Comparative Review of Clinical Trial Regulations in Different Countries: Current Scenario and Future Prospect

The findings reveal that while the studied countries have established strict regulatory frameworks, still there are specific areas for improvement. A key recommendation is to formally authorize Clinical Research Organizations (CROs) to enhance the quality and oversight of clinical trials. Additionally, specific regulations for herbal medicine trials are urgently needed to ensure safety and efficacy. Ethical concerns, especially regarding pediatric and orphan drug products, require more robust oversight. Integrating blockchain technology is also recommended to improve transparency and traceability in drug development. Finally, promoting global regulatory harmonization is crucial to minimize delays in patient access to essential therapies. These insights aim to guide policymakers, researchers, and stakeholders in enhancing the quality, safety, and accessibility of medicines.

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Publication Details

Journal
Reviews on Recent Clinical Trials
Published
2025-06-13
DOI
https://doi.org/10.2174/0115748871365320250529125930
Primary Topic
Health Systems, Economic Evaluations, Quality of Life
Type
article
Field-Weighted Citation Impact
0.00
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article

Comparative Review of Clinical Trial Regulations in Different Countries: Current Scenario and Future Prospect

Shubham Suryavanshi, Navneet Sharma, Vikesh Kumar Shukla, Munish Sharma et al.
Reviews on Recent Clinical Trials
Health Systems, Economic Evaluations, Quality of Life
article

Comparative Review of Clinical Trial Regulations in Different Countries: Current Scenario and Future Prospect

Shubham Suryavanshi, Navneet Sharma, Vikesh Kumar Shukla, Munish Sharma, Munita Grover
article en

Abstract

The findings reveal that while the studied countries have established strict regulatory frameworks, still there are specific areas for improvement. A key recommendation is to formally authorize Clinical Research Organizations (CROs) to enhance the quality and oversight of clinical trials. Additionally, specific regulations for herbal medicine trials are urgently needed to ensure safety and efficacy. Ethical concerns, especially regarding pediatric and orphan drug products, require more robust oversight. Integrating blockchain technology is also recommended to improve transparency and traceability in drug development. Finally, promoting global regulatory harmonization is crucial to minimize delays in patient access to essential therapies. These insights aim to guide policymakers, researchers, and stakeholders in enhancing the quality, safety, and accessibility of medicines.

Reviews on Recent Clinical TrialsVol. 20
Amity University (IN)
Openalex Percentile: Top 80%
Health Systems, Economic Evaluations, Quality of Life
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Comparative Review of Clinical Trial Regulations in Different Countries: Current Scenario and Future Prospect — Shubham Suryavanshi, Navneet Sharma, et al. · Reviews on Recent Clinical Trials (2025) | TGRS Research Map | TGRS