A high-level delegation from the Ghana Food and Drugs Authority (FDA) is on an official visit to Botswana Medicines Regulatory Authority (BoMRA) to assess BoMRA’s regulatory systems, facilitate discussions on improvement areas, and lay the groundwork for a detailed collaboration plan between the Ghana FDA and BoMRA. This visit is part of ongoing efforts to strengthen regulatory frameworks and support the achievement of WHO Maturity Level 3 status for BoMRA, under the Grand Challenges Project supported by the Gates Foundation. BoMRA and the Ghana (FDA) have a standing Memorandum of Understanding (MoU) that formalizes their ongoing collaboration in the regulation of medicines. This MoU ensures continued cooperation in enhancing the safety, efficacy, and regulatory oversight of medicines.
The primary goal of the visit is to assess BoMRA’s regulatory systems, facilitate discussions on improvement areas, and foster a detailed collaboration plan between Ghana FDA and BoMRA. Through structured meetings, Ghana FDA and BoMRA will identify areas of improvement across Market Authorization (MA), Pharmacovigilance (PV), Clinical Trials (CT), data system harmonization, and Monitoring and Evaluation (M&E), while also defining joint actions to enhance these systems.
Regulatory System Assessment: The Ghana FDA team will conduct a comprehensive review of BoMRA’s regulatory systems, evaluating existing procedures, infrastructure, and capacity to manage and oversee pharmaceutical products in line with international standards.
Facilitating dialogue and Knowledge Sharing: Both organizations will engage in detailed discussions to highlight improvement areas within BoMRA’s regulatory framework. Key focus areas include enhancing technical expertise, improving regulatory efficiency, and developing better public health safety protocols.
Collaboration and Action Plan: The visit will conclude with the drafting of a collaborative action plan aimed at streamlining both BoMRA and the Ghana FDA’s efforts towards improving regulatory systems. This will involve joint training, shared resources, and exchange of technical knowledge, facilitating the journey toward achieving WHO Maturity Level 3 status.
Dr. Seima Dijeng, CEO of BoMRA, highlighted the significance of the visit, stating, “This collaboration represents a critical step towards aligning our regulatory framework with global standards. The support and insights provided by the Ghana FDA which has advanced significantly in the area of pharmaceutical regulation are invaluable as we work towards our own strategic goal of achieving a fully functional stable and integrated regulatory system for Botswana. I am confident that through this collaboration between our two agencies, we can contribute towards the establishment of data systems to enhance and track regulatory process performance”
The delegation from the Ghana FDA, expressed optimism about the partnership, stating, “This visit underscores the importance of regional collaboration in strengthening regulatory systems. By sharing expertise and working together, we are ensuring that both Ghana FDA and BoMRA will be better equipped to meet international standards and protect public health. Achieving WHO Maturity Level 3 will not only improve the regulatory landscape but will also contribute to the broader goal of improving access to quality medicines across Africa.”
The Ghana FDA’s visit to BoMRA is a testament to the growing regional cooperation in Africa’s pharmaceutical regulatory landscape. The Grand Challenge Project’s focus on achieving WHO Maturity Level 3 status for BoMRA and marks a significant step forward in the continued strengthening of regulatory systems to improve public health outcomes across the region, and the Continent.
