Regulatory Pathways
229 pathwaysIceland 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 Iceland.
Form: National compassionate use form
15–45d medium30dRegulated under EU Directive 2001/83/EC
India Named Patient Import (Form 12B)
Under India's New Drugs and Clinical Trials Rules 2019, a named patient can import unapproved drugs...
Form: Form 12B
15–45d medium30dRegulated
INVIMA Special Import for Unregistered Drugs – Colombia
INVIMA special import authorization allowing physicians to import unregistered medicines for named patients with serious conditions in Colombia.
Form: INVIMA Special Import Form
15–45d medium21dDecreto 677 de 1995
Iran MOH Special Import Authorization
Iran Food and Drug Administration special import authorization for access to medicines not registered in Iran for patients with serious or life-threatening conditions.
Form: IFDA Special Import Form
15–45d medium45dIran Food and Drug Act
Iraqi MOH Exceptional Import Authorization
Iraq Ministry of Health exceptional import program allowing access to unregistered medicines for patients with serious conditions not treatable with locally available products.
Form: MOH Iraq Import Permission
15–45d medium45dIraqi Drug Regulation
Ireland 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 Ireland.
Form: National compassionate use form
15–45d medium30dRegulated under EU Directive 2001/83/EC
ISP Provisional Authorization for Unregistered Products – Chile
Chile's ISP provisional authorization allowing import and use of unregistered medicinal products for patients with serious medical needs.
Form: ISP Provisional Authorization Form
15–45d medium30dHealth Code Article 100
Israeli MOH Compassionate Use (Section 27) – Israel
Israel allows compassionate use of unapproved drugs under Section 27 of the Pharmacists Ordinance for patients with serious or life-threatening conditions who have exhausted approved treatment options.
Form: MOH Israel CU Application
15–45d medium30dPharmacists Ordinance Section 27
Italy 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 Italy.
Form: National compassionate use form
15–45d medium30dRegulated under EU Directive 2001/83/EC
Jamaica MOH Special Import Authorization
Jamaica Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: MOH Jamaica Special Import Form
15–45d medium30dRegulated
Japan Compassionate Use (Dojo) – PMDA
PMDA's compassionate use (Dojo) system allows access to promising investigational drugs for patients who have exhausted other treatments and cannot wait for full approval.
Form: PMDA CU Application
>45d slow60dPharmaceutical and Medical Device Act (PMD Act)
Japan Early Conditional Approval System
Japan's early conditional approval system allowing accelerated approval of certain drugs with post-marketing commitments for patients with serious unmet medical needs.
Form: PMDA Early Conditional Approval Application
>45d slow180dPMD Act – Early Approval System
JFDA Compassionate Use – Jordan
Jordan Food and Drug Administration compassionate use program allowing access to unregistered medicines for patients with serious or life-threatening diseases.
Form: JFDA CU Form
15–45d medium21dJordanian Drug and Food Law No. 80 of 2001
Jian Zhen Yao Wu – China
NMPA program for importing small quantities of unlicensed foreign drugs for urgent clinical needs. Limited to specific hospitals and medical institutions.
Form: Import License Application
15–45d medium45dAdministrative
KFDA Special Import Program – Kuwait
Kuwait Food and Drug Authority special import program allowing import of unregistered medicinal products for named patients with unmet medical needs.
Form: MOH Kuwait Drug Import Form
15–45d medium30dKuwait Drug Regulation
Kiribati MOH Special Import Authorization
Kiribati Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: MOH Kiribati Special Import Form
>45d slow60dRegulated
Kyrgyzstan MOH Special Import Authorization
Kyrgyzstan Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: MOH Kyrgyzstan Special Import Form
15–45d medium45dRegulated
Laos MOH Special Import Authorization
Laos Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: MOH Laos Special Import Form
>45d slow60dRegulated
Latvia 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 Latvia.
Form: National compassionate use form
15–45d medium30dRegulated under EU Directive 2001/83/EC
Legge 648/96 – Italy Off-Label Reimbursement
Italian Law 648/96 allows off-label reimbursement of medicines not yet authorised in Italy for rare diseases or conditions where no valid alternative exists.
Form: AIFA Legge 648 Application
15–45d medium45dLegge 648/96
Lesotho MOH Special Import Authorization
Lesotho Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: MOH Lesotho Special Import Form
15–45d medium45dRegulated
Liberia MOH Special Import Authorization
Liberia Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: MOH Liberia Special Import Form
15–45d medium45dRegulated
Libya MOH Special Import Authorization
Libya Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: MOH Libya Special Import Form
15–45d medium45dRegulated
Licensläkemedel (Licensed Medicine) – Sweden
Swedish licensed medicine system allowing Läkemedelsverket to grant licenses for unlicensed medicines for individual patients when no suitable licensed alternative exists.
Form: Läkemedelsverket License Application
<15d fast14dLäkemedelslagen (Swedish Medicinal Products Act)
Liechtenstein 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 Liechtenstein.
Form: National compassionate use form
15–45d medium30dRegulated under EU Directive 2001/83/EC