Session Date: April 24, 2021
Session Description: During a public health emergency — particularly related to a novel pathogen such as SARS-CoV-2– governments must move expeditiously to provide access to new medical products (e.g., tests, treatments, and vaccines) after considering their relative health benefits and risks, based on preliminary safety and efficacy data from clinical trials. National regulatory agencies (FDA-equivalents) can grant Emergency Use Authorization (EUA) in lieu of standard market approval to allow use of new products in an emergency with conditions in place to mitigate risk. EUAs balance speed with the need to safeguard public health. Further, even with EUA, regulators must review extensive and technically complex data. There are several ways to reduce the technical burden and duration of data review. This session will clarify the differences between EUA and standard market authorization and will detail the requirements for approving use of new medical products under EUA. It will describe how LMIC regulatory agencies can implement various WHO-endorsed approaches to improve regulatory efficiency (e.g., recognition and reliance). Recent examples of EUA of COVID-19 products in LMICs, highlighting Pakistan’s experience, will illustrate how these approaches can overcome the resource and expertise challenges faced by many LMIC regulatory authorities to yield timely, well-justified approvals guided by science and data.