It has become clear that agencies have a number of pathways that can be used during public health emergencies for the authorisation of therapeutics and vaccines. Some of these so-called Emergency Use Pathways (EUPs) have been in place and are broadly applicable to making vaccines and other therapies available during a time of crisis, while others have been newly designed specifically in response to COVID-19.
Because some of these are less well understood by the broader scientific community, we felt that it would be helpful to provide a high-level overview to illustrate the numbers and basic characteristics of EUPs used by several key agencies.
The goal of this R&D Briefing is to illustrate, with regard to authorisation, that many EUPs are available and that regulatory flexibility is one of the most important considerations for addressing critical, unique needs.
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