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HHS/FDA RIN: 0910-AF15 Publication ID: Fall 2003 
Title: ●Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application  
Abstract: The proposed rule would update the standards for the acceptance of foreign clinical studies not conducted under an investigational new drug application (IND) as support for an IND or marketing application for a drug or biological product. We are proposing to replace the requirement in 21 CFR 312.120 that non-IND foreign clinical studies be conducted in accordance with ethical principles stated in the Declaration of Helsinki. We would replace that with a requirement that such studies be conducted in accordance with good clinical practice (GCP), including review and approval by an independent ethics committee. The proposed GCP standard is consistent with the standard of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use for GCP and is sufficiently flexible to accommodate differences in how countries regulate the conduct of clinical research and obtain the informed consent of patients. 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Undetermined  Unfunded Mandates: Undetermined 
CFR Citation: 21 CFR 312.120   
Legal Authority: 21 USC 355(d)(5)    21 USC 355(i)    21 USC 371(a)    42 USC 262(a)(2)(A)    42 USC 262(a)(2)(B)(i)(l)   
Legal Deadline:  None
Action Date FR Cite
NPRM  05/00/2004    
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
Agency Contact:
Brian L. Pendleton
Senior Policy Advisor
Department of Health and Human Services
Food and Drug Administration
Suite 3037 (HFD-7), Office of Policy, WO 32, Room 4245, 10903 New Hampshire Avenue,
Silver Spring, MD 20993-0002
Phone:301 796-4614
Fax:301 847-8616

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