
Form: Section 21 Application Form
15–45d medium21dRegulatory
Congo (Democratic Republic) MOH Special Import Authorization
Congo (Democratic Republic) Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: MOH Congo (Democratic Republic) Special Import Form
>45d slow60dRegulated
Congo MOH Special Import Authorization
Congo Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: MOH Congo Special Import Form
>45d slow60dRegulated
Costa Rica MOH Named Patient Authorization
Costa Rica Ministry of Health named patient authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: MOH Costa Rica Named Patient Form
15–45d medium30dRegulated
Côte d'Ivoire MOH Autorisation Exceptionnelle
Côte d'Ivoire Ministry of Health exceptional authorization for import of unregistered medicines for patients with serious or life-threatening conditions.
Form: MOH Côte d'Ivoire Exceptional Authorization Form
15–45d medium30dRegulated
Croatia Compassionate Use (Article 83 EMA)
EMA Article 83 compassionate use framework allowing access to unauthorised medicinal products for groups of patients with a chronically or seriously debilitating or life-threatening disease in Croatia.
Form: National compassionate use form
15–45d medium30dRegulated under EU Directive 2001/83/EC
Cuba MOH Special Import Authorization
Cuba Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: MOH Cuba Special Import Form
15–45d medium45dRegulated
Cyprus Compassionate Use (Article 83 EMA)
EMA Article 83 compassionate use framework allowing access to unauthorised medicinal products for groups of patients with a chronically or seriously debilitating or life-threatening disease in Cyprus.
Form: National compassionate use form
15–45d medium30dRegulated under EU Directive 2001/83/EC
Czech Republic Compassionate Use (Article 83 EMA)
EMA Article 83 compassionate use framework allowing access to unauthorised medicinal products for groups of patients with a chronically or seriously debilitating or life-threatening disease in Czech Republic.
Form: National compassionate use form
15–45d medium30dRegulated under EU Directive 2001/83/EC
DAV Special Import Authorization – Vietnam
Vietnam Drug Administration special import authorization allowing access to unregistered medicines for patients with serious medical needs under physician supervision.
Form: MOH Vietnam Special Import Form
15–45d medium30dPharmaceutical Law 2016