Nigeria
NAFDAC- Pathway & reliance
- Full assessment; reliance on WHO PQ & SRA/WLA; collaborative initiatives
- Indicative timeline
- ~12–18 months
- Local presence
- Required
- Language
- English
Where We Operate
Regulatory intelligence for West & Central Africa.
Entering African markets means navigating a different authority, framework, and timeline in every country. Here is a clear, country-by-country starting point — the regulator, the pathway, the timelines, and the local obligations that determine whether you can submit at all.
Note Requirements, timelines, and fees evolve rapidly as AMA, AMRH, and regional harmonization advance. The information below is indicative and updated periodically; we confirm current requirements for every active engagement.
ECOWAS · WAHO · UEMOA
West Africa
Ghana
FDA Ghana- Pathway & reliance
- Full & abridged; active in ZaZiBoNa collaborative registration
- Indicative timeline
- ~10–15 months
- Local presence
- Required
- Language
- English
Senegal
ARP- Pathway & reliance
- Full assessment; UEMOA harmonization; reliance developing
- Indicative timeline
- ~12–18 months
- Local presence
- Required
- Language
- French
Côte d’Ivoire
DPML- Pathway & reliance
- Full assessment; UEMOA framework; reliance case-by-case
- Indicative timeline
- ~12–18 months
- Local presence
- Required
- Language
- French
Benin
ABMED- Pathway & reliance
- Full assessment; UEMOA harmonization advancing
- Indicative timeline
- ~12–18 months
- Local presence
- Required
- Language
- French
Additional profiles on request: Burkina Faso, Mali, Togo, Niger, Guinea.
CEMAC · ECCAS (CEEAC)
Central Africa
Cameroon
DPML / MINSANTE- Pathway & reliance
- Full assessment; CEMAC harmonization advancing
- Indicative timeline
- ~12–24 months
- Local presence
- Required
- Language
- French / English
Gabon
DPM- Pathway & reliance
- Full assessment; CEMAC framework
- Indicative timeline
- ~12–24 months
- Local presence
- Required
- Language
- French
Republic of Congo
DPM- Pathway & reliance
- Full assessment; CEMAC framework
- Indicative timeline
- ~12–24 months
- Local presence
- Required
- Language
- French
Chad
DPML- Pathway & reliance
- Full assessment; CEMAC framework
- Indicative timeline
- ~12–24 months
- Local presence
- Required
- Language
- French
Additional profiles on request: Central African Republic, Equatorial Guinea, DR Congo.
Regional frameworks at a glance
Two integration layers, one continental horizon.
Two integration layers increasingly shape these markets. In West Africa, ECOWAS — through WAHO and, for the Francophone states, UEMOA — is driving harmonization, while ZaZiBoNa-style collaborative registration expands. In Central Africa, CEMAC and ECCAS advance pharmaceutical harmonization. Above both sits the African Medicines Agency (AMA), which over time will enable continental scientific opinions and stronger reliance.
- AMA
- ECOWAS · WAHO
- UEMOA
- ZaZiBoNa
- CEMAC
- ECCAS (CEEAC)
- WHO PQ
- WLA / SRA
Need a tailored, country-by-country strategy?
Request a market-entry assessment — including the fastest compliant pathway and reliance options for your product.