Regulatory Performance of African National Medicines Regulatory Authorities Achieving WHO Maturity Level 3:...

The World Health Organization (WHO) developed the WHO Global Benchmarking Tool (GBT) to assess and benchmark the drug regulatory systems and practices in national medicines regulatory authorities (NMRAs). The objective of the study was to identify strengths and opportunities for improvement by comparing the regulatory performance of the NMRAs in Egypt, Ghana, Nigeria, South Africa, Tanzania and Zimbabwe, all which have attained maturity level 3 status for medicines and /or vaccines, in order to enhance regulatory review processes and patients' access to medicines and/or vaccines.

The NMRAs selected for the study completed a questionnaire that collected data and metrics that facilitated comparative studies among the NMRAs.

The comparative study showed that similarities among these authorities also translated into their strengths. The study revealed that the human resource capacity in African NMRAs is inadequate to fully execute regulatory mandates. Review process map comparison revealed the important observation that these NMRAs conducted labelling review early in the review process rather than in the latter stages of the process.

The study has identified the regulatory best practices that led to the NMRAs achieving WHO GBT maturity level 3. The African Medicines Agency should engage these maturity level-3 NMRAs to explore ways of benefiting from their experience and resources. It is hoped that through such engagement, the NMRAs will be encouraged to further develop their capacity to help the AMA to achieve its mandate. Additionally, by addressing the identified gaps and recommendations in the study these NMRAs can achieve WHO GBT maturity level 4 whilst NMRAs who have not yet reached GBT maturity level 3 can also benefit from this study in order to reach higher maturity levels.