CDER/FDA Regulations Regarding Foreign Clinical Trial Data

A pharma sponsor who wishes to rely on a foreign clinical trial data to support US IND and/or NDA application for marketing approval must comply with FDA regulatory rigor and meet specific criteria for data submissions under the auspice of CFR requirements.

21 CFR 312 (b) describes regulatory requirements for FDA acceptance of foreign clinical trial data and "detailed" descriptive procedures for study submission:

• Description of investigator qualifications
• Description of clinical study site qualifications
• Description of research facilities
• Detailed summary of the clinical protocol
• Detailed description of the clinical trial study
• Detailed subject case records, case report forms and source documentation
• Investigator subject records
• Description of drug product, including components, formulation, drug substance specifications
• BA/BE data
• Detailed documentation of drug efficacy and effectiveness in accordance with GCP and 21 CFR 314.26.
• Detailed documentation to demonstrate clinical trial conduct
• Detailed documentation to prove adequate and well-controlled clinical protocol.