Regulatory Systems Strengthening for Medicines in Africa: Shining a Spotlight on the World Bank Group’s Decade-Long Contributions (Brief)

The document is a knowledge brief from the Health, Nutrition and Population Global Practice, dated August 2022. It highlights the World Bank Group's (WBG) commitment over the past decade to assist African nations in enhancing their medicines regulations, governance, and accountability within their healthcare systems. The primary objective has been to bolster the medicines regulatory environment, ensuring increased access to safe, efficacious, and high-quality medicines. The document underscores the establishment of the African Medicines Regulatory Harmonization (AMRH) initiative in 2009, which aimed to improve fragmented regulatory systems in Africa. With funding from the Bill and Melinda Gates Foundation, the WBG set up a trust fund in 2011 to support the AMRH initiative. Since its inception, there have been significant advancements, including reduced timelines for medicine registration, harmonized registration systems, and an increased emphasis on quality management and transparency. The COVID-19 pandemic further highlighted the importance of well-established regulatory systems. The document also discusses the forthcoming African Medicines Agency, which represents the next phase in the AMRH initiative, aiming to institutionalize the regulatory system's strengthening efforts.