ReviewInternational journal of molecular sciences2019
Flexible and Expedited Regulatory Review Processes for Innovative Medicines and Regenerative Medical Products in the US, the EU, and Japan.
Review in International journal of molecular sciences, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 42 papers.
What it found
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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
42 citing papers in PubMed.
- Oral berotralstat for the prophylaxis of hereditary angioedema attacks in patients in Japan: A phase 3 randomized trial.Allergy · 2021Trial
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- Regulatory Convergence in Cell and Gene Therapy: Harmonizing Quality, CMC, and Approval Pathways Across the FDA, EMA, PMDA, and Emerging Markets.Biotech (Basel (Switzerland)) · 2026Review
- Review Performance of New Active Substances in Taiwan: A 10-Year Retrospective Analysis (2015-2024).Therapeutic innovation & regulatory science · 2026Article
- From Bench to Bedside: Translational Barriers in Mesenchymal Stem Cell Therapy for Intervertebral Disc Degeneration.Bioengineering (Basel, Switzerland) · 2026Review
- Clinical Benefit and Global Regulation of Bispecific Antibody Drugs: A Cross-sectional Analysis.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2026Article
- Exploring alternative funding mechanisms to improve patient access to innovative medicines.BMC health services research · 2026Article
- Global Pharmaceutical Regulation: Comparative Frameworks and Operations.Pharmacy (Basel, Switzerland) · 2026Review
- Mesenchymal Stromal/Stem Cell-Based Therapies for Liver Regeneration: Current Status and Future Directions.International journal of molecular sciences · 2026Review
- Article
- A comprehensive review of clinical trials and Progress in stem cell therapies for advanced heart failure.Regenerative therapy · 2025Review
- Strengthening the Use of International Collaborative Regulatory Assessments and Regulatory Alignment- Implications for Global Convergence.Therapeutic innovation & regulatory science · 2025Review
- Added Therapeutic Benefits of Top-Selling Drugs in Japan: A Cross-Sectional Study Using Health Technology Assessment.Clinical and translational science · 2025Article
- Do We Understand Unmet Need? A Proposal to Use Length-Of-Life Equivalent (LOLE) as a Patient-Centric Measure of Unmet Need.PharmacoEconomics - open · 2025Article
- Rare disease challenges and potential actions in the Middle East.International journal for equity in health · 2025Article
- Impact of regulatory measures on the approval timelines of advanced therapy medicinal products by the European Medicines Agency.Frontiers in medicine · 2025Article
- 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
- Factors associated with hematological adverse reactions of drugs authorized via the centralized procedure.Scientific reports · 2024Article
- Trends in orphan medicinal products approvals in the European Union between 2010-2022.Orphanet journal of rare diseases · 2024Article
- Surrogacy and the Valuation of ATMPs: Taking Our Place in the Evidence Generation/Assessment Continuum.PharmacoEconomics · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
1 author.
Funding
Abstract
Several expedited regulatory review projects for innovative drugs and regenerative medical products have been developed in the US, the EU, and Japan. Each regulatory agency has elaborated an original regulatory framework and adopted regulatory projects developed by the other regulatory agencies. For example, the Food and Drug Administration (FDA) first developed the breakthrough therapy designation, and then the Pharmaceuticals and Medical Devices Agency (PMDA) and European Medicines Agency (EMA) introduced the Sakigake designation and the priority medicines (PRIME) designation, respectively. In addition, the necessity of the product being first development in Japan is the original feature of the Sakigake designation, while actively supporting the development of advanced-therapy medicinal products (AMTPs) by academia or small/medium-sized sponsors is the original feature of the PRIME; these particular features are different from the breakthrough therapy designation in the US. In this review article, flexible and expedited review processes for new drugs, and cell and gene therapies in the US, the EU, and Japan are described. Moreover, all the drugs and regenerative medical products that were granted conditional approval or Sakigake designation in Japan are listed and analyzed herein.
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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.