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 Ministry of Public Health, Hygiene and Prevention. The principal legal framework is established by the Loi Pharmaceutique (Law No. 15/025 of 2015) and its associated ministerial decrees, which govern the registration, importation, distribution, and post-market surveillance of pharmaceuticals, medical devices, diagnostics, and related health products. All health products must undergo a formal registration process prior to commercialization, which involves submission of a technical dossier to the DPPM, evaluation by a national technical committee, and issuance of a marketing authorization. Products approved by stringent regulatory authorities (SRAs) recognized by the WHO may benefit from an accelerated or abridged review pathway, though this process remains inconsistently applied in practice.

Applicants are generally required to appoint a local authorized representative or in-country distributor registered with the DPPM as a condition of dossier submission. Technical dossiers should align with the Common Technical Document (CTD) format, and the DPPM increasingly references WHO prequalification and African Union Development Agency (AUDA-NEPAD) African Medicines Regulatory Harmonization (AMRH) standards as benchmarks for submission quality. Key submission requirements typically include product quality, safety, and efficacy data, certificates of pharmaceutical product (CPP) from the country of origin, labeling in French, and evidence of good manufacturing practice (GMP) compliance. The DRC is a member of the East African Community (EAC) harmonization initiative and participates in regional convergence efforts under the African Medicines Agency (AMA) framework, though full integration of harmonized procedures remains an ongoing process. Reforms in recent years have focused on strengthening pharmacovigilance systems and digitizing registration records, although implementation capacity continues to be a significant constraint.

Public sector procurement in the DRC is characterized by a centralized-yet-fragmented structure. The Ministry of Public Health, Hygiene and Prevention holds overarching authority for health commodity policy, while the Centrale d'Achat des Médicaments Essentiels (CAMEG) and its provincial counterparts serve as the principal public procurement entities for essential medicines and health products. National tenders and framework contracts are managed through the Direction de l'Administration et des Finances (DAF) within the Ministry, in coordination with the Autorité de Régulation des Marchés Publics (ARMP), which provides general oversight of public procurement in accordance with the public procurement law. The DRC's health system operates across 26 provinces, and decentralization reforms have progressively delegated certain procurement and distribution responsibilities to provincial health divisions (Divisions Provinciales de la Santé), creating variation in procurement practices across regions. Systemic challenges including limited domestic financing, infrastructure deficits, and supply chain weaknesses mean that public procurement capacity is heavily dependent on external support.

The private sector and donor-funded channels are dominant forces in health product supply in the DRC. Major international financing partners including the Global Fund to Fight AIDS, Tuberculosis and Malaria, Gavi the Vaccine Alliance, USAID through its implementing mechanisms (such as GHSC-PSM and various bilateral programs), UNICEF, and the World Bank collectively fund a substantial proportion of health commodity procurement. These partners often procure through international competitive tender processes, applying their own supplier qualification requirements, including WHO prequalification or SRA approval, which effectively creates a parallel procurement track operating alongside government systems. The PEPFAR program represents a particularly significant channel for HIV-related commodities. Local manufacturing in the DRC remains nascent, with only a limited number of domestic producers, and there is currently no robust formal preference policy for locally manufactured products, though national health strategy documents express aspirational support for developing local production capacity in alignment with the African Union's Pharmaceutical Manufacturing Plan for Africa (PMPA).