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  1. Clinical Trials and Human Subject Protection

Good Clinical Practice (GCP) Inspection Collaboration with International Regulators for Drug Development

International good clinical practice (GCP) collaboration is a critical component to ensure adequate regulatory oversight and assessment of data integrity given: 

  • Globalized clinical trials and growing numbers of clinical trial sites per study  
  • Complex, dynamic, clinical trial design and delivery that may require new approaches to preserving data integrity  
  • Accelerated product approval programs requiring high level of efficiency for marketing applications 

FDA’s Center for Drug Evaluation and Research (CDER) has established collaborations with the European Medicines Agency (EMA), the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan, the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA-UK) and Health Canada to optimize regulatory resources and oversight in the evaluation of clinical trial conduct.

The international GCP collaborations include: 

  • Conducting collaborative GCP inspections  
  • Sharing inspection observations and findings through inspection sharing agreements 
  • Convening joint conferences to discuss data integrity in clinical trials 
  • Sharing knowledge and best practices related to GCP compliance to external stakeholders, including clinical investigators and industry  
  • Authoring joint publications  

International Joint Workshops on Good Clinical Practice (GCP)  

Subscribe to the FDA good clinical practice listserv for alerts when new conferences are announced. 

Publications, Articles, and Reports 

Information Sharing with International Regulatory Authorities  

FDA shares information with regulatory authorities that have an established confidentiality commitment. Learn about and search FDA confidentiality commitments. 


Additional Good Clinical Practice Regulatory Resources 

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