South Africa
ZASub-Saharan Africa
Regulatory Overview
South Africa is regulated by the SAHPRA. The country has 1 documented regulatory pathway for accessing unapproved or unlicensed medicines, covering named patient programs, compassionate use schemes, and special access arrangements.
Regulatory Authority
SAHPRA
Regulatory Pathways (1)
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.
Application Form: SAHPRA Section 21 Application
Legal Basis: Medicines Act Section 21
Eligibility: Serious or life-threatening condition with no locally registered alternative
Reference: SAHPRA Section 21 Guidance
Drugs Available (5)
| Drug | Access Route | Status | Lead Time |
|---|---|---|---|
| carbamazepine | — | — | — |
| Digoxin | — | — | — |
| ivermectin | — | — | — |
| prednisone | — | — | — |
| Zidovudine | — | — | — |
South Africa
| ISO Code | ZA |
| Region | Sub-Saharan Africa |
| Regulatory Authority | SAHPRA |
| Pathways | 1 documented |
| Drugs Available | 5 drug(s) |