July 13, 2023

Health Regulatory Issues - 2023 U.S.-Africa Business Summit

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PATH’s Sibusiso Hlatjwako moderated an engaging panel on "Health Regulatory Issues" on Thursday, July 13, which summarized important future directions in terms of greater private sector collaboration with regulators coming out of the Pandemic. There was a sense throughout the discussion that Africa has a significant opportunity to increase access to innovative and new medicines through greater harmonization of rules and regulations across the Continent as well as through increased collaboration with the private sector. United States Pharmacopeia’s Neimatu Adjabui noted the importance of building more trust within African national regulatory authorities regarding working with the private sector, while also working to address language barriers and addressing regulatory agencies’ concerns that harmonization could reduce the amount of revenue NRAs can generate. In addition, she noted that the following would be important focus areas: information management tools, addressing language barriers across countries and ensuring sustainable financing of National Medicines Regulatory Authorities (NMRAs). GE Healthcare’s George Uduku noted that companies can ameliorate some of these concerns by offering technical support and assistance, as well as sharing more data and being more transparent about company processes. Abbott’s Shireen Haroon agreed on the importance of accelerating harmonization, including for diagnostics and devices, and Ropafadzai Hove, the Chief Regulatory Officer for Botswana Medicines Regulatory Authority, cited Botswana’s experience as a model for other NRAs, particularly in meeting global standards. She also shared that the SADC region has conducted a feasibility study on regulating medical devices, which noted legislative gaps and allows the SADC region to map a way forward for countries in the region to regulate medical devices. Heather Lanigan, the Regional Director for Sub-Saharan Africa at the U.S. Trade and Development Agency, also described USTDA’s program to support priority infrastructure projects in emerging markets.Click hereto watch the recorded session.