Senegal

The primary regulatory authority for health products in Senegal is the Direction de la Pharmacie et du Médicament (DPM), operating under the Ministère de la Santé et de l'Action Sociale. The overarching legal framework is governed by the Loi n° 2015-14 du 26 août 2015 relative à l'exercice de la pharmacie, complemented by a series of ministerial decrees and orders that regulate the registration, importation, distribution, and post-market surveillance of pharmaceuticals, medical devices, diagnostics, and related health products. All health products intended for the Senegalese market must undergo a formal marketing authorization process administered by the DPM, which includes technical evaluation by an advisory commission before a license is granted. Products approved by stringent regulatory authorities such as the EMA, US FDA, or through WHO Prequalification may benefit from expedited review pathways, though full local registration remains mandatory.

Applicants are required to appoint a locally established legal representative or authorized distributor registered in Senegal to submit and manage the dossier on behalf of the manufacturer. Dossier submissions are generally expected to follow the Common Technical Document (CTD) format, and WHO-prequalified products or those approved under recognized international standards may be eligible for abbreviated review. Labeling must comply with national requirements, including French-language packaging and local address information. Senegal is also an active member of the Economic Community of West African States (ECOWAS) and participates in regional harmonization initiatives under the West African Health Organisation (WAHO), which is progressively working toward a harmonized regional regulatory framework to streamline submissions across member states. Recent reforms have emphasized strengthening pharmacovigilance systems and improving the transparency and predictability of review timelines.

Public procurement of health products in Senegal is centrally coordinated through the Pharmacie Nationale d'Approvisionnement (PNA), a public agency responsible for the purchasing, storage, and distribution of essential medicines, medical devices, and diagnostics to public health facilities nationwide. The PNA operates under the oversight of the Ministère de la Santé et de l'Action Sociale and conducts competitive national tenders in accordance with the national public procurement code administered by the Direction Centrale des Marchés Publics (DCMP). Procurement decisions at the public level prioritize products registered with the DPM and may require compliance with WHO Good Manufacturing Practices (GMP) or equivalent standards. Decentralized procurement also occurs at the regional and district health levels through the network of regional medical stores (Pharmacies Régionales d'Approvisionnement), though large-volume national tenders remain the primary entry point for suppliers.

Senegal benefits significantly from donor-funded and multilateral procurement channels, which represent a substantial portion of health commodity financing in the country. Key partners include the Global Fund to Fight AIDS, Tuberculosis and Malaria, UNICEF Supply Division, USAID through its implementing mechanisms such as the Global Health Supply Chain Program, and Gavi, the Vaccine Alliance, which supports immunization commodities. Products procured through these channels are often sourced from WHO-prequalified manufacturers and may enter the country under special import waivers or facilitated customs procedures. The Senegalese government has articulated ambitions to strengthen local and regional pharmaceutical manufacturing capacity, aligned with the broader African Union Pharmaceutical Manufacturing Plan for Africa and the ECOWAS regional strategy, with incentives under discussion to favor locally produced health products in public tenders where quality and supply reliability can be assured.