Regulatory Pathways
229 pathwaysCzech 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
DDA Nepal Special Import Authorization
Nepal Department of Drug Administration special import authorization for unregistered medicines needed for patients with serious or rare conditions.
Form: DDA Special Import Form
15–45d medium30dDrug Act 2035 (Nepal)
Denmark 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 Denmark.
Form: National compassionate use form
15–45d medium30dRegulated under EU Directive 2001/83/EC
DGDA Import Permit for Unregistered Drugs – Bangladesh
Directorate General of Drug Administration Bangladesh import permit for unregistered medicines needed by patients with serious medical conditions.
Form: DGDA Import Permit Form
15–45d medium45dDrugs Act 1940 (Bangladesh)
DIGEMID Special Authorization for Importation – Peru
Peru's DIGEMID special authorization for importation of unregistered medicines for individual patients with serious or life-threatening conditions.
Form: DIGEMID Special Import Form
15–45d medium30dGeneral Health Law No. 26842
Djibouti MOH Special Import Authorization
Djibouti Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: MOH Djibouti Special Import Form
>45d slow60dRegulated
Dominica MOH Special Import Authorization
Dominica Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: MOH Dominica Special Import Form
15–45d medium45dRegulated
Dominican Republic MOH Special Import Authorization
Dominican Republic Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: MOH Dominican Republic Special Import Form
15–45d medium30dRegulated
DQMDM Special Import Authorization – Kazakhstan
Kazakhstan Department for Quality of Medicinal Drugs and Medical Devices special import authorization for unregistered medicines for patients with serious conditions.
Form: DQMDM Special Import Form
15–45d medium30dKazakhstan Law on Medications
DRAP Special Import Authorization – Pakistan
Drug Regulatory Authority of Pakistan special import authorization allowing import of unregistered medicines for named patients with serious conditions.
Form: DRAP SIA Form
15–45d medium30dDRAP Act 2012
Early Access to Medicines Scheme (EAMS) – UK
EAMS provides patients with life-threatening or seriously debilitating conditions access to promising medicines before full marketing authorization. The scheme includes a scientific opinion from MHRA on the benefit-risk balance based on early clinical data.
Form: MHRA EAMS Application with Promising Innovative Medicine (PIM) designation
>45d slow90dStatutory
Ecuador MOH Special Import Authorization
Ecuador Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: MOH Ecuador Special Import Form
15–45d medium30dRegulated
EDA Compassionate Use Authorization – Egypt
Egyptian Drug Authority compassionate use authorization allowing access to unregistered medicines for patients with serious or life-threatening conditions.
Form: EDA CU Form
15–45d medium30dPharmacy Practice Law No. 127/1955
EFDA Special Import Authorization – Ethiopia
Ethiopian Food and Drug Authority special import authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: EFDA Special Import Form
15–45d medium30dEthiopian Food, Drug and Health Administration Proclamation
El Salvador MOH Named Patient Authorization
El Salvador Ministry of Health named patient authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: MOH El Salvador Named Patient Form
15–45d medium30dRegulated
EMA Orphan Drug Designation
EU designation for medicines treating life-threatening or chronically debilitating rare conditions (prevalence <=5 in 10,000), granting up to 10 years market exclusivity.
Statutory
EMA PRIME (Priority Medicines) Scheme
EU scheme offering enhanced scientific and regulatory support to promising medicines addressing unmet medical needs, enabling accelerated assessment.
Administrative
Equatorial Guinea MOH Special Import Authorization
Equatorial Guinea Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: MOH Equatorial Guinea Special Import Form
15–45d medium45dRegulated
Eritrea MOH Special Import Authorization
Eritrea Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: MOH Eritrea Special Import Form
>45d slow60dRegulated
Estonia 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 Estonia.
Form: National compassionate use form
15–45d medium30dRegulated under EU Directive 2001/83/EC
Eswatini MOH Special Import Authorization
Eswatini Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: MOH Eswatini Special Import Form
15–45d medium45dRegulated
Expanded Access Program – USA
FDA pathway allowing patients with serious diseases access to investigational drugs outside clinical trials. Requires manufacturer agreement and FDA approval.
Form: Form FDA 3926
15–45d medium30dStatutory
FDA Accelerated Approval
US pathway allowing approval of drugs for serious conditions based on a surrogate endpoint reasonably likely to predict clinical benefit, with required confirmatory trials.
Statutory
FDA Breakthrough Therapy Designation
US designation to expedite development and review of drugs showing substantial improvement over available therapy on a clinically significant endpoint.
Statutory