ReviewClinical therapeutics2021
Regulatory Agilities in the Time of COVID-19: Overview, Trends, and Opportunities.
Review in Clinical therapeutics, 2021. 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.
- From trial site to research emerging research hub: mapping Ghana's vaccine research ecosystem, 1977-2025.Health research policy and systems · 2026Review
- Building a case for accelerated clinical development of drugs and vaccines - what are the driving forces?Globalization and health · 2026Article
- Article
- PEARLES challenges and solutions to the implementation of clinical research responses to epidemics and pandemics: a scoping review.EClinicalMedicine · 2025Review
- Strengthening Vaccine Regulation: Insights from COVID-19 Vaccines, Best Practices, and Lessons for Future Public Health Emergencies.Vaccines · 2025Article
- Assessing Readability and Usability of Electronic Medicine Package Leaflets in South Korea: A Mixed-Methods Study.Drug, healthcare and patient safety · 2025Article
- Using artificial intelligence and predictive modelling to enable learning healthcare systems (LHS) for pandemic preparedness.Computational and structural biotechnology journal · 2024Review
- Promoting Collaboration of Regulators and Patients in Improving Drug Safety and Regulatory Decision Making.Drug safety · 2024Article
- [The role of regulatory agencies within health systems during emergencies in BrazilPapel de los organismos regulatorios en los sistemas de salud en situaciones de emergencia en Brasil].Revista panamericana de salud publica = Pan American journal of public health · 2024Article
- Regulatory agilities impacting review timelines for Pfizer/BioNTech's BNT162b2 mRNA COVID-19 vaccine: a retrospective study.Frontiers in medicine · 2023Article
- Collaborative training of regulators as an approach for strengthening regulatory systems in LMICs: experiences of the WHO and Swissmedic.Frontiers in medicine · 2023Article
- Diagnostic performance of CT lung severity score and quantitative chest CT for stratification of COVID-19 patients.La Radiologia medica · 2022Article
- Regulatory Flexibilities and Guidances for Addressing the Challenges of COVID-19 in the EU: What Can We Learn from Company Experiences?Therapeutic innovation & regulatory science · 2022Article
- Rolling Reviews During COVID-19: The European Union Experience in a Global Context.Clinical therapeutics · 2022Article
- Regulatory reliance pathways during health emergencies: enabling timely authorizations for COVID-19 vaccines in Latin America.Revista panamericana de salud publica = Pan American journal of public health · 2022Article
- Future directions in regulatory affairs.Frontiers in medicine · 2022Review
- The Utility of Remote Inspections During the COVID-19 Health Emergency and in the Postpandemic Setting.Clinical therapeutics · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeCrucial steps have been adopted by health and regulatory authorities around the world to respond to the COVID-19 pandemic. This review aims to highlight these steps by providing an overview of the regulatory approaches adopted during the onset of the pandemic, provide an assessment of observed trends, and offer some reflections and proposals to leverage learnings and opportunities from this current pandemic.
methodsDocuments and informational materials on regulating the development and management of medical products during the COVID-19 pandemic were collected and classified. These materials were sourced from official websites and press releases from health authorities and international bodies from selected markets across the globe, and covered the period between January and July 2020. Additional information to support this study was gathered through a literature review and analysis of related data available from the public domain, and was complemented with the authors' personal experience.
findingsCommunication has been vital in addressing the impact of COVID-19. A total of 1705 documents and informational materials related to health or regulatory response to the COVID-19 pandemic were gathered. Of these, 343 (around 20%) were identified as regulatory agilities. These agile approaches were classified into 3 categories, namely, where health and regulatory authorities had: (1) facilitated product management across the entire lifecycle, notably in expediting medical product use for COVID-19, ensuring the continuity of clinical trials, and addressing supply chain issues; (2) strengthened international cooperation; and (3) addressed regulatory burden with the adoption of electronic and digital tools. IMPLICATIONS: While many regulatory measures have been introduced temporarily as a response to the COVID-19 crisis, there are opportunities for leveraging an understanding from these approaches in order to collectively achieve more efficient regulatory systems and to mitigate and address the impact of COVID-19 and further future-proof the regulatory environment.
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What OpenQuestion holds
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.