Who Regulates Clinical Trials Globally?

Clinical trials are regulated by both national and international bodies, including:

• FDA – United States
• EMA – European Union
• MHRA – United Kingdom
• CDSCO – India
• PMDA – Japan
• WHO – Sets global research ethics standards
• ICH-GCP – Provides international guidelines for trial conduct

These organizations review protocols, inspect sites, and approve or deny permission to conduct or continue a trial.