Côte d'Ivoire

In Côte d'Ivoire, the primary regulatory authority for health products is the Direction de la Pharmacie, du Médicament et des Laboratoires (DPML), operating under the Ministère de la Santé, de l'Hygiène Publique et de la Couverture Maladie Universelle. The overarching legal framework is established by Loi n° 2015-533 relative à la pharmacie, which governs the registration, importation, distribution, and post-market surveillance of pharmaceuticals, medical devices, diagnostics, and related health products. All health products intended for the Ivoirian market must obtain a Marketing Authorization (Autorisation de Mise sur le Marché, AMM) prior to commercialization, granted by the DPML following a technical review of the submitted dossier. The DPML also works within the broader West African regional harmonization framework coordinated by the West African Health Organization (WAHO) and increasingly aligns with the African Medicines Regulatory Harmonization (AMRH) initiative under the Africa Medicines Agency (AMA) framework.

Applicants are required to appoint a locally registered pharmaceutical company or authorized representative domiciled in Côte d'Ivoire to submit and maintain the registration dossier. Technical dossiers are generally expected to follow the Common Technical Document (CTD) format, and submissions referencing approvals from stringent regulatory authorities (such as EMA, FDA, or WHO Prequalification) may benefit from expedited or abbreviated review pathways. For diagnostics, alignment with WHO Emergency Use Listing or prequalification is viewed favorably. Recent reforms have focused on strengthening pharmacovigilance obligations, improving transparency in the AMM process, and participating in ECOWAS-level regulatory convergence efforts. Digital health products and software-as-a-medical-device (SaMD) remain in an early regulatory definition phase, with no fully codified standalone framework yet established, though general medical device provisions under the DPML mandate apply.

Public sector procurement of health products in Côte d'Ivoire is governed primarily through the Centrale d'Achat des Médicaments Essentiels, Vaccins et Consommables Médicaux (CAMEG-CI), the national central medical stores entity responsible for the sourcing, quality assurance, storage, and distribution of essential medicines, vaccines, diagnostics, and medical consumables to public health facilities. Procurement processes are subject to the national public procurement code overseen by the Autorité Nationale de Régulation des Marchés Publics (ANRMP), which mandates competitive tendering procedures for contracts above defined thresholds. The Ministère de la Santé coordinates budget allocations and procurement planning, and public facilities are generally required to source products through CAMEG-CI channels or through approved ministry-level frameworks. Products must hold a valid AMM issued by the DPML to be eligible for public tender inclusion.

Côte d'Ivoire benefits from significant donor-funded health procurement, with major international partners including the Global Fund to Fight AIDS, Tuberculosis and Malaria, UNICEF Supply Division, USAID through its implementing mechanisms such as GHSC-PSM, and Gavi, the Vaccine Alliance, all contributing to parallel supply channels particularly for HIV, malaria, tuberculosis, and immunization programs. These channels often operate through international competitive bidding and may procure WHO-prequalified or stringent-authority-approved products directly, sometimes bypassing the standard DPML AMM requirement under specific donor or emergency frameworks. The private pharmaceutical distribution market is active, served by wholesalers and importers concentrated in Abidjan, and represents a significant share of health product access. While formal local manufacturing preference policies are not yet strongly codified, Côte d'Ivoire's participation in the African Union's Pharmaceutical Manufacturing Plan for Africa (PMPA) and regional industrialization ambitions signal growing policy interest in supporting domestic and regional production capacity.