Practical Guidance for the Development of National Essential Diagnostics Lists

This guide is intended to provide countries in Africa with guidance around developing a national essential diagnostics list (NEDL) or revising their harmonisation documents on in vitro diagnostics (IVDs). The guide is intended as a companion to the World Health Organization’s (WHO’s) publication ‘Selection of Essential In Vitro Diagnostics at Country Level’, to provide practical guidance to African countries on developing an NEDL. The advice and tools provided within the guide will help countries develop NEDLs that are appropriate for their settings and aligned with universal health coverage goals and priorities for the continent as set out by the Africa Centres for Disease Control and Prevention (Africa CDC). Recognising that countries will differ in the extent of their existing formal guidance around IVDs, this document provides guidance for developing, updating and revising NEDLs as required. This guide is intended for ministries of health, particularly those involved in IVD guidelines, policy- and decision-makers, and other stakeholders involved in developing guidelines around IVDs at the state and national level.