Regulatory In Vitro Diagnostics Landscape in Africa: Update on Regional Activities

Clin Infect Dis. 2015 Oct 15;61Suppl 3:S135-40. doi: 10.1093/cid/civ553.


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.

Keywords: diagnostic tests; harmonization; regulation; tuberculosis.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Africa
  • Diagnostic Test Approval / legislation & jurisprudence*
  • Diagnostic Test Approval / standards
  • Humans
  • Reagent Kits, Diagnostic
  • Tuberculosis / diagnosis*
  • World Health Organization


  • Reagent Kits, Diagnostic