rollingreview

Rollingreview is a term used in regulatory science to describe a data assessment approach in which evidence is reviewed and evaluated as it becomes available, rather than after a complete, finalized dataset is submitted. The aim is to shorten the time from data readiness to final decision by allowing parallel processing of evidentiary modules and early communication of findings.

Usage and context: Rolling reviews have been employed by regulatory authorities during public health emergencies to expedite access to medicines, vaccines, and therapies. The European Medicines Agency (EMA) used rolling reviews during the COVID-19 pandemic to assess data in stages—clinical results, manufacturing information, and other modules—before granting full marketing authorization. Other agencies have applied similar approaches for urgent products, adapting the process to local regulatory frameworks.

Process: A rolling review typically involves early engagement between sponsors and the regulator, an agreed plan for data submission, and iterative assessment of individual modules as they become available. As data accumulate, the regulator updates its preliminary positions. Once the complete data package is available, a final evaluation is conducted, followed by a formal decision or recommendation and, if applicable, labeling and risk management considerations.

Advantages and challenges: Benefits include reduced time to authorization and earlier patient access, better planning, and earlier identification of data gaps. Challenges include maintaining rigorous standards with partial data, ensuring transparency and clear communication of uncertainties, and managing the ongoing resource demands of continuous assessment.

See also: emergency use authorization, rolling submission, regulatory science. Notes: The term is used generally and implementations vary by jurisdiction.