title: Regulatory In Vitro Diagnostics Landscape in Africa: Update on Regional Activities.
abstract: Improved diagnostic tests for tuberculosis case detection are urgently needed that are affordable, robust, and easy to use so that they can be implemented widely. The mandate of national regulatory authorities is to ensure the safety and effectiveness of diagnostics, protecting the population against unsafe products while expediting access to beneficial new devices. However, regulatory approval processes in the developing world are often complex, lengthy, and not transparent. Recent progress in building regulatory capacity using harmonized approaches will reduce duplication in clinical performance studies and manufacturing audits, facilitate information sharing through trust and mutual confidence building, and ultimately improve efficiency. These savings can be passed onto the consumers in the form of more affordable pricing and allowing new high-quality tests for tuberculosis to be introduced more quickly and without delay.
authors.affiliation: Department of Clinical Research, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, United Kingdom.
authors.forename: Ruth
authors.initials: R
authors.lastname: McNerney
authors.affiliation: Department of Clinical Research, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, United Kingdom.
authors.forename: Rosanna W
authors.initials: RW
authors.lastname: Peeling
mesh_terms: D000349:Africa; D057069:Diagnostic Test Approval / Q000331:legislation & jurisprudence* / Q000592:standards; D006801:Humans; D011933:Reagent Kits, Diagnostic; D014376:Tuberculosis / Q000175:diagnosis*; D014944:World Health Organization
chemical_list: D011933:Reagent Kits, Diagnostic
keywords: diagnostic tests; harmonization; regulation; tuberculosis