Enhancing Data Systems of African National Regulatory Agencies - Botswana

The Botswana Medicines Regulatory Authority in Botswana will support national regulatory processes by enhancing the data systems with a package of improvements. The project is a collaboration with the Ghana Food and Drugs Authority. They will bolster processes across both agencies by deploying a standardized set of metrics and key performance indicators. This will include finalizing the implementation of integrated regulatory information management systems. These systems will be harmonized so that the two agencies can share reports following data capture and analysis. The collaboration will include strengthening multiple regulatory functions in Botswana, including strengthening pharmacovigilance by incorporating procedures for monitoring activities for risk minimization and risk communication. It will also include strengthening clinical trial regulation by enhancing management of the review process from receipt of applications to post-approval compliance to final reporting.