BURKINA FASO
Burkina Faso is a West African country with its capital in Ouagadougou, a population of approximately 20 million, and French as its official language.
Burkina Faso is a member state of the Economic Community of West African States (ECOWAS).
Medicines may only be imported into Burkina Faso after obtaining the required marketing authorization.
Pharmaceutical Market in Burkina Faso
The African pharmaceutical market is generally characterized by a high volume of imports. Local production accounts for only approximately 3% of global pharmaceutical production, while the African market continues to expand in response to growing demand. Burkina Faso has one pharmaceutical manufacturing facility.
Furthermore, the growing burden of non-communicable diseases, in addition to the major pandemics affecting the continent, has contributed to an unprecedented demand for medicines.
Medicines Registration
Burkina Faso is a member of regional organizations, primarily the West African Economic and Monetary Union (WAEMU/UEMOA), and applies its directives on the registration of medicines. In addition, specific national regulations and country-specific requirements must be taken into account.
The registration dossier must be submitted in Common Technical Document (CTD) format and in French.
The regulatory authority responsible for medicines registration is the Faso Food and Drug Administration (Faso FDA): Faso FDA.
Depending on the dossier’s level of compliance, the medicines registration process may take between 9 and 18 months.
AREMA offers comprehensive support for medicines registration in Burkina Faso.
We provide regulatory services from the regulatory intelligence, preparation and translation of your dossier, the deposit, follow-up, and registration of your various products until the establishment of a system of pharmacovigilance and post-marketing monitoring.
To initiate any collaboration or for any consultation you can contact us by email: