LAUSR

Purpose Many regulators offered new ways of working to help combat the COVID-19 pandemic, and the rolling review procedure is an important and successful example. In rolling reviews, data are submitted and reviewed as they become available before the full data package is available. This approach is resource intensive but faster than standard review processes and therefore of benefit to society and patients during a health emergency. In this study, we analyze the European Medicines Agency (EMA) rolling review process and extract learning, based on the vaccines and treatments that have been approved to date (November 2021), and formulate 3 suggestions for the future. Methods Data and information on rolling reviews and similar related processes were collected from health authority websites across the globe with a focus on the EMA. Literature searches in PubMed and checking company websites for additional information were conducted to complement and corroborate findings as required. Findings The duration of a rolling review cycle and the number of cycles before a conditional marketing authorization differ among different applications. Through the rolling review process, COVID-19 vaccines could be approved in record times, ranging from 17 to 36 days. The rolling review process is not limited to vaccines but is applied to promising treatments as well. Implications This study indicates that rolling reviews can be successfully conducted during a health emergency, such as the COVID-19 pandemic, to meet an unmet medical need. Other critical conditions or life-threatening diseases with unmet needs exist and may be suitable to be addressed by a rolling review process to accelerate patient access to life-changing treatments. Indeed, we call for an evaluation of the rolling review process, its use, and its efficiency to capture learning with the aim of building a new, lean, and effective expedited review procedure that could be institutionalized and added to the regulatory toolbox.