Knowledge Brief: Regulatory Systems Strengthening for Medicines in Africa: Augsut 2022
By A. Mercado, A. Seiter, K. Boateng and L. Philippe Kagan
Introduction
Ten years ago, the World Bank Group (WBG) committed its support to helping African countries strengthen their medicines regulations, governance, and accountability in the pharmaceutical sector of their health care systems.
Strengthening the medicines regulatory environment is a well-established prerequisite for increasing access to safe, efficacious, and good quality medicines, and for the successful development of a functioning pharmaceutical industry. While affordability remains the cornerstone of access (WHO 2020), other factors play a role in hindering access to quality medicines. In Africa, these barriers can be attributed, in part, to “weak or non-coherent regulatory standards and requirements among countries; lengthy medicine registration processes that lead to delays in approval decisions; technical capacity and capability; overall resource constraints; and failure to leverage regulatory review activities already performed by better-resourced regulatory authorities and the World Health Organization (WHO)” (Ndomondo-Sigonda et al. 2018).
At the WBG, ensuring that such barriers are removed so that every person can lead a healthy, productive life is central to our shared goals of ending poverty and boosting our shared prosperity. In 2011, to help make life-saving health products more accessible in poor countries, the WBG with generous funding from the Bill and Melinda Gates Foundation (BMGF), set up a trust fund to support the African Medicines Regulatory Harmonization (AMRH) initiative (Figure 1).
Blog » Knowledge Brief: Regulatory Systems Strengthening for Medicines in Africa: August 2022
Knowledge Brief: Regulatory Systems Strengthening for Medicines in Africa: August 2022
Knowledge Brief: Regulatory Systems Strengthening for Medicines in Africa: Augsut 2022
By A. Mercado, A. Seiter, K. Boateng and L. Philippe Kagan
Introduction
Ten years ago, the World Bank Group (WBG) committed its support to helping African countries strengthen their medicines regulations, governance, and accountability in the pharmaceutical sector of their health care systems.
Strengthening the medicines regulatory environment is a well-established prerequisite for increasing access to safe, efficacious, and good quality medicines, and for the successful development of a functioning pharmaceutical industry. While affordability remains the cornerstone of access (WHO 2020), other factors play a role in hindering access to quality medicines. In Africa, these barriers can be attributed, in part, to “weak or non-coherent regulatory standards and requirements among countries; lengthy medicine registration processes that lead to delays in approval decisions; technical capacity and capability; overall resource constraints; and failure to leverage regulatory review activities already performed by better-resourced regulatory authorities and the World Health Organization (WHO)” (Ndomondo-Sigonda et al. 2018).
At the WBG, ensuring that such barriers are removed so that every person can lead a healthy, productive life is central to our shared goals of ending poverty and boosting our shared prosperity. In 2011, to help make life-saving health products more accessible in poor countries, the WBG with generous funding from the Bill and Melinda Gates Foundation (BMGF), set up a trust fund to support the African Medicines Regulatory Harmonization (AMRH) initiative (Figure 1).
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