We’ve previously described the unique diversity in population, pathogenic profile, environment and disease epidemiology as well as the experienced investigators and sites and local investment in growing the research capacity on the African continent. Another key consideration for clinical research is the regulatory environment for postmarketing activities of the investigational products. How difficult and time-consuming is it to have a new product approved for use in African countries?
Inefficient regulatory processes can limit the introduction of new medicines.
Successful regional harmonization has paved the way for expansion across the continent.
- African Union Commission (AUC)
- Pan-African Parliament (PAP)
- World Health Organization (WHO)
- Bill and Melinda Gates Foundation
- World Bank (WB)
- UK Department for International Development (DFID)
- US Government-PEPFAR
- Global Alliance for Vaccines and Immunization (GAVI)
Arab Maghreb Union (AMU)
Common Market for Eastern and Southern Africa (COMESA)
Community of Sahel-Saharan States (CEN-SAD)
East African Community (EAC)
Economic Community of Central African States (ECCAS)
Economic Community of West African States (ECOWAS)
Intergovernmental Authority on Development (IGAD)
Southern African Development Community (SADC)
Three key accomplishments have resulted from the cross-regional AMRH initiative.
AU Model Law
It’s time to consider Africa as a clinical trials destination.
- Narsai K, Williams A, Mantel-Teeuwisse AK. Impact of regulatory requirements on medicine registration in African countries – perceptions and experiences of pharmaceutical companies in South Africa. South Med Rev 2012;5(1):31-37. https://pubmed.ncbi.nlm.nih.gov/23093897/
- Health Research and Innovation Strategy for Africa (HRISA): 2018-2030. Africa Union Development Agency. Available at: https://www.nepad.org/publication/health-research-and-innovation-strategy-africa-hrisa-2018-2030
- African Medicines Regulatory Harmonisation (AMRH). African Union Development Agency. Available at: https://www.nepad.org/programme-details/998.
- African Union Model Law for Medical Products Regulation: Increasing access to and delivery of new health technologies for patients in need. United Nations Development Programme. Available at: https://adphealth.org/upload/resource/AU%20Model%20Law.pdf
- Agenda 2063: The Africa We Want. African Union. Available at: https://au.int/en/agenda2063/overview.
- Sustainable Development Goals. United Nations. Available at: https://sdgs.un.org/goals.
- Regional Economic Communities (RECs). African Union. https://au.int/en/organs/recs.
- Ncube BM, Dube A. Ward K. Establishment of the African Medicines Agency: progress, challenges and regulatory readiness. J of Pharm Policy and Pract 2021;14:29. https://doi.org/10.1186/s40545-020-00281-9
- Mashingia JH, Ahonkhai V, Aineplan N, Ambali A, Angole A, Arik M, et al. (2020) Eight years of the East African Community Medicines Regulatory Harmonization initiative: Implementation, progress, and lessons learned. PLoS Med 17(8): e1003134. https://doi.org/10.1371/journal.pmed.1003134
- Ahonkhai V, Martins SF, Portet A, et al. Speeding Access to Vaccines and Medicines in Low- and Middle-Income Countries: A Case for Change and a Framework for Optimized Product Market Authorization. PLoS ONE 2016;11(11): e0166515. https://doi.org/10.1371/journal.pone.0166515
- The Republic of Rwanda Signs the Treaty for the Establishment of the African Medicine Agency (AMA). African Union. June 12, 2019. Available at: https://au.int/en/pressreleases/20190612/republic-rwanda-signs-treaty-establishment-african-medicine-agency-ama
- Pincombe M, Guzman J. A Defining Moment for Medicines Regulation in Africa: The Establishment of the African Medicines Agency. Center for Global Development. February 3, 2022. Available at: https://www.cgdev.org/blog/defining-moment-medicines-regulation-africa-establishment-african-medicines-agency
- Adepoju P. South Africa’s Cabinet Approves African Medicines Agency Treaty. Health Policy Watch: Independent Global Health Reporting. October 11, 2022. Available at: https://healthpolicy-watch.news/south-africa-african-medicines-agency
- Byaruhanga J. The Pharmaceutical Manufacturing Plan for Africa. AUDA-NEPAD. August 24, 2020. Available at: https://www.nepad.org/news/pharmaceutical-manufacturing-plan-africa