JoVE - Journal of Visualized Experiments
JoVE Visualize
Contact Us

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

  • 0Amity Institute of Pharmacy-AIP Regulatory Affairs Noida India.
Reviews on recent clinical trials +

|

June 13, 2025

Abstract

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.

Related Concept Videos

Clinical Trials 01:16

6.6K

Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...

Clinical Trials: Overview 01:11

2.9K

Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...

Drug Regulation 01:25

1.3K

Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...

Preclinical Development: Overview 01:28

4.3K

Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...

Pharmacovigilance 01:19

788

Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches 01:23

124

Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...