DRC

The primary regulatory authority for health products in the Democratic Republic of Congo (DRC) is the Direction de la Pharmacie, du Médicament et des Plantes Médicinales (DPMED), operating under the Ministère de la Santé Publique, Hygiène et Prévention. The principal legal framework is established by the Loi-Cadre no. 18/035 of December 2018 on public health, supplemented by ministerial decrees and ordinances governing the registration, importation, distribution, and control of pharmaceuticals, medical devices, diagnostics, and related health products. All health products intended for sale or distribution in the DRC must undergo a formal registration process with DPMED, which includes a technical evaluation of quality, safety, and efficacy. The registration committee convenes periodically to review dossiers, and conditional or provisional authorizations may be granted for products addressing urgent public health needs.

Applicants are required to appoint a locally established legal representative or importer of record to submit and maintain a product registration file. Dossiers are generally expected to follow the Common Technical Document (CTD) format, although the DRC regulatory system has historically accepted adapted formats, particularly for products already registered by stringent regulatory authorities (SRAs) such as the EMA, US FDA, or WHO-prequalified products, which may benefit from an expedited review pathway. Key submission requirements include certificates of pharmaceutical product (CPP) from the country of manufacture, good manufacturing practice (GMP) certificates, a summary of product characteristics, labeling in French, and evidence of marketing authorization in the country of origin. In recent years, the DRC has engaged with the African Medicines Regulatory Harmonisation (AMRH) initiative and the African Union's African Medicines Agency (AMA) framework, signaling an intention to progressively align national procedures with regional harmonization standards, although full implementation remains in progress.

Public procurement of health products in the DRC is managed through a centralized yet operationally fragmented structure. The Ministère de la Santé Publique, Hygiène et Prévention holds overall policy authority, while the Centrale d'Achat des Médicaments Essentiels (CAMELU) serves as the primary public-sector procurement and distribution body for essential medicines and health supplies at the national level. Procurement processes are subject to the general public procurement law (Loi no. 10/010 of April 2010 and its implementing regulations), overseen by the Direction Générale du Contrôle des Marchés Publics (DGCMP). The DRC's health system is organized across national, provincial, and health zone levels, and procurement decisions can occur at multiple tiers, creating coordination challenges. National tender processes are typically open to registered local importers and distributors, and products must hold valid DPMED registration to be eligible for public procurement. Provincial health divisions (Divisions Provinciales de la Santé) also play a role in local procurement and distribution planning.

Given the significant financing gap in the public health budget, donor-funded procurement channels represent a substantial portion of total health product supply in the DRC. Major international partners including the Global Fund to Fight AIDS, Tuberculosis and Malaria, USAID through its implementing mechanisms such as PEPFAR and PMI, UNICEF, Gavi the Vaccine Alliance, and the World Bank finance and coordinate large volumes of health commodities, often procured through international competitive tendering using their own procurement procedures. Products procured through these channels are frequently WHO-prequalified or SRA-approved, and may enter the country under specific import waivers or humanitarian exemptions that differ from standard DPMED registration requirements. The private commercial sector, served by a network of licensed importers and pharmaceutical wholesalers concentrated primarily in Kinshasa, operates in parallel. Local manufacturing capacity remains very limited, and while the government has expressed policy interest in promoting domestic production as part of broader African Union and Africa CDC frameworks, no formal local manufacturing preference policy with binding procurement preferences is currently in force.