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 established by Law No. 2015-14 of July 2, 2015, relating to medicines and other health products, supplemented by its implementing decrees. The DPM is responsible for the authorization, quality control, and post-market surveillance of pharmaceuticals, medical devices, diagnostics, and increasingly, digital health tools. Products must obtain a Marketing Authorization (Autorisation de Mise sur le Marché, AMM) prior to commercialization, a process that includes technical dossier review, laboratory analysis by the Laboratoire National de Contrôle des Médicaments (LNCM), and a formal opinion from the Commission Nationale du Médicament.

Applicants are generally required to appoint a local representative or licensed importer established in Senegal to submit and manage the dossier. Technical dossiers are accepted in formats aligned with the Common Technical Document (CTD) structure, and the DPM increasingly recognizes evaluations conducted by stringent regulatory authorities (SRAs) or approvals granted through the African Medicines Agency (AMA) framework as supporting evidence to facilitate accelerated review. Senegal is an active member of the West African Health Organisation (WAHO) and participates in the ECOWAS regional harmonization initiative, which is progressively aligning national requirements with a common regional dossier standard. Recent reforms have sought to shorten timelines for essential medicines and WHO-prequalified products, and the government has signaled commitment to strengthening regulatory capacity for medical devices and in vitro diagnostics, categories that historically have had less formalized pathways than pharmaceuticals.

Public procurement of health products in Senegal is coordinated primarily through the Ministère de la Santé et de l'Action Sociale, with the central procurement agency, la Pharmacie Nationale d'Approvisionnement (PNA), serving as the main entity responsible for purchasing, warehousing, and distributing medicines, medical supplies, and diagnostics to public health facilities nationwide. The PNA operates under framework agreements and open competitive tenders governed by the national public procurement code, overseen by the Direction des Marchés Publics (DCMP) and the Autorité de Régulation des Marchés Publics (ARMP). Procurement decisions at the facility and district level are increasingly decentralized, but strategic purchasing and large-volume tenders remain centralized through the PNA, which supplies district pharmacies and public hospitals across all 14 regions of the country.

Donor-funded procurement constitutes a substantial share of health product supply in Senegal, with major channels including the Global Fund to Fight AIDS, Tuberculosis and Malaria, USAID and its implementing partners (notably through GHSC-PSM), UNICEF Supply Division, and Gavi, the Vaccine Alliance, which funds a significant portion of the national immunization program. Products procured through these channels are often sourced from WHO-prequalified or SRA-approved suppliers and may bypass or run parallel to the standard DPM registration pathway under specific donor and government agreements. The private sector is served through licensed pharmaceutical importers and distributors, with a growing network of private pharmacies concentrated in Dakar and other urban centers. Senegal has an emerging local pharmaceutical manufacturing sector, and government policy under the Plan Sénégal Émergent actively encourages domestic production and regional manufacturing partnerships, with preferences for locally produced products being discussed within the ECOWAS framework as a long-term policy direction.