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)  

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• FDA, MHRA, and Health Canada Good Clinical Practice Workshop: Global Clinical Trials - Considerations and Lessons Learned from the Changing Landscape (2022)
• FDA and MHRA Good Clinical Practice Symposium: Data Integrity in Global Clinical Trials - Tackling Challenging Topics in 2020  
• FDA and MHRA Good Clinical Practice Workshop: Data Integrity in Global Clinical Trials (2018) 
  • • Welcome + Data Quality: Why Do We Care?  
    • Data Integrity from International Perspectives
    • Quality Management Systems and Quality by Design
    • Overview of Data Integrity
    • Good Clinical Practice Assessment of Data Reliability in Registration Trials
    • Quality and Control of Clinical Trial Data
    • The Data Management Plan – Pulling It All Together
    • Unblinding – Let Me Count the Ways…
    • Blinding of Bioequivalence Trials  
    • Effective Use of Audit Trails
    • A Case Example of the Review of Audit Trails in GCP Inspections

Publications, Articles, and Reports 

• Reflections on the regulatory experience of remote approaches to GCP and GMP regulatory oversight, International Coalition of Medicines Regulatory Authorities (ICMRA) (November 26, 2021)
  NOTE: This reflection paper by ICMRA was based on discussions about the combined GCP and GMP regulatory experiences of MHRA, EMA, Health Canada, US-FDA, Swissmedic, HPRA Ireland, AEMPS Spain, ANSM France, PEI Germany, MHLW/PMDA Japan, TGA Australia, ANVISA Brazil, HSA Singapore, WHO and Saudi-FDA.
• Tackling Challenging Data Integrity Topics in 2020: Update on Good Clinical Practice Perspectives from the US FDA and MHRA UK in Clinical Pharmacology & Therapeutics, Clinical Pharmacology & Therapeutics (August 6, 2021) 
• MHRA and US FDA tackle challenging data integrity, MHRA Blog Post (September 1, 2021) 
• EMA-FDA and PMDA GCP Pilot Collaboration Report, FDA, (2019) 

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. 

Contact

• Contact [email protected] for information on general FDA international collaboration
• Contact [email protected] for information on drug GCP international collaborations with the Center for Drug Evaluation and Research (CDER)

Additional Good Clinical Practice Regulatory Resources 

• Regulations: Good Clinical Practice and Clinical Trials