Awards

Issiaka Soulama of the Agence Nationale de Régulation Pharmaceutique (ANRP) in Burkina Faso will support national regulatory processes by enhancing the data systems with a package of improvements. The project is a collaboration with the Food and Drugs Authority in Ghana. They will implement training programs for staff to enhance the technical evaluation of marketing authorization applications and clinical trial protocols. For all pharmaceutical regulatory functions, they will define a framework for developing key performance indicators as well as develop and implement standard operating procedures for the production, collection, analysis, and dissemination of key statistics. They will also implement a digital and integrated information management system to support standardizing the regulatory data and connecting the relevant databases.

The National Drug Authority in Uganda will support national regulatory processes by enhancing the data systems with components that monitor key performance indicators. The project is a collaboration with the Uganda National Council for Science and Technology and with the Tanzania Medicines and Medical Devices Authority, who will help ensure that systems of both partners are interoperable across regulatory functions covering clinical trials, market authorization, and good manufacturing practices. They will design and then incorporate monitoring and evaluation modules into the regulatory information management system. The modules will track key performance indicators of the system, generating real-time reports as well as quarterly and annual reports on performance trends. This monitoring will facilitate evidence-based improvements in the process. It will also facilitate integration with other systems within the National Drug Authority, including a harmonized approach to data standardization.

The Food and Drugs Authority in Ghana will support national regulatory processes by enhancing the data systems with a package of improvements. The project is a collaboration with the Botswana Medicines Regulatory 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. They will also share analytics tools and methodologies for deriving insights from data, including predictive modeling, trend analysis, as well as real-time monitoring to proactively address challenges that arise for the data systems.

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.