Policymed: April 11, 2012.
On April 28, 2008, the Food and Drug Administration (FDA) amended its regulations on the acceptance of foreign clinical studies not conducted under an investigational new drug application (IND) (“non-IND foreign clinical studies”) as support for an IND or a new drug application (NDA), abbreviated new drug application (ANDA), or a biologics license application (BLA) (collectively known as “marketing applications” or “applications for marketing approval”).
The final rule requires that such studies be conducted in accordance with good clinical practice (GCP), including review and approval by an independent ethics committee (IEC) and informed consent from subjects. The GCP requirements in the final rule encompass both ethical and data integrity standards for clinical studies. This final rule, which took effect on October 27, 2008, is codified at 21 CFR 312.120. It is intended to help ensure the protection of human subjects enrolled in non-IND foreign clinical studies as well as the quality and integrity of the resulting data.
To address the changes from this final rule, FDA recently released a Guidance for Acceptance of Foreign Clinical Studies Not Conducted Under an IND is intended to clarify for sponsors and applicants how they can demonstrate compliance with these requirements. The guidance is part of FDA’s efforts to encourage sponsors and applicants to standardize information relating to foreign clinical trials in their INDs and applications for marketing approval. Read more