Locally incorporated applicant
Required
Dossier lodged by a local legal entity
Veltrion Laboratories › South Africa
Registering a medicine in South Africa: what a foreign sponsor needs
South Africa's medicines authority is SAHPRA, the South African Health Products Regulatory Authority. A foreign manufacturer cannot hold its own registration. These are the local positions the law requires, and the routes available.
South Africa
Authority: SAHPRA · South African Health Products Regulatory Authority
Local responsible entity
Required
Accountable in-market party
Local safety contact
Required
Contactable point for the authority
Clinical trial route
Predetermined submission cycles, not rolling. Checklist targeted within 3 weeks of receipt; Clinical Trial Committee recommendation targeted within 10 weeks of the submission due date. Additional investigators, sites and protocol amendments approximately 6 weeks.
Reliance / regional
Formalised reliance procedure using AMA Framework assessments. Parallel submission during the continental process is not accepted.
Language and dossier
English. CTD format.
Watch out for
Missing a submission cycle costs a full cycle. Unfamiliar investigational products may be referred to external reviewers, extending timelines.
SAHPRA timelines above are the authority's published targets. All other fields are indicative and confirmed per product.
Scope South Africa →Questions about South Africa
Can a foreign company hold its own product registration in South Africa?
No. The dossier must be lodged by a locally incorporated applicant, the product needs a local responsible entity, and SAHPRA needs a locally contactable safety point. These are statutory requirements.
What is the clinical trial route in South Africa?
Predetermined submission cycles, not rolling. Checklist targeted within 3 weeks of receipt; Clinical Trial Committee recommendation targeted within 10 weeks of the submission due date. Additional investigators, sites and protocol amendments approximately 6 weeks.
Are reliance or regional routes available in South Africa?
Formalised reliance procedure using AMA Framework assessments. Parallel submission during the continental process is not accepted.
What language must the dossier be in for South Africa?
English. CTD format.
Other markets
Compare all twelve on the interactive requirements map, or read the AMA Continental Listing guide.