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 (DPPM), operating under the Ministère de la Santé Publique, Hygiène et Prévention. The overarching legal framework is anchored in the Loi-Cadre n° 18/035 du 13 décembre 2018 relative à la santé publique, complemented by ordinances and ministerial decrees governing the registration, importation, distribution, and post-market surveillance of pharmaceuticals, medical devices, in-vitro diagnostics, and related health products. All health products intended for the Congolese market must undergo a formal marketing authorization (autorisation de mise sur le marché, AMM) process administered by the DPPM, which involves technical dossier review, laboratory analysis where applicable, and inspection of manufacturing conditions. The DPPM also coordinates with the Laboratoire Pharmaceutique de Kinshasa (LABOPHAR) for quality control testing, and review timelines are subject to significant variability due to institutional capacity constraints.

Applicants are required to appoint a locally registered representative or importer who assumes legal responsibility for the product on the Congolese market. Dossier submissions are generally expected to follow the Common Technical Document (CTD) format, although full harmonization with international standards remains a work in progress. The DRC is a member of the African Union and has committed to aligning with the African Medicines Regulatory Harmonization (AMRH) initiative, and the country participates in efforts coordinated through the African Medicines Agency (AMA) framework. For medical devices and diagnostics, specific guidance remains less codified than for pharmaceuticals, with registration requirements applied on a case-by-case basis. Recent reforms have focused on strengthening post-market surveillance, combating substandard and falsified products, and digitalizing portions of the registration workflow, though implementation is ongoing and applicants are advised to engage directly with the DPPM early in the process.

Public procurement of health products in the DRC is managed through a decentralized yet centrally coordinated structure. At the national level, the Ministère de la Santé Publique, Hygiène et Prévention oversees health commodity planning and policy, while the Autorité de Régulation des Marchés Publics (ARMP) provides the overarching legal and procedural framework for public tenders in accordance with the Loi n° 10/010 du 27 avril 2010 relative aux marchés publics. The national drug supply and distribution system relies heavily on the Centrale d'Achat des Médicaments Essentiels (CAMES) and its provincial counterparts, the Centrales de Distribution Régionales (CDRs), which procure and distribute essential medicines and health commodities to public health facilities across the country's 26 provinces. Procurement at the provincial and health zone levels is intended to follow national frameworks, but in practice capacity varies widely, and coordination challenges between central and decentralized entities are common.

Due to significant gaps in domestic public financing, donor-funded procurement channels constitute a critical and dominant segment of the DRC health market. Major multilateral partners including UNICEF, the Global Fund to Fight AIDS, Tuberculosis and Malaria, USAID through its implementing mechanisms, and Gavi, the Vaccine Alliance collectively finance and procure a substantial share of essential medicines, vaccines, diagnostics, and medical supplies used in the country. These procurements are typically conducted according to the procurement policies of the respective donor organizations, which require WHO prequalification or equivalent stringent regulatory authority approval for eligible products. The private sector, including mission-based health networks such as those coordinated by the Bureau Diocésain des Oeuvres Médicales (BDOM), also plays a significant role in health product distribution, particularly in areas underserved by the public system. Formal local manufacturing preference policies are not yet robustly enforced, though the DRC government has expressed strategic interest in promoting domestic pharmaceutical production as part of broader industrial policy ambitions aligned with the African Union's Pharmaceutical Manufacturing Plan for Africa (PMPA).