ReviewTherapeutic innovation & regulatory science2025
Strengthening the Use of International Collaborative Regulatory Assessments and Regulatory Alignment- Implications for Global Convergence.
Review in Therapeutic innovation & regulatory science, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 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
4 citing papers in PubMed.
- Measuring the Outcomes of International Oncology Regulatory Collaboration in Canada from 2019 to 2025: Project Orbis.Clinical pharmacology and therapeutics · 2026Article
- Advancing Wider Implementation of Multi-regional Clinical Trials in East Asia.Therapeutic innovation & regulatory science · 2026Review
- Article
- The United Nations convention on rare diseases-A framework for research prioritization.Frontiers in public health · 2025Article
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 has been a significant growth in international regulatory information-sharing and work-sharing initiatives in recent years, leading to reductions in submission lag and regulatory review timeframes. However, regulatory approvals in some major countries can still lag by months or years after the first global approval, with impacts on availability of new medicines for patients. This review assesses the impact of current international collaborative initiatives and proposes some options for their advancement. It also explores the potential impact of other factors such as greater alignment and collaboration on facilitated pathways, Good Manufacturing Practice) GMP inspections on regulatory timeframes and makes suggestions for improvements of regulatory convergence, collaboration, reliance and administrative procedures. While international collaborative regulatory assessments are still relatively new, in the following years, we consider that these pathways will become even more routine and impactful, especially if they can be further adapted.
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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.