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.
Authors
- Shubham Suryavanshi
- Navneet Sharma (ORCID: https://orcid.org/0000-0002-5499-5301)
- Vikesh Kumar Shukla (ORCID: https://orcid.org/0000-0001-7208-8003)
- Munish Sharma
- Munita Grover (ORCID: https://orcid.org/0009-0003-2207-2312)
Institutions
- Amity University (IN)
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