glossary with core terms regarding EU MDR and IVDR

[Glossary] Africa Standards Harmonization: The terms you should know


All terms regarding the regulatory harmonization in Africa that you need to know



African Medicines Agency



African Medicines Regulatory Harmonization. The initiative that provide leadership in creating an enabling regulatory environment for pharmaceutical sector development in Africa



African Union. It comprises five regions and has 55 members: Central Africa (9 states), Eastern Africa (14 states), Northern Africa (7 states), Southern Africa (10 states), and Western Africa (15 states)



African Union Commission



African Union Development Agency. Coordinate and execute regional and continental projects to promote regional integration towards the accelerated realization



Pharmaceutical Manufacturing Plan for Africa



National Medicines Regulatory Authorities. Responsible for regulatory functions such as marketing authorization, pharmacovigilance, market surveillance quality control, clinical trials, licensing, laboratory testing.



Regional Economic Communities. The AU recognized eight RECs:

  • UMA (Arab Maghreb Union)
  • COMESA (Common Market for Eastern and Southern Africa)
  • CEN-SAD (Community of Sahel-Saharan States)
  • EAC (East African Community)
  • ECCAS (Economic Community of Central African States)
  • ECOWAS (Economic Community of West African States)
  • IGAD (Intergovernmental Authority on Development)
  • SADC (Southern African Development Community)



Regional Centers of Regulatory Excellence. The AUDA-NEPAD designated 11 RCOREs:

  • Ghana – Pharmacovigilance
  • Kenya – Pharmacovigilance
  • Tanzania – Regulatory functions training
  • Nigeria – Regulatory functions training
  • South Africa – Quality assurance and control of medicines
  • Nigeria – Quality assurance and control of medicines
  • Zimbabwe – Medicine registration, evaluation, quality assurance/ control, clinical trials oversight
  • Uganda – Licensing (manufacture, import, export, distribute), inspection and surveillance
  • Burkina Faso – Clinical trials oversight
  • Ghana – Registration, evaluation, clinical trials oversight
  • Tanzania – Medicine evaluation and registration



United Nations Economic Commission for Africa