Assessment of Medicines Regulatory Systems in Sub-Saharan African Countries. An Overview of Findings from 26 Assessment Reports
(2010; 48 pages)


Medicines regulation is needed to ensure that all pharmaceutical products on the market are safe, effective and consistently meet approved quality standards. WHO works with Member States in assessing national regulatory systems to identify gaps, develop strategies for improvement and support countries in their commitment to build national regulatory capacity. This report synthesizes the findings of rapid assessments performed at national medicines regulatory authorities (NMRAs) in 26 African countries over the last eight years. It is mainly based on the reports provided to the countries by the assessment teams. Although the emphasis of the missions was on capacity-building rather than a standardized comparison of indicators, the findings are thought to give a reasonable overview of the regulatory situation in Africa at the time of the visits...Structures for medicines regulation existed in the countries assessed, and the main regulatory functions were addressed, although in practice the measures were often inadequate and did not form a coherent regulatory system. Common weaknesses included a fragmented legal basis in need of consolidation, weak management structures and processes, and a severe lack of staff and resources. On the whole, countries did not have the capacity to control the quality, safety and efficacy of the medicines circulating on their markets or passing through their territories. Regulatory capacity should be built urgently in African countries, using the following approaches:

  • Encourage and assist countries to assess their own regulatory systems in a systematic way in order to identify and address gaps.
  • Work towards consistent implementation of all essential regulatory functions in African countries, based on the key provisions in the existing legal frameworks.
  • Strengthen management structures, specific technical regulatory expertise and physical resources (both human and financial) available to NMRAs in Africa.
  • Consider mechanisms for sharing the outcomes of regulatory assessments.
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