Fragmented drug supply channel and absence of National Medicines Regulatory Authorities (NMRAs) in some African countries to guarantee quality, safety, and efficacy of drugs and medical products is hampering patients to essential medicines such as analgesics, antibacterials, antimalarials, anti-tuberculosis, etc. in the continent, including Nigeria.
This development has led to delays to some essential medicines due to long approval times for applications to register medicines with patients suffering needlessly as they cannot get critically needed treatment in time.
Dr. Paul Orhii, Director General of NAFDAC, called on the Heads of National Medicine Regulatory Authorities (NMRA) and West African Economic Monetary Union (WAEMU) to hasten the harmonisation of medicine regulation in West African region.
Dr. Orhii disclosed that the harmonisation will reduce duplication as it affects inspection activities and cut down cost initially incurred from sponsoring large number of inspectors by NMRAs to manufacturing companies, reduce burden on companies, increase capacity building and information sharing, while improving regulatory confidence among member states.
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“The benefits of the common guidelines and governance mechanism will see the sub-region, including Nigeria witness improved public health with rapid access to safe and efficacious medicine to treat priority diseases,” Dr. Orhii pointed out.
he harmonization streamlines the registration process for both regulators and manufacturers, leading to increased access for medicines.
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Recent findings from NEPAD African Medicines Regulatory Harmonisation (AMRH) study reveal that member states operate independently and each country has its own technical requirements and format for registration applications for drugs.
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While this development is a barrier for trade and market accessibility for medicines, the study called for member states to have common technical requirements and collaborate broadly such as sharing assessment and inspection reports, joint evaluations and inspections.
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The meeting of NMRA and WAEMU at Burkina Faso held recently was fashioned to promote the adoption of common set of standards, documentation and procedures for medicine regulation among member countries of ECOWAS comprising 15 countries.
