ArticleJournal of tissue engineering and regenerative medicine2018
Comparison of the new Japanese legislation for expedited approval of regenerative medicine products with the existing systems in the USA and European Union.
Article in Journal of tissue engineering and regenerative medicine, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 1 of them a synthesis that pooled it.
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
15 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Decision Support Tools for Regenerative Medicine: Systematic Review.Journal of medical Internet research · 2018Pooled it
- From Bench to Bedside: Translational Barriers in Mesenchymal Stem Cell Therapy for Intervertebral Disc Degeneration.Bioengineering (Basel, Switzerland) · 2026Review
- Designs of the clinical trials aiming at evaluating cell and gene therapy products: A critical appraisal from a literature review.Molecular therapy. Advances · 2026Review
- Article
- Analysis and comparative evaluation of expedited programs for gene therapy products: insights from the United States, the European Union, Japan, and South Korea.Gene therapy · 2024Article
- Standardisation is the key to the sustained, rapid and healthy development of stem cell-based therapy.Clinical and translational medicine · 2024Review
- Cell and gene therapy approvals in Japan and the need for international harmonization.Nature biotechnology · 2024Article
- Goals and Challenges of Stem Cell-Based Therapy for Corneal Blindness Due to Limbal Deficiency.Pharmaceutics · 2021Review
- Global regulatory progress in delivering on the promise of gene therapies for unmet medical needs.Molecular therapy. Methods & clinical development · 2021Review
- Advanced Therapy Medicinal Products for the Eye: Definitions and Regulatory Framework.Pharmaceutics · 2021Review
- Advances in regenerative therapy: A review of the literature and future directions.Regenerative therapy · 2020Review
- Liver tissue engineering: From implantable tissue to whole organ engineering.Hepatology communications · 2018Review
- Comparison of the new Japanese legislation for expedited approval of regenerative medicine products with the existing systems in the USA and European Union.Journal of tissue engineering and regenerative medicine · 2018Article
- An evaluation of drug lag for new drugs approved by the Indian regulator relative to the United States, European Union, and Japanese regulatory agencies: A 15-year analysis (2004-2018).Perspectives in clinical researchArticle
- Current standards and ethical landscape of engineered tissues-3D bioprinting perspective.Journal of tissue engineeringReview
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
Legislation for expedited-approval pathways and programmes for drugs, biologics or medical devices has been enacted for rapid commercialization of innovative products in the United States of America (USA) and the European Union (EU). However, less innovative products are increasingly benefitting from these expedited-approval pathways, and obligations to collect and report post-marketing data on approved products are being bypassed frequently. The Japanese government recently enacted legislation for a new conditional and time-limited approval pathway dedicated to regenerative medicine products. The current study examines this new legislation and compares it with existing US and EU regulatory frameworks, with a particular focus on how it addresses the limitations of existing systems. Regulations, guidance documents and approval information were gathered from the websites of the respective authorities in the USA, the EU and Japan, and the systems were categorized through qualitative analysis. The pathways and programmes from each region were categorized into four groups, based on the requirement of pre- or post-marketing clinical data. Expedited-approval pathways in the USA and the EU provide similar qualification criteria, such as severity of target disease; however, such criteria are not specified for the new pathway in Japan. Only the Japanese pathway stipulates a time limitation on exceptional approval, requiring post-marketing study for conditional and time-limited products. Continuous improvement is necessary to solve previously addressed issues within the expedited-approval pathways and programmes and to ensure that innovative medical products are rigourously screened, but also readily available to patients in need. The time limitation of conditional approval could be a potential solution to some of these problems. Copyright © 2017 The Authors. Tissue Engineering Regenerative Medicine published by John Wiley & Sons, Ltd.
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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.