Assessment of medicines regulatory systems in sub-Saharan African countries (Report)

This report provides an overview of findings from assessments conducted in 26 African nations by the World Health Organization (WHO). They emphasize the importance of medicines regulation to ensure the safety, efficacy, and quality of pharmaceutical products available to the public. The report acknowledges the challenges posed by the increasing globalization of commerce, the emergence of pharmaceutical companies, and the presence of substandard and counterfeit pharmaceutical products, especially in developing countries.

The assessments revealed that while structures for medicines regulation existed in the countries evaluated, the measures were often inadequate and did not form a coherent regulatory system. Common weaknesses identified included a fragmented legal basis, weak management structures, and a severe lack of staff and resources. As a result, many countries did not have the capacity to control the quality, safety, and efficacy of the medicines circulating in their markets.

The report suggests several approaches to address these challenges:

Encourage countries to assess their regulatory systems to identify and address gaps. Work towards consistent implementation of all essential regulatory functions. Strengthen management structures, technical regulatory expertise, and physical resources. Consider mechanisms for sharing the outcomes of regulatory assessments.

The document underscores the urgent need for regulatory capacity-building in African countries to ensure the safety and efficacy of medicines available to their populations.