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S104: Comparison of the Regulatory Performance of NMRAs in Africa with WHO Maturity Level-3 Status: Identifying Best Practices

Poster Presenter

Mercy Acquaye Owusu-Asante

Graduate Student, School of Life and Medical Sciences
University of Hertfordshire
United Kingdom

Objectives

To identify best practices/opportunities for improvement by comparing the regulatory performance of the Egyptian Drug Authority, FDA Ghana, Nigeria FDA, South African Health Products Regulatory Authority and Tanzania Medicines and Medical Devices Authority, to enhance patients’ access to medicines.

Method

The five maturity level-3 (ML3) NMRAs completed the established standardized OpERA questionnaire. The collected data on timelines and other metrics was analysed to compare the regulatory strengths of the participating NMRAs and identify similarities and differences as they strive to achieve ML4.

Results

The agencies except for FDA Ghana, are autonomous to regulate medical products for human and veterinary use, medical devices and diagnostics. The scope of regulatory activities includes; marketing authorizations/ product licenses, clinical authorization, post-marketing surveillance, regulation of advertising, laboratory analysis of samples and regulatory site inspections/visits. The study also revealed that the human resource capacity in the participating African NMRAs is inadequate to execute the totality of their regulatory mandate. The agencies reported that they employ the three types of review models: type 1 (verification), type 2 (abridged) and type 3 (full) for the scientific assessment of medicines; while Tanzania and Nigeria only utilise full and abridged review models for all applications. All the five agencies have in place a priority/fast-track procedure for applications relating to diseases with unmet medical need. The agencies set targets for the time spent for review and approval and there are similar key milestones in the review process among the agencies. A dossier in the common technical document (CTD) format with all the five modules is required for all types of scientific assessments in all the agencies. The overall approval time for a full review of a generic ranged from 120 to 576 calendar days while the approval time for a full review of a NAS ranged from 42 to 855 calendar days. A striking difference which was observed on comparing the review process maps was that whilst the NMRAs conduct labelling review early in the process, the WHO prequalification of medicines programme conducts labelling review at the end of the review process, prior to authorization of the application, in order to facilitate the preparation of public assessment reports. It was noted that the agencies have implemented almost all the quality measures related to good review practices and Quality Decision-Making Practices.

Conclusion

The African Medicines Agency (AMA), where operationalization is imminent, will be depending on the contribution of the NMRAs, in particular those of the WHO ML3 status. Through such engagement, they will build on their strengths, address identified gaps as they learn from best practices. The recommendations from this study could help the five agencies as they move forward to realise their ambition of achieving ML4. Furthermore, other NMRAs who have not yet reached maturity level-3 can also benefit from this study as they embark on their journey to reach higher maturity levels. Recommendations 1.Collaboration: There should be collaboration amongst the NMRAs that have achieved WHO GBT maturity level-3 status with establishing an expert working group consisting of assessors from these NMRAs that can apply their relatively stringent standards in the assessment of NASs. In addition, through an innovative collaborative procedure, the outcome of the assessment could be applied throughout the African continent. This will enhance patients’ access to much-needed NASs in Africa. 2.Mutual Recognition: A mutual recognition procedure should be established such that duplication in assessments is significantly reduced whilst resources are used more efficiently. 3.African Medicines Agency; This recently established organisation should engage these maturity level-3 NMRAs to explore ways that the AMA could benefit from their experience and resources. This will ensure that the AMA is effective and efficient in achieving its overall goal. 4. Regulatory review process: The NMRAs in Africa should review the timing of their product labelling so that it is conducted at the end of the review process but prior to the authorization of the application in order to facilitate the preparation of public assessment reports. 5.Quality Decision-Making Practices: Agencies should have in place a formal assessment to periodically measure the quality of their decision-making processes