ReviewClinical pharmacology and therapeutics2020
Are the European Medicines Agency, US Food and Drug Administration, and Other International Regulators Talking to Each Other?
Review in Clinical pharmacology and therapeutics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 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
25 citing papers in PubMed.
- A decade comparison of regulatory decision patterns for oncology products to all other non-oncology products among Swissmedic, European Medicines Agency, and US Food and Drug Administration.Clinical and translational science · 2023Trial
- Navigating through toxicological data: review of toxicological databases and sources in the interdisciplinary context including-chemicals, cosmetics, pharmaceuticals and forensics.Archives of toxicology · 2026Review
- Harnessing Machine Learning for Accelerated Drug Discovery: Opportunities and Unmet Challenges.Pharmaceuticals (Basel, Switzerland) · 2026Review
- Navigating Regulatory Complexities in Biosimilar Approvals and Imports for Autoimmune Disorder Management: A Comparative Analysis of FDA (US), EMA (EU), and CDSCO (India) Guidelines.Recent advances in drug delivery and formulation · 2026Article
- Strengthening the Use of International Collaborative Regulatory Assessments and Regulatory Alignment- Implications for Global Convergence.Therapeutic innovation & regulatory science · 2025Review
- Therapeutic Potential of Natural Xanthones Against Prostate Adenocarcinoma: A Comprehensive Review of Research Trends During the Last Ten Years (2014-2024).Pharmaceuticals (Basel, Switzerland) · 2025Review
- Biocontrol and Nanotechnology Strategies for Postharvest Disease Management in Fruits and Vegetables: A Comprehensive Review.Foods (Basel, Switzerland) · 2025Review
- Induced Pluripotent Stem Cells in Cardiomyopathy: Advancing Disease Modeling, Therapeutic Development, and Regenerative Therapy.International journal of molecular sciences · 2025Review
- Discrepancies in regulations in post-marketing safety surveillance of drug-device combination products in the EU and US: a review.Frontiers in drug safety and regulation · 2025Review
- Computational tools and data integration to accelerate vaccine development: challenges, opportunities, and future directions.Frontiers in immunology · 2025Review
- Regulatory pathways and guidelines for nanotechnology-enabled health products: a comparative review of EU and US frameworks.Frontiers in medicine · 2025Review
- Barriers to and enablers of Pakistani pharmaceutical export to regulated markets: regulatory perspective.Journal of pharmaceutical policy and practice · 2025Article
- A real-world disproportionality analysis of semaglutide: Post-marketing pharmacovigilance data.Journal of diabetes investigation · 2024Article
- From Drug Discovery to Drug Approval: A Comprehensive Review of the Pharmacogenomics Status Quo with a Special Focus on Egypt.Pharmaceuticals (Basel, Switzerland) · 2024Review
- Synthesis of 1,2,3-triazole-piperazin-benzo[RSC advances · 2024Article
- Review
- Considering Global Development? Insights from Applications for FDA Breakthrough Therapy and EMA PRIME Designations.Therapeutic innovation & regulatory science · 2023Review
- Activity and perspective on quantitative modeling and simulation in Japan: Update from the Pharmaceuticals and Medical Devices Agency.CPT: pharmacometrics & systems pharmacology · 2022Article
- The Hitchhiker's Guide to Human Therapeutic Nanoparticle Development.Pharmaceutics · 2022Review
- Common Commentary on Paediatric Oncology Drug Development Published: Another Step in Optimising Global Regulatory Coordination of Paediatric Development Plans.Therapeutic innovation & regulatory science · 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
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
There is talk of regulatory collaboration worldwide to protect public health and allow patients timely access to medicines. Here, we present the reality of the collaboration between the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). This takes the form of near daily interactions, which may be less known outside of regulatory agencies. We present a review of what we call clusters, which involve the EMA, the FDA, and many other agencies under the umbrella of confidentiality arrangements. Through a survey of participants, we identified about 30 clusters of variable composition; these allow for the exchange of information and discussion among experts of applying regulatory science to common challenges in global drug development at every phase of its lifecycle and facilitate global medicines development.
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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.