Locally incorporated applicant
Required
Dossier lodged by a local legal entity
Registering a medicine in Ghana: what a foreign sponsor needs
Ghana's medicines authority is FDA Ghana, the Food and Drugs Authority. A foreign manufacturer cannot hold its own registration. These are the local positions the law requires, and the routes available.
Ghana
Authority: FDA Ghana · Food and Drugs Authority
Local responsible entity
Required
Accountable in-market party
Local safety contact
Required
Contactable point for the authority
Clinical trial route
National submission with reliance routes available for eligible products.
Reliance / regional
Reliance routes available. Eligibility is product-specific.
Language and dossier
English.
Watch out for
Local representative required for foreign manufacturers before filing.
Indicative. Confirmed per product as part of an assessment.
Scope Ghana →Questions about Ghana
Can a foreign company hold its own product registration in Ghana?
No. The dossier must be lodged by a locally incorporated applicant, the product needs a local responsible entity, and FDA Ghana needs a locally contactable safety point. These are statutory requirements.
What is the clinical trial route in Ghana?
National submission with reliance routes available for eligible products.
Are reliance or regional routes available in Ghana?
Reliance routes available. Eligibility is product-specific.
What language must the dossier be in for Ghana?
English.
Other markets
South AfricaSAHPRANigeriaNAFDACKenyaPPBTanzaniaTMDABotswanaBoMRAZimbabweMCAZZambiaZAMRANamibiaNMRCUgandaNDAMozambiqueANARMECôte d'IvoireAIRP
Compare all twelve side by side on the markets page, or read the AMA Continental Listing guide.
Clinical trials
FDA Ghana and ethics submissions, site activation, import permits, local safety contact.
Registration
Dossier lodgement, route selection, sameness and bridging, variations and renewals.
Local representation
MAH and Local Technical Representative coordination with licensed local partners.