Cameroon

The primary regulatory authority for health products in Cameroon is the Direction du Médicament et de la Pharmacie (DMP), operating under the Ministry of Public Health (MINSANTE). The principal governing legislation includes Law No. 90/035 of 10 August 1990 on Pharmaceutical Activity and its subsequent decrees, which establish the legal framework for the registration, importation, distribution, and control of pharmaceuticals, medical devices, diagnostics, and related health products. All health products intended for the Cameroonian market must undergo a formal evaluation and registration process administered by the DMP, which includes technical review of safety, quality, and efficacy data before a marketing authorization is granted. The process typically involves submission of a dossier, review by a national technical committee, and issuance of a registration certificate that is generally valid for five years and subject to renewal.

Key submission requirements include the appointment of a local legal representative or licensed importer who is authorized to act on behalf of the foreign manufacturer and assumes regulatory responsibility within the country. Dossier submissions are generally expected to follow the Common Technical Document (CTD) format, although the DMP also accepts formats aligned with regional harmonization efforts under the African Union Development Agency (AUDA-NEPAD) and the West African Health Organisation (WAHO). Cameroon is a member of the African Medicines Regulatory Harmonization (AMRH) initiative, and the country has progressively engaged with efforts to align national standards with regional frameworks. Notable recent reforms include strengthening pharmacovigilance obligations, improving post-market surveillance capacity, and incremental steps toward digitizing parts of the registration process, though implementation remains ongoing and timelines can vary considerably depending on product category and dossier completeness.

Public procurement of health products in Cameroon is centrally coordinated through MINSANTE, with the Central Purchasing Office for Essential Medicines and Medical Consumables (CENAME, Centrale d'Achat des Médicaments Essentiels et des Consommables Médicaux) serving as the primary government body responsible for the national procurement, storage, and distribution of essential medicines, medical supplies, and diagnostics. CENAME operates in conjunction with ten Regional Funds for Health Promotion (FRPS), which manage procurement and distribution at the regional level, creating a two-tier public supply chain structure. Formal public tenders are governed by the national public procurement code administered by the Autorité de Régulation des Marchés Publics (ARMP), which oversees competitive bidding processes for government contracts. Budget constraints, administrative bottlenecks, and procurement delays are recognized challenges within the public system, and international suppliers are generally required to work through a locally registered entity or authorized agent.

The private sector plays a significant role in health product access in Cameroon, with a network of licensed private wholesalers and pharmacies serving urban and peri-urban populations. Multinational pharmaceutical and device companies typically engage the market through appointed local distributors or exclusive agents with the requisite import licenses. Donor-funded procurement channels are substantial contributors to health product availability, particularly for HIV/AIDS, malaria, tuberculosis, and maternal and child health commodities. Key donor partners include the Global Fund to Fight AIDS, Tuberculosis and Malaria, USAID through its implementing partners (including PEPFAR-funded programs), UNICEF, and Gavi, the Vaccine Alliance, each of which operates procurement mechanisms that may follow their own international procurement standards independently of the national DMP registration requirement in certain circumstances. Local manufacturing capacity in Cameroon remains limited, and there is no established mandatory local manufacturing preference policy, though the government has expressed strategic interest in promoting regional and domestic pharmaceutical production in alignment with broader African Union continental health manufacturing goals.