Has COVID-19 revolutionized the future of regulation of medicine development and authorization or are we simply responding to an unprecedented global pandemic? Our Head of Regulatory Affairs and Enhanced Services, Harriet Edwards, delves deep on how the pandemic changed the industry we work in today.
COVID-19, or SARS-CoV-2, has undoubtedly changed the world as we know it, affecting daily life, health, and economics to an unprecedented degree. Due to the widespread and devastating impact of this previously unknown virus, there has been a massive effort from the pharmaceutical industry to rapidly develop a vaccine to protect the population. As a consequence of the increasingly evolving threat of COVID-19, developers and regulators have had to respond accordingly, learning about the virus while attempting to develop and regulate treatments concurrently
This article aims to examine whether COVID-19 (SARS-CoV-2) has changed the future of regulation through identifying and discussing the notable regulatory milestones achieved over the course of the COVID-19 pandemic (to date), and critically analyzing the regulation of those successful vaccine candidates that have been authorized at the time of writing, while posing the ultimate question; has COVID-19 revolutionized the future of regulation of medicine development and authorization or are we simply responding to an unprecedented global pandemic?