Regulatory Cooperation in Vaccines in Asia-Pacific Region

Simon Lacey (University of Adelaide), Andrew D. Mitchell (Monash University), Regulatory Cooperation in Vaccines in Asia-Pacific Region (2022):

This paper explores the massive strides that were made in response to the COVID-19 pandemic by national drug regulatory agencies (NRAs) in order to achieve what ultimately became the fastest incidence in human history of the development, testing, approval, manufacture, and distribution of a new vaccine to an infectious respiratory disease that at the time of writing (April 2022) has by some estimates claimed over 6 million human lives. Our purpose in writing this paper is to highlight what regulators did right, where the pandemic shone a light on gaps, and what can be done by national governments to increase readiness in their NRAs for the next time they are called upon to execute their role in a similar herculean effort.