ArticleClinical therapeutics2022
Rolling Reviews During COVID-19: The European Union Experience in a Global Context.
Article in Clinical therapeutics, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
17 citing papers in PubMed.
- Contribution of Real-World Evidence for the Orphan Medicines Approvals in the European Union Between 2000 and 2025.Therapeutic innovation & regulatory science · 2026Article
- How Can Pharmacology Help Us Overcome the Challenges of Drug Repositioning as Antivirals to Treat Emerging Pathogens? The Example of Covid-19.Clinical and translational science · 2026Review
- Article
- Future-Proofing European Pharmaceutical Regulatory and Market Access Practices Based on EU Learnings from the COVID-19 Pandemic: Insights from Multi-Stakeholder Interviews.Therapeutic innovation & regulatory science · 2026Article
- Drug Repurposing for Inclusion of COVID-19-Related Indication: Field Study of the European Medicines Agency's Response to the Pandemic.Pharmacy (Basel, Switzerland) · 2025Article
- A Fast Path from Innovation to Safe and Effective Medicines.Clinical pharmacology and therapeutics · 2025Review
- Review
- Accelerating the approval of mpox vaccines based on lessons learnt from COVID-19 vaccines through the lens of regulatory science.BMJ global health · 2025Review
- Safety and reactogenicity of the BNT162b2 COVID-19 vaccine: Development, post-marketing surveillance, and real-world data.Human vaccines & immunotherapeutics · 2024Review
- Review
- mRNA: Vaccine or Gene Therapy? The Safety Regulatory Issues.International journal of molecular sciences · 2023Review
- Factors, enablers and challenges for COVID-19 vaccine development.BMJ global health · 2023Review
- Regulatory approval pathway for COVID-19 vaccine in USA, Europe and India.Annals of medicine and surgery (2012) · 2023Article
- Are psychological status and trust in information related to vaccine hesitancy during COVID-19 pandemic? A latent class and mediation analyses in Italy.Human vaccines & immunotherapeutics · 2022Article
- Future directions in regulatory affairs.Frontiers in medicine · 2022Review
- [Allocation of single-use drugs in children in global compassionate use programs].Ethik in der Medizin : Organ der Akademie fur Ethik in der Medizin · 2022Article
- Vaccines for neglected tropical diseases: Learnings from COVID-19.The Indian journal of medical researchArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeMany 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.
methodsData 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.
findingsThe 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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.