Cameroon

The primary regulatory authority for health products in Cameroon is the Direction de la Pharmacie, du Médicament et des Laboratoires (DPML), operating under the Ministry of Public Health. The overarching legal framework is grounded in Law No. 90/035 of December 1990 on pharmaceutical activity, supplemented by various ministerial orders and decrees governing the importation, registration, distribution, and post-market surveillance of pharmaceuticals, medical devices, diagnostics, and related health products. All health products intended for the Cameroonian market must undergo a formal registration process administered by the DPML, which includes technical evaluation of safety, efficacy, and quality. Marketing authorization is mandatory prior to commercialization, and products without valid registration risk seizure and sanctions.

Applicants are required to appoint a locally established legal representative or licensed pharmaceutical distributor to submit and manage registration dossiers on their behalf. Dossiers are generally expected to follow the Common Technical Document (CTD) format, and regional harmonization efforts under the Economic Community of Central African States (ECCAS) and the African Medicines Regulatory Harmonization (AMRH) initiative are progressively influencing submission standards. Supporting documentation typically includes certificates of pharmaceutical product (CPP) issued by the country of origin, Good Manufacturing Practice (GMP) certificates, product labeling in French (the dominant official language for regulatory purposes), and, where applicable, clinical or performance data. In recent years, Cameroon has taken steps to align with broader African Union regulatory harmonization frameworks, including engagement with the African Medicines Agency (AMA), though full implementation of harmonized pathways remains ongoing. Medical devices and in-vitro diagnostics are subject to registration requirements distinct from pharmaceuticals, though the regulatory infrastructure for these categories is still maturing relative to medicines oversight.

Public procurement of health products in Cameroon is coordinated primarily through the Ministry of Public Health, with the Central Purchasing Office for Essential Medicines and Medical Consumables (Centrale d'Achat des Médicaments Essentiels, des Consommables et Équipements Médicaux, CENAME) serving as the principal state procurement agency for pharmaceuticals and medical supplies destined for the public health system. CENAME operates under ministerial oversight and supplies provincial and district health facilities through a network of regional essential medicines stores (CAPP, or Centres d'Approvisionnement Pharmaceutique Provinciaux). Tenders for public procurement are subject to national public procurement regulations administered by the Autorité de Régulation des Marchés Publics (ARMP), which enforces competitive bidding requirements, transparency obligations, and contract award procedures. Cameroon operates as a unitary state, so procurement authority is centralized at the national level, though decentralized health districts have limited direct purchasing capacity.

The private pharmaceutical and health product market in Cameroon is substantial, served by a network of licensed importers, wholesalers, and retail pharmacies operating under DPML oversight. Parallel to the public system, significant volumes of health commodities are channeled through donor-funded and multilateral procurement mechanisms. Organizations such as UNICEF, the Global Fund to Fight AIDS, Tuberculosis and Malaria, the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) via USAID, and Gavi, the Vaccine Alliance play important roles in financing and supplying medicines, vaccines, diagnostics, and health commodities, particularly for priority disease programs. These donor channels often procure through international competitive tendering using WHO prequalification or stringent regulatory authority (SRA) approval as eligibility criteria. Cameroon does not currently enforce strong formal local manufacturing preference policies in public procurement, though national health strategies rhetorically support strengthening domestic pharmaceutical production capacity in alignment with the African Union's Pharmaceutical Manufacturing Plan for Africa (PMPA).