Introduction: When implemented by national and regional regulatory agencies
good review practices (GRevPs) support the timely high-quality review of
medicines for enhanced patients’ availability to safe, quality and efficacious
innovative and generic products. It is important that all aspects of GRevPs are
continuously evaluated and updated to promote the continuous improvement
of regulatory systems at national and regional levels. The aim of this study was to assess and compare the GRevPs of the national medicines regulatory agencies
(NMRAs) of Burkina Faso, Cote d’Ivoire, Ghana, Nigeria, Senegal, Sierra Leone
and Togo, who are active participants of the ECOWASMRH initiative to identify
opportunities for improvement.
Methods: The Optimising Efficiencies in Regulatory Agencies questionnaire, was
completed by each of the NMRAs, which facilitates the assessment of GRevPs,
which in turn affect the regulatory review processes.
Results: Except for Cote d’Ivoire and Nigeria which are autonomous, the other
five NMRAs operate within the administrative structure of their respective
Health Ministry, to regulate medical products for human use, medical devices
and diagnostics. Apart from Togo, the agencies receive partial funding from
their governments as well as from regulatory fees. Population in the seven
countries ranges from 8.6 million to 211.4 million. All the NMRAs had measures
in place to achieve quality in their review processes, although there were some
remaining initiatives related to transparency and communication, continuous improvement and training and education, to be implemented. Of the ten quality
decision-making practices Ghana had implemented nine into a framework,
Togo eight, Cote d’Ivoire seven, Nigeria six, and Burkina Faso five; while Sierra
Leone has partially implemented all ten and Senegal had not implemented any
of the quality decision-making practices.
Conclusion: The study compared the organisation, GRevPs and quality decisionmaking
processes
of
the
NMRAs
that
actively
participate
in
the
ECOWAS-MRH

initiative.
Though some differences
were
identified with regard
to organisation,

a
significant number of
good review
practice initiatives
and quality decisionmaking
practices were
identified yet to be implemented
to promote
continuous
improvement
in the regulatory
processes
of
the NMRAs.

Economic Community of West African States Medicines Regulatory Harmonisation (ECOWAS-MRH), good review practices, African Medicines Agency (AMA), regulatory reliance, Optimising Efficiencies in Regulatory Agencies (OpERA)