Clinical Pharmacology & Therapeutics
Volume 108, Issue 4 Pages: 681-895 October 2020
Pandemic Best Regulatory Practices: An Urgent Need in the COVID‐19 Pandemic
Murray M. Lumpkin, John C. W. Lim
First Published:04 June 2020
As large numbers of candidate drugs and vaccines for potential use in the coronavirus disease 2019 (COVID‐19) pandemic are being investigated, medicine regulators globally must now make urgent, informed, contextually risk‐1based decisions regarding clinical trials and marketing authorizations. They must do this with the flexibility demanded by the pandemic while maintaining their core risk assessment and public safety functions. We lay out the critical role of regulators in the current crisis and offer eight “pandemic best regulatory practices.” These should support both the regulatory public heath imperative and assure timely patient access to effective, safe, quality products worldwide during this emergency—thus contributing to ending this pandemic as quickly, effectively, and safely as possible.