Reflection paper on lessons learned from the COVID-19 pandemic: Scientific considerations on non-clinical aspects
Human
Scientific guidelines
This reflection paper covers SARS-CoV-2 vaccines and medicinal products intended to prevent or treat COVID-19 and its complications. It focuses on the non-clinical scientific considerations for pivotal, non-clinical data used to support clinical development, marketing authorisation and patient safety in the pandemic setting. Procedural regulatory aspects are not in scope of this document. The paper identifies a number of learnings from the Covid-19 pandemic which can be considered in order to facilitate efficient and rapid non-clinical development and safety assessment in the future.
Keywords: Non-clinical, safety, efficacy, in vivo, in vitro, drug regulation, COVID-19, drug repurposing, vaccines, platform technology, regulatory science