Regulatory Pathways
218 pathwaysItaly 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
Lithuania 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 Lithuania.
Form: National compassionate use form
15–45d medium30dRegulated under EU Directive 2001/83/EC
Luxembourg 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 Luxembourg.
Form: National compassionate use form
15–45d medium30dRegulated under EU Directive 2001/83/EC
Madagascar MOH Special Import Authorization
Madagascar Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: MOH Madagascar Special Import Form
15–45d medium45dRegulated
Malawi MOH Special Import Authorization
Malawi Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: MOH Malawi Special Import Form
15–45d medium45dRegulated
Maldives MOH Special Import Authorization
Maldives Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: MOH Maldives Special Import Form
15–45d medium45dRegulated
Mali MOH Special Import Authorization
Mali Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: MOH Mali Special Import Form
15–45d medium45dRegulated
Malta 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 Malta.
Form: National compassionate use form
15–45d medium30dRegulated under EU Directive 2001/83/EC
MAPHAR Autorisation Exceptionnelle d'Importation – Morocco
Morocco's Direction du Médicament (MAPHAR) exceptional import authorization for unregistered medicines for patients with serious medical needs.
Form: MAPHAR Exceptional Import Form
15–45d medium30dDahir No. 1-06-151 (Moroccan Drug Law)