Rolling Reviews During COVID-19: The European Union Experience in a Global Context

Abstract

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.

Keywords: COVID-19; dynamic regulatory assessment; expedited approval pathways; pandemic; rolling review; vaccines.

Figure 1

Pictogram showing the health authorities around the globe that introduced or offered a rolling review process to applicants for the evaluation of COVID-19 treatments and vaccines. ANVISA = Brazilian Agencia Nacional de Vigilancia Sanitaria; EMA = European Medicines Agency; FDA = US Food and Drug Administration; HAS = Health Science Authority; MHRA = UK Medicines and Healthcare Products Regulatory Agency; NMPA = Chinese National Medical Products Administration; PMDA = Pharmaceuticals and Medical Devices Agency; WHO = World Health Organization.

Figure 2

The number of rolling review cycles used for the vaccines that have been approved by the European Medicines Agency to date (November 2021).

Figure 3

Number of cycles, days per rolling review (RR) cycle, and timelines of the conditional marketing authorization (CMA) review for the vaccines that have been approved by the European Medicines Agency to date (November 2021).

Figure 4

Infographic on the rolling review steps and associated timelines of the nonvaccine treatment remdesivir line extension. CHMP = Committee for Medicinal Products for Human Use.