Reliance for Emergency Use Authorization of Medicines and Other Health Technologies in a Pandemic (e.g. COVID-19)

Abstract

Purpose and Context: This document provides guidance to national regulatory authorities (NRAs) and regulatory systems on practical ways to implement reliance for emergency use of medicines and other health technologies in and around a pandemic. Note that countries use different terminologies for emergency use and the Pan American Health Organization (PAHO) will use the term “Emergency Use Authorization” (EUA). For the purposes of this document, medicines and other health technologies are defined to include pharmaceuticals, vaccines, and in Vitro Diagnostics (IVDs). Countries are encouraged to develop plans for regulatory preparedness and response in a pandemic including related to EUA of medicines and health technologies. This will afford an orderly and legal process to expedite the incorporation of these products into health systems. According to WHO guidance(1), country regulatory frameworks should include laws and/or policies that permit EUA for medicines and other health technologies, a pandemic preparedness plan that acknowledges EUA, technical procedures that use reliance and recognition on trusted/reference authorities for the EUA, and a system to monitor EUA products in the market. This document focuses on technical procedures for reliance to issue an EUA.