Regulatory Pathways
218 pathwaysNiger MOH Special Import Authorization
Niger Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: MOH Niger Special Import Form
15–45d medium45dRegulated
NMPA Compassionate Use – China
China's NMPA allows conditional approval and compassionate use of drugs under the 2019 Drug Administration Law for patients with serious or life-threatening conditions who have no other options.
Form: NMPA CU Application
>45d slow60dDrug Administration Law 2019 Article 23
NMRA Special Import Authorization – Sri Lanka
Sri Lanka National Medicines Regulatory Authority special import authorization for unregistered medicines for patients with serious medical needs.
Form: NMRA SIA Form
15–45d medium21dNational Medicines Regulatory Authority Act
NMRC Special Import Authorization – Namibia
Namibia Medicines Regulatory Council special import authorization for unregistered medicines for patients with serious medical needs.
Form: NMRC Special Import Form
15–45d medium30dMedicines and Related Substances Control Act
North Korea MOH Special Import Authorization
North Korea Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: MOH North Korea Special Import Form
15–45d medium45dRegulated
North Macedonia Compassionate Use Authorization
North Macedonia regulatory authority compassionate use authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: North Macedonia CU Application Form
15–45d medium30dRegulated
Norway 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 Norway.
Form: National compassionate use form
15–45d medium30dRegulated under EU Directive 2001/83/EC
NPRA Special Access Scheme – Malaysia
Malaysia's National Pharmaceutical Regulatory Agency Special Access Scheme allowing access to unregistered medicines for patients with serious or life-threatening conditions.
Form: NPRA SAS Form
<15d fast14dControl of Drugs and Cosmetics Regulations 1984
Oman MOH Special Import Program
Oman Ministry of Health special import permit allowing access to unregistered medicines for patients with serious or life-threatening conditions requiring treatment not available locally.
Form: MOH Oman Import Permit
15–45d medium30dOman Drug Regulation
Palau MOH Special Import Authorization
Palau Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: MOH Palau Special Import Form
>45d slow60dRegulated
Panama MOH Named Patient Authorization
Panama Ministry of Health named patient authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: MOH Panama Named Patient Form
15–45d medium30dRegulated
Paraguay MOH Special Import Authorization
Paraguay Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: MOH Paraguay Special Import Form
15–45d medium30dRegulated
Pharmacy Board Special Import Permit – Mauritius
Mauritius Pharmacy Board special import permit for unregistered medicines for patients with serious medical conditions.
Form: Pharmacy Board Mauritius Special Import Form
<15d fast14dPharmacy Act (Mauritius)
Poland 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 Poland.
Form: National compassionate use form
15–45d medium30dRegulated under EU Directive 2001/83/EC
Portugal 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 Portugal.
Form: National compassionate use form
15–45d medium30dRegulated under EU Directive 2001/83/EC
PPB Special Import Permit – Kenya
Kenya's Pharmacy and Poisons Board special import permit for unregistered medicines for named patients with serious medical conditions.
Form: PPB SIP Form
15–45d medium21dPharmacy and Poisons Act Cap 244
RDB Pharmacy Special Access – Rwanda
Rwanda Development Board pharmacy division special access program for unregistered medicines for patients with serious or life-threatening conditions.
Form: RDB Pharmacy Special Access Form
<15d fast14dRwanda Pharmacy Law
Romania 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 Romania.
Form: National compassionate use form
15–45d medium30dRegulated under EU Directive 2001/83/EC
Roszdravnadzor Medical Use for Unregistered Drugs (Article 47) – Russia
Russian Federal Law No. 61-FZ on Medicines Circulation Article 47 allows use of unregistered medicinal products for individual patients with serious or life-threatening conditions under Ministry of Health permission.
Form: MOH Russia Application
15–45d medium30dFederal Law No. 61-FZ on Medicines Circulation
SAHPRA Section 21 Authorization – South Africa
SAHPRA Section 21 of the Medicines and Related Substances Act allows use of unregistered medicines when no suitable registered alternative exists, for named patients or in defined settings.
Form: SAHPRA Section 21 Application
15–45d medium30dMedicines Act Section 21
Saint Kitts and Nevis MOH Special Import Authorization
Saint Kitts and Nevis Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: MOH Saint Kitts and Nevis Special Import Form
15–45d medium45dRegulated
Saint Lucia MOH Special Import Authorization
Saint Lucia Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: MOH Saint Lucia Special Import Form
15–45d medium45dRegulated
Saint Vincent and the Grenadines MOH Special Import Authorization
Saint Vincent and the Grenadines Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: MOH Saint Vincent and the Grenadines Special Import Form
15–45d medium45dRegulated
Samoa MOH Special Import Authorization
Samoa Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: MOH Samoa Special Import Form
>45d slow60dRegulated
San Marino Special Import (via EMA framework)
San Marino special import authorization for unregistered medicines using the EMA/EU regulatory framework via neighboring EU country channels.
Form: San Marino Special Import Form
<15d fast14dVia EU/EMA regulatory framework