Table 1.
Organisational set-up and functions performed by NMRAs in Africa
Source: Various Reports, Websites; including national government websites, WHO websites, African Union websites, and general web resources U information not available
| Country | Organisational set up | Product Assessment & registration | Licencing manufacturers | Licencing wholesalers, distributors | Imports and exports control | Inspection of manufacturing establishments | Inspection of distribution channels/Outlets | Quality control laboratory |
|---|---|---|---|---|---|---|---|---|
| Algeria | Direction de la Pharmacie et du Médicament. Ministère de la Santé, de la Population et de la Réforme Hospitalière; MoH | U | U | U | U | U | U | ✔ |
| Angola | Direcao Nacional de Medicamentos e Equipmentos, Ministerio de Saude; MoH | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | U |
| Benin | Direction de la Pharmacie et des explorations diagnostics; MoH | U | U | U | U | U | U | U |
| Botswana | Drug Regulatory Services, Ministry of Health and Wellness; MoH | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ |
| Burkina Faso | Direction Générale de la Pharmacie, du Médicament et des Laboratoires; Semi-Autonomous | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ |
| Burundi | Direction de la pharmacie, du Meicament et des Laboratories; MoH | ✔ | ✔ | ✔ | ✔ | U | U | ✔ |
| Cabo Verde | Agência de Regulação e Supervisão dos Produtos Farmacêuticos e Alimentares; MoH | U | ✔ | U | ✔ | U | U | U |
| Cameroon | Direction de la Pharmacie, du Médicament et des Laboratoires; MoH | U | U | U | U | U | U | U |
| Central African Republic | Direction des services Pharmaceutiques des laboratoires et de la Médecine Traditionnelle, Ministère de la Santé publique et de la Population; MoH | U | U | U | U | U | U | U |
| Chad | Direction Générale de la Pharmacie et Laboratoire, Ministère de la Santé Publique; MoH | U | U | ✔ | ✔ | U | U | U |
| Comoros | Direction des Laboratoires et des Pharmacies; MoH | U | U | U | U | U | U | U |
| Congo | Direction des Pharmacies, du Médicament et des Laboratoires. Ministère de la Santé Publique et des Affairs Sociales; MoH | U | U | U | U | U | U | U |
| Côte d’Ivoire | Direction de la Pharmacie et du Médicament. Ministre de la Sante et de l’Hygiene Publique; MoH | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ |
| DR Congo | Direction de la Pharmacie et du Médicament. Ministère de la Santé Publique; MoH | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ |
| Djibouti | Direction du Médicament et de la Pharmacie, Ministère de la Santé; MoH | U | U | U | U | U | U | U |
| Egypt | Egyptian Drug Authority; MoH | U | U | U | U | U | U | ✔ |
| Equatorial Guinea | Direction Générale de Pharmacie et Médecine Traditionnelle; MoH | U | U | ✔ | ✔ | U | U | U |
| Eritrea | National Medicine and Food Administration; MoH | U | U | U | U | U | U | U |
| Ethiopia | Food, Medicine and Health Care Administration and Control of Ethiopia; Semi-Autonomous | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ |
| Gabon | Direction Médicament et de la Pharmacie; MoH | U | U | U | U | U | U | U |
| Gambia | Newly established Medicines Control Agency; MoH | U | ✔ | U | U | U | U | U |
| Ghana | Food and Drugs Authority; Semi-Autonomous | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ |
| Republic of Guinea | Direction Nationale de la Pharmacie et du Laboratoire; MoH | U | ✔ | U | ✔ | U | U | U |
| Guinea Bissau | Direction de services Pharmaceutiques, de Laboratoire et du Médicament; MoH | U | U | U | ✔ | U | U | U |
| Kenya | Pharmacy and Poisons Board; Semi-Autonomous | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ |
| Lesotho | Ministry of Health; MoH | U | U | U | U | U | U | U |
| Liberia | Liberia Medicines and Health Products Regulatory Authority; MoH | U | ✔ | U | U | U | U | ✔ |
| Libya | Pharmacy Management Department, Ministry of Health; MoH | U | U | U | U | U | U | U |
| Madagascar | Direction de la Phamacie, des Laboratoires et de la Médecine Traditionnelle; MoH | U | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ |
| Malawi | Pharmacy, Medicines and Poisons Board; MoH | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ |
| Mali | Direction de la Pharmacie et des Médicaments, Ministre de la Sante et de l’Hygiene Publique; MoH | U | ✔ | U | U | U | U | ✔ |
| Mauritania | Direction de la Pharmacie et du Médicament Ministère de la Santé Publique et des Affaires Sociales; MoH | U | U | U | U | U | U | U |
| Mauritius | Pharmacy Board, Ministry of Health and Quality of Life; MoH | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ |
| Morocco | Direction du Médicament et de la Pharmacie; Semi-Autonomous | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ |
| Mozambique | Departamento Farmacêutico, Ministério da Saúde; MoH | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ |
| Namibia | Namibia Medicines Regulatory Council; MoH | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ |
| Niger | Direction de la Pharmacie, des Laboratoires et de la Pharmacopée Traditionnelle, Ministere de la Sante Publique; MoH | U | ✔ | U | ✔ | U | U | U |
| Nigeria | National Agency for Food and Drug Administration and Control; MoH | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ |
| Rwanda | Department of Pharmaceutical Services, Ministry of Health; MoH | ✔ | U | ✔ | ✔ | ✔ | ✔ | ✔ |
| Sahrawi Republic | No NMRA identified | U | U | U | U | U | U | U |
| São Tomé and Príncipe | Direction de la Pharmacie et du Médicament Ministère de la Santé; MoH | U | U | U | U | U | U | U |
| Senegal | Direction de la Pharmacie et du Médicament, Ministère de la Santé et de l’Action sociale; MoH | U | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ |
| Seychelles | Medicines Regulation Unit, Public Health Authority, Ministry of Health; MoH | U | U | U | U | U | U | U |
| Sierra Leone | Pharmacy Board of Sierra Leone; Semi-Autonomous | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ |
| Somalia | Pharmaceutical and Medical Department, Ministry of Health; MoH | U | U | U | U | U | U | U |
| South Africa | Medicines Control Council; Semi-Autonomous | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ |
| South Sudan | Food and Drugs Control Authority, South Sudan; Semi-Autonomous | U | U | U | U | U | U | U |
| Sudan | National Medicines and Poisons Board; Semi-Autonomous | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ |
| Swaziland | Pharmaceutical Services Department, Ministry of Health; MoH | ✔ | ✔ | ✔ | ✔ | U | U | U |
| Togo | Direction des Pharmacies, des Laboratoires et des Equipements Technique, MINISTRE DE LA SANTE ET DE LA PROTECTION SOCIALE; MoH | U | ✔ | U | ✔ | U | U | U |
| Tunisia | Direction de la Pharmacie et du Médicament; Semi-Autonomous | U | ✔ | U | U | U | U | ✔ |
| Uganda | National Drugs Authority; Semi-Autonomous | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ |
| UR of Tanzania | 1. Tanzania Food and Drugs Authority; Semi-Autonomous | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ |
| 2. Zanzibar Food, Drugs and Cosmetics Board; Semi-Autonomous | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | |
| Zambia | Zambia Medicines Regulatory Agency; Semi-Autonomous | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ |
| Zimbabwe | Medicines Control Agency Zimbabwe; Semi-Autonomous | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ |
| Country | Organisational set up | Market surveillance | Safety surveillance | Control of drug promotion & advertisement | Control of clinical trials | International cooperation & harmonization | Quality management systems | |
|---|---|---|---|---|---|---|---|---|
| Algeria | Direction de la Pharmacie et du Médicament. Ministère de la Santé, de la Population et de la Réforme Hospitalière; MoH | U | U | U | U | U | U | |
| Angola | Direcao Nacional de Medicamentos e Equipmentos, Ministerio de Saude; MoH | U | U | U | U | U | U | |
| Benin | Direction de la Pharmacie et des explorations diagnostics; MoH | U | U | U | U | U | ✔ | |
| Botswana | Drug Regulatory Services, Ministry of Health and Wellness; MoH | ✔ | U | U | U | U | ✔ | |
| Burkina Faso | Direction Générale de la Pharmacie, du Médicament et des Laboratoires; Semi-Autonomous | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | |
| Burundi | Direction de la pharmacie, du Meicament et des Laboratories; MoH | U | U | U | U | U | ✔ | |
| Cabo Verde | Agência de Regulação e Supervisão dos Produtos Farmacêuticos e Alimentares; MoH | U | ✔ | ✔ | ✔ | U | ✔ | |
| Cameroon | Direction de la Pharmacie, du Médicament et des Laboratoires; MoH | U | U | U | U | U | U | |
| Central African Republic | Direction des services Pharmaceutiques des laboratoires et de la Médecine Traditionnelle, Ministère de la Santé publique et de la Population; MoH | U | U | U | U | U | U | |
| Chad | Direction Générale de la Pharmacie et Laboratoire, Ministère de la Santé Publique; MoH | U | U | U | U | U | U | |
| Comoros | Direction des Laboratoires et des Pharmacies; MoH | U | U | U | U | U | U | |
| Congo | Direction des Pharmacies, du Médicament et des Laboratoires. Ministère de la Santé Publique et des Affairs Sociales; MoH | U | U | U | U | U | U | |
| Côte d’Ivoire | Direction de la Pharmacie et du Médicament. Ministre de la Sante et de l’Hygiene Publique; MoH | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | |
| DR Congo | Direction de la Pharmacie et du Médicament. Ministère de la Santé Publique; MoH | U | U | U | U | U | U | |
| Djibouti | Direction du Médicament et de la Pharmacie, Ministère de la Santé; MoH | U | U | U | U | U | U | |
| Egypt | Egyptian Drug Authority; MoH | U | U | U | U | U | U | |
| Equatorial Guinea | Direction Générale de Pharmacie et Médecine Traditionnelle; MoH | U | U | U | U | U | U | |
| Eritrea | National Medicine and Food Administration; MoH | U | U | U | U | U | U | |
| Ethiopia | Food, Medicine and Health Care Administration and Control of Ethiopia; Semi-Autonomous | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | |
| Gabon | Direction Médicament et de la Pharmacie; MoH | U | U | U | U | ✔ | U | |
| Gambia | Newly established Medicines Control Agency; MoH | U | ✔ | U | U | ✔ | U | |
| Ghana | Food and Drugs Authority; Semi-Autonomous | ✔ | ✔ | ✔ | ✔ | ✔ | U | |
| Republic of Guinea | Direction Nationale de la Pharmacie et du Laboratoire; MoH | U | ✔ | ✔ | U | ✔ | U | |
| Guinea Bissau | Direction de services Pharmaceutiques, de Laboratoire et du Médicament; MoH | U | ✔ | ✔ | U | ✔ | U | |
| Kenya | Pharmacy and Poisons Board; Semi-Autonomous | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | |
| Lesotho | Ministry of Health; MoH | U | U | U | U | ✔ | U | |
| Liberia | Liberia Medicines and Health Products Regulatory Authority; MoH | U | ✔ | ✔ | ✔ | ✔ | U | |
| Libya | Pharmacy Management Department, Ministry of Health; MoH | U | U | U | U | U | U | |
| Madagascar | Direction de la Phamacie, des Laboratoires et de la Médecine Traditionnelle; MoH | U | U | U | U | ✔ | U | |
| Malawi | Pharmacy, Medicines and Poisons Board; MoH | U | U | U | U | ✔ | ||
| Mali | Direction de la Pharmacie et des Médicaments, Ministre de la Sante et de l’Hygiene Publique; MoH | U | ✔ | ✔ | ✔ | ✔ | U | |
| Mauritania | Direction de la Pharmacie et du Médicament Ministère de la Santé Publique et des Affaires Sociales; MoH | U | U | U | U | U | U | |
| Mauritius | Pharmacy Board, Ministry of Health and Quality of Life; MoH | U | U | U | U | ✔ | U | |
| Morocco | Direction du Médicament et de la Pharmacie; Semi-Autonomous | ✔ | ✔ | U | U | U | U | |
| Mozambique | Departamento Farmacêutico, Ministério da Saúde; MoH | U | U | U | U | ✔ | U | |
| Namibia | Namibia Medicines Regulatory Council; MoH | U | U | U | U | ✔ | U | |
| Niger | Direction de la Pharmacie, des Laboratoires et de la Pharmacopée Traditionnelle, Ministere de la Sante Publique; MoH | U | ✔ | U | ✔ | ✔ | U | |
| Nigeria | National Agency for Food and Drug Administration and Control; MoH | ✔ | ✔ | U | ✔ | ✔ | U | |
| Rwanda | Department of Pharmaceutical Services, Ministry of Health; MoH | U | U | U | U | ✔ | ✔ | |
| Sahrawi Republic | No NMRA identified | U | U | U | U | U | U | |
| São Tomé and Príncipe | Direction de la Pharmacie et du Médicament Ministère de la Santé; MoH | U | U | U | U | ✔ | U | |
| Senegal | Direction de la Pharmacie et du Médicament, Ministère de la Santé et de l’Action sociale; MoH | U | U | ✔ | ✔ | ✔ | U | |
| Seychelles | Medicines Regulation Unit, Public Health Authority, Ministry of Health; MoH | U | U | U | U | ✔ | U | |
| Sierra Leone | Pharmacy Board of Sierra Leone; Semi-Autonomous | ✔ | U | U | U | ✔ | U | |
| Somalia | Pharmaceutical and Medical Department, Ministry of Health; MoH | U | U | U | U | ✔ | U | |
| South Africa | Medicines Control Council; Semi-Autonomous | ✔ | ✔ | ✔ | ✔ | ✔ | U | |
| South Sudan | Food and Drugs Control Authority, South Sudan; Semi-Autonomous | U | U | U | U | ✔ | U | |
| Sudan | National Medicines and Poisons Board; Semi-Autonomous | ✔ | ✔ | U | U | ✔ | U | |
| Swaziland | Pharmaceutical Services Department, Ministry of Health; MoH | U | U | U | U | ✔ | U | |
| Togo | Direction des Pharmacies, des Laboratoires et des Equipements Technique, MINISTRE DE LA SANTE ET DE LA PROTECTION SOCIALE; MoH | U | ✔ | ✔ | ✔ | ✔ | U | |
| Tunisia | Direction de la Pharmacie et du Médicament; Semi-Autonomous | U | U | U | U | U | U | |
| Uganda | National Drugs Authority; Semi-Autonomous | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | |
| UR of Tanzania | 1. Tanzania Food and Drugs Authority; Semi-Autonomous | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | |
| 2. Zanzibar Food, Drugs and Cosmetics Board; Semi-Autonomous | ✔ | ✔ | U | U | ✔ | ✔ | ||
| Zambia | Zambia Medicines Regulatory Agency; Semi-Autonomous | ✔ | ✔ | ✔ | ✔ | ✔ | U | |
| Zimbabwe | Medicines Control Agency Zimbabwe; Semi-Autonomous | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ |