Regulators around the globe have reviewed marketing authorisation applications (MAAs) for COVID-19 vaccines and treatments at record speed. One of the tools they used to speed the review cycle is the use of so-called
rolling reviews or rolling applications.
With rolling reviews, data are submitted and reviewed as they become available instead of waiting for the full data package – nonclinical, clinical and quality – to be available and submitted at the same time. By being able to review data as they become available, regulators can assess and request additional information and clarifications quicker than in a traditional review pathway.
Open Orphan (LON:ORPH) was founded in 2017, with the goal of rapidly building Europe’s leading pharma services company by a management team with extensive industry and financial expertise. The company comprises of two commercial specialist CRO services businesses (Venn Life Sciences and hVIVO) and is also developing a genomics data platform business (Genomic Health Data).