ADDIS ABABA, Oct. 24 (Xinhua) -- Industry experts and stakeholders on Friday called for concerted action to establish a robust ecosystem for bioequivalence testing to ensure locally manufactured generic medicines across Eastern and Southern Africa are safe, accessible, and scientifically proven.
The call was made during a regional workshop focused on developing a White Paper on bioequivalence testing and regulatory harmonization in Eastern and Southern Africa, held in Addis Ababa, the capital of Ethiopia. The five-day event, which ran from Oct. 19 to 23, highlighted the critical need for harmonized regulatory frameworks and expanded domestic testing capacity to eliminate costly reliance on overseas facilities.
Jointly organized by the Intergovernmental Authority on Development (IGAD), the Ethiopian government and the World Bank, the workshop brought together national regulators, pharmaceutical manufacturers, experts and researchers, as well as development partners to establish a comprehensive regional framework for bioequivalence testing.
Experts and policymakers at the gathering emphasized that relying on external testing facilities imposes significant economic burdens and causes regulatory approval delays for locally manufactured generic drugs. They stressed the urgent need to expand domestic testing capacity to support sustainable pharmaceutical growth across the region.
Addressing the workshop, Girum Hailu, a senior policy and partnership specialist at IGAD, highlighted several critical gaps affecting the sector, including limited regional bioequivalence testing facilities, heavy dependence on overseas testing, high study costs, and inconsistent regulatory requirements across borders.
To overcome these challenges, experts advocated for advancing regulatory harmonization aligned with international standards, implementing phased, risk-based compliance pathways for legacy products, and establishing shared regional testing capacity backed by strong oversight mechanisms to support local manufacturers.
Stakeholders also underscored the vital importance of making bioequivalence services more affordable and accessible to local pharmaceutical manufacturers, outlining priority investments and capacity-building measures for accredited centers across the region. ■