African Regulatory Systems Research
A study, commissioned by the Drugs for Neglected Diseases initiative, to develop a better understanding of how African authorities can regulate the safety, efficacy and availability of imported and local drugs and vaccines in ways that better reflect African realities, health environment and priorities.
At present, there is a quasi-global standard for securing regulatory approval for pharmaceuticals and related products, with developed country regulatory authorities seen as setting the benchmark. The emphasis on Western regulatory approaches has made it difficult for developing country regulators to appropriately assess and manage products for national use, and has led to slow approvals and other inefficiencies. The George Institute has been commissioned to develop an understanding of the various avenues through which product regulatory approvals are being handled in Africa and how they might be handled in a way that better reflects African realities, health environment and priorities.
Through interviews and desk research, the George Institute will review the regulatory models, approval mechanisms and surrogate mechanisms currently used in product regulation. The project will investigate how Northern regulatory approaches and mechanisms are used in and impact the South. These regulatory models will be appraised against criteria for drug registration and the appropriateness of the process for the African context. The project includes empirical analysis of the outcomes of approval and surrogate mechanisms such as WHO/EMEA Article 58, WHO pre-qualification and Orphan Drug mechanisms to assess their effectiveness in addressing regulatory needs of African countries.