CDER/FDA Regulations Regarding Foreign Clinical Trial Data

In the last 5 years, use and submission by pharmaceutical companies of non-US (foreign) data to FDA is on the rise. FDA sets conditions in the CFR Register under which such data can be used in support of clinical research, clinical submission and marketing application approval in the US. Non-US data must be reviewed for regulatory rigor, quality, statistical confidence, therapeutic value and clinical significance. I strongly recommend that a due diligence review and quality audit be performed on all non-US data and documentation prior to integration and submission to FDA.

CDER/FDA Requirements:

• Foreign studies are conducted under a filed IND with FDA
• If the studies are not conducted under a filed IND with FDA but meet criteria specified in FDA CFR regulations, exceptions to include non-US may be granted
• Foreign data and study documentation, final study reports must meet US IND 21 CFR 312 requirements.

CDER/FDA may accept foreign studies not conducted under a filed IND if the studies are:

• Well designed
• Well conducted
• Performed by qualified clinical investigators
• Performed at qualified clinical sites
• Conducted in accordance with ethical principles acceptable to the WHO
• Conducted in accordance with the Declaration of Helsinki
• Conducted in accordance with laws and regulations of the country where the clinical research is conducted
• Country-specific regulations meet standards set forth by with CDER/FDA - 21 CFR 312.120(a).