. /.  WORLD TRADE  
ORGANIZATION  G/TBT/N/USA/63 
21 June 2004 
 (04-2683) 
Committee on Technical Barriers to Trade Original:  English 
   
NOTIFICATION 
 
The following notification is being circ ulated in accordance with Article 10.6. 
 
1. Member to Agreement notifying:   UNITED STATES
 
If applicable, name of local government involved (Articles 3.2 and 7.2):         
2. Agency responsible:   Department of Health and Human Services, Food and Drug 
Administration  (FDA)  (67) 
Name and address (including telephone and fax numbers, e-mail and web-site 
addresses, if available) of  agency or authority designated to handle comments 
regarding the notification shall be  indicated if different from above:         
3. Notified under Article 2.9.2 [ X], 2.10.1 [   ], 5.6.2 [   ], 5.7.1 [   ], other:         
4. Products covered (HS or CCCN where applicable, otherwise national tariff heading. 
ICS numbers may be provided in  addition, where applicable):   Pharmaceutical Clinical 
Studies  (HS Chapter 3004) (ICS 11.120). 
5. Title, number of pages and language(s) of the notified document:   Human Subject 
Protection; Foreign Clinical Studies Not C onducted Under an Investigational New Drug 
Application (9 Pages,  in English) 
6. Description of content:   The Food and Drug Administration (FDA) is proposing to revise 
its regulations on its acceptance of forei gn 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 that such studies be conducted in accordance with ethical  principles stated in the Declaration of 
Helsinki (Declaration) with a requirement th at the studies be conducted in accordance with 
good clinical practice (GCP), including review  and approval by an independent ethics 
committee (IEC). The proposed rule is intended to update the standa rds for the acceptance 
of non IND foreign studies and to help ensure  the quality and integrity of data obtained 
from such studies. 
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of Human Life and Health. 
8. Relevant documents:   69 Federal Register (FR) 32467 10 June 2004; Title 21 Code of 
Federal Regulations (CFR) Part 312.  Will app ear in the Federal Register when adopted. 
9. Proposed date of adoption:   
Proposed date of entry into force:   }To be determined 
10. Final date for comments:   8 September 2004 G/TBT/N/USA/63 
Page 2  
 
11. Texts available from:  National enquiry point [ X] or address, telephone and fax 
numbers, e-mail and web-site addresses, if available of the other body:        
Internet URLs: 
http://a257.g.akamaitech.net/7/257/24 22/06jun20041800/edocket.access.gpo.gov/2004/04-
13063.htm  
http://a257.g.akamaitech.net/7/257/24 22/06jun20041800/edocket.access.gpo.gov/2004/pdf/
4-13063.pdf  
 