Regulatory Convergence for Medical Devices in East/Central Africa

Regulatory Convergence for Medical Devices in East/Central Africa

Countries in Africa that are currently regulating medical devices have generally been regulating medical devices through agencies originally set up to regulate the pharmaceutical industry.  These agencies continue to function with design, staffing, and orientation to best suit the pharmaceutical industry. Distinguishing between medical devices and pharmaceuticals regulations is crucial due to the inherent differences […]

Regulatory Convergence for Pharmaceuticals in East/Central Africa

Regulatory Convergence for Pharmaceuticals in East/Central Africa

Convergence of regulatory requirements has many benefits, such as ensuring favorable marketing conditions to support early access to medicinal products, promoting competition and efficiency, and reducing unnecessary duplication of clinical testing. Achieving convergence of pharmaceutical regulations in Africa would also assist continental efforts for the control of a growing cross-border market of substandard and falsified […]