Abstract
Margareth Ndomondo-Sigonda outlines future challenges for the East African Medicines Regulatory Harmonization initiative.
Highlights
The combination of artesunate with amodiaquine is widely used to treat malaria in sub-Saharan Africa
These reports, collected by the World Health Organization (WHO)’s global Individual Case Safety Report VigiBase database, hosted and managed by Sweden’s Uppsala Monitoring Centre, along with data gathered by the manufacturer, resulted in a new labeling and package insert for the medicine combination that warned of the potential for acute extrapyramidal reactions [2]. (Drug-induced extrapyramidal side effects are movement disorders with acute and long-term symptoms, including dystonia, akathisia, parkinsonism, bradykinesia, tremor, and tardive dyskinesia.) Without the help of the eight sub-Saharan African countries that submitted reports to VigiBase, it is unclear whether the association between the medicine combination and this adverse event would have been detected
The improved capacity of all national medicines regulatory authorities (NMRAs) to engage in critical regulatory activities
Summary
The East African Community (EAC)’s Medicines Regulatory Harmonization (MRH) initiative was created to improve access to quality, safe medicines in the region by simplifying the regulatory process while maintaining a high level of rigor. In the future, other key success factors for the initiative will include establishing a cadre of regional technical officers (RTOs), a Cooperation Framework Agreement between the national medicines regulatory authorities (NMRAs) of EAC Partner States, and a sustainable funding mechanism for regional assessment. Practice; IMS, information management system; IVD, in vitro diagnostic; MRH, Medicines Regulatory Harmonization; NMRA, national medicines regulatory authority; PAHWP, Pan African Harmonisation Working Party on Medical Devices and Diagnostics; PIC/S, Pharmaceutical Inspection Cooperation Scheme; RTO, regional technical officer; SOP, standard operating procedure; Swissmedic, Swiss Agency for Therapeutic Products; WHO, World Health Organization.
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