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 principal governing legislation includes Law No. 90/035 of 10 August 1990 on the practice of pharmacy, supplemented by various ministerial orders and decrees governing the importation, registration, distribution, and sale of medicines, medical devices, diagnostics, and related health products. All health products intended for the Cameroonian market must undergo a formal marketing authorization process administered by the DPML, which evaluates dossiers for quality, safety, and efficacy before granting approval. Cameroon is also a member of the Central African Economic and Monetary Community (CEMAC) and participates in ongoing regional harmonization efforts through the Agence de la CEMAC pour la Régulation des Médicaments (ACAME), which aims to streamline registration across member states.

Applicants seeking marketing authorization are required to appoint a locally established legal representative or authorized distributor to act as the responsible entity in Cameroon. Technical dossiers are generally expected to follow the Common Technical Document (CTD) format, although full alignment with ICH guidelines is not yet uniformly enforced and adaptations are accepted in practice. Supporting documentation typically includes evidence of registration in the country of manufacture, certificates of pharmaceutical product (CPP) issued by a recognized regulatory authority, good manufacturing practice (GMP) certification, labeling in French and English reflecting Cameroon's bilingual status, and pharmacovigilance commitments. The DPML has pursued incremental reforms to digitize parts of its submission and tracking processes, and Cameroon has expressed commitment to adopting regional harmonization tools under ACAME to reduce duplication and accelerate access to quality-assured health products.

Public procurement of health products in Cameroon is centrally coordinated through the Ministry of Public Health, with the Centrale d'Achat des Médicaments Essentiels et des Consommables Médicaux (CENAME) serving as the national essential medicines procurement and distribution agency. CENAME operates as the principal wholesaler for the public health system, supplying provincial and district-level stores (CAPP and CAPR networks) that in turn distribute to public health facilities across the country's ten regions. Procurement processes are governed by Cameroon's public procurement code, overseen by the Autorité de Régulation des Marchés Publics (ARMP), which mandates competitive tendering for contracts above defined thresholds. The Ministry of Public Health's budget allocation for health commodities, though growing, remains constrained, making timely payment to suppliers a persistent challenge and creating reliance on both government appropriations and external financing.

Cameroon's health commodity supply chain is significantly supported by international donors and multilateral organizations. The Global Fund to Fight AIDS, Tuberculosis and Malaria funds a substantial portion of HIV, TB, and malaria-related health product procurement, often channeled through designated principal recipients and implementing partners. UNICEF, USAID through its implementing mechanisms such as the Global Health Supply Chain Program (GHSC), and Gavi, the Vaccine Alliance also play important roles in financing and procuring vaccines, diagnostics, and essential medicines for Cameroon's public health programs. The private pharmaceutical sector is active and commercially competitive, with products distributed through licensed private wholesalers and retail pharmacies operating in urban and peri-urban areas. While Cameroon does not yet have a fully formalized local manufacturing preference policy, there is government-level interest in developing domestic pharmaceutical manufacturing capacity in alignment with the African Union's Pharmaceutical Manufacturing Plan for Africa, and locally manufactured products may benefit from reduced import duties and facilitated regulatory pathways as these policies evolve.