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 (Ministère de la Santé Publique). The main governing legislative framework includes Law No. 90/035 of December 10, 1990 relating to the practice of pharmacy, supplemented by subsequent decrees and ministerial orders that regulate the registration, importation, distribution, and marketing of pharmaceuticals, medical devices, diagnostics, and related health products. All health products intended for the Cameroonian market must undergo a formal marketing authorization (autorisation de mise sur le marché, AMM) process administered by the DMP, which involves technical review by an expert evaluation committee before approval is granted.

Applicants are required to submit a structured product dossier; while Cameroon does not yet mandate full International Council for Harmonisation (ICH) Common Technical Document (CTD) format across all product categories, alignment with CTD or ACTD (ASEAN Common Technical Dossier) standards is increasingly expected and recommended for pharmaceutical submissions. A locally registered representative or a licensed pharmaceutical importer established in Cameroon is mandatory for foreign manufacturers seeking market authorization. The DMP has been undertaking gradual reforms in recent years, including efforts to harmonize regulatory processes within the Central African regional framework (CEMAC) and to strengthen pharmacovigilance systems. Medical devices and in vitro diagnostics occupy a less formalized regulatory pathway compared to pharmaceuticals, though importation controls and quality verification requirements apply. Digital health products remain subject to evolving guidance, with oversight shared between the Ministry of Public Health and telecommunications regulators.

Public procurement of health products in Cameroon is governed by the national public procurement framework established under Law No. 2006/012 of December 29, 2006 and its implementing decrees, coordinated by the Agence de Régulation des Marchés Publics (ARMP). The Ministry of Public Health is the primary procuring entity for medicines, medical devices, diagnostics, and health commodities at the central level, with the Central Procurement Unit (Centrale d'Achat des Médicaments Essentiels, CAME) serving as the main government warehouse and distribution mechanism for essential medicines and health supplies across public health facilities. Procurement processes typically follow open competitive tendering procedures, with thresholds determining whether national or international tenders are required. Regional and district health services may conduct decentralized procurement within budgetary allocations set by the central government, though the public supply chain remains predominantly centralized.

The private sector plays a significant role in health product distribution in Cameroon, with a network of licensed pharmaceutical wholesalers and retail pharmacies supplying both urban and rural markets. Donor-funded channels are critically important, particularly for HIV/AIDS, malaria, tuberculosis, and reproductive health commodities, with major contributors including the Global Fund to Fight AIDS, Tuberculosis and Malaria; USAID through the GHSC-PSM supply chain program; UNICEF; and Gavi, the Vaccine Alliance, which supports vaccine procurement and cold chain strengthening. These donors often procure through international mechanisms such as UNICEF Supply Division or the Pan American Health Organization (PAHO) Strategic Fund, bypassing standard national tender processes. There is no formal local manufacturing preference policy currently enforced in Cameroon, though the government has expressed strategic interest in developing domestic pharmaceutical production capacity in alignment with African Union and Africa CDC frameworks for pharmaceutical self-sufficiency.