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

Introduction/objective: Clinical trial regulations (CTR) are essential for ensuring the safety, efficacy, and ethical conduct of drug development. However, the regulatory frameworks governing these trials vary significantly across different countries, affecting approval processes, trial conduct, and drug development timelines. This review examines the differences in clinical trial regulations in the USA, EU, Australia, and India between 2016 and 2024. The focus is on key regulatory aspects, such as the adoption of Good Clinical Practices (GCP), patient safety measures, and policies fostering innovation. By comparing drug regulations and trial management practices, it aims to identify regulatory challenges and propose improvements to enhance global harmonization.

Methods: A detailed review of drug regulations, acts, rules, and trial processes across different countries was conducted. The review compared global standards for clinical trials, focusing on costs, safety reporting, and trial management, and identifying key areas for improvement.

Conclusion: 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.