Clarification on Foreign Clinical Studies Requirements for PAR-05-010 – Cooperative Drug Development Group (CDDG) for the Treatment of Mental Illness

Notice Number: NOT-MH-06-122

Key Dates
Release Date:  September 11, 2006

Issued by
National Institute of Mental Health (NIMH), (http://www.nimh.nih.gov/)

The objective of PAR-05-010 is to “establish CDDGs to conduct innovative, high impact clinical research focused on the clinical development of IND-ready pharmacological agents targeting novel molecular targets implicated in the pathophysiology of mental illness.”  To date, NIMH has required that applicants to PAR-05-010 certify within their grant submission that an Investigational New Drug application for the relevant compound has been filed with the FDA and provide the date of the filing (NOT-MH-05-017).  However, in applications that propose a clinical study that will take place entirely in a foreign country using a pharmacological agent approved by that country’s federal regulatory agency, NIMH will not require an Investigational New Drug (IND) application for the relevant compound be filed with the FDA nor require provision of the date of the filing.  Nevertheless, these foreign clinical studies not conducted under an IND must meet criteria set out in 21 CFR 312.120, including being well designed, well conducted, performed by qualified investigators, and conducted in accordance with ethical principles acceptable to the world community.

Inquiry

Inquiries regarding this Notice may be directed to:

Mi Hillefors, M.D., Ph.D.
Division of Adult Translational Research and Treatment Development
National Institute of Mental Health
6001 Executive Boulevard, Room 7125, MSC 9632
Bethesda, MD 20892-9632
Telephone: (301) 443-2738
Email: hilleform@mail.nih.gov


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