. /.WORLD TRADE
ORGANIZATIONG/TBT/N/KOR/31
25 March 2002
(02-1511)
Committee on Technical Barriers to Trade Original:  English
NOTIFICATION
The following notification is being circulated in accordance with Article 10.6.
1. Member to Agreement notifying:   REPUBLIC OF KOREA
If applicable, name of local government involved (Articles 3.2 and 7.2):           
2. Agency responsible:   Ministry of Health and Welfare
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):   Pharmaceuticals etc.
5. Title, number of pages and language(s) of the notified document:   Public Notification of
Draft Amendment of "Pharmaceutical law enfo rcement regulation (35 pages, in Korean)
6. Description of content:   Revision of articles related to clinical trials
To strengthen the obligation of a clinical trial sponsor
- A clinical trial should begin within 1 year from the approval of clinical trial
protocol ;
- A sponsor should provide the clinical trial investigator with a investigation brochure
before trial and inform them when new data and information are obtained
concerning safety and efficacy
- Completion should be reported within 20 days from the completion of clinical trial
Korea Food and Drug Administration can cancel  the approval of clinical trial protocol
when;
- Trial subject may be exposed to serious disease or damage
- Drugs for clinical trials are distributed for other purpose (i.e. not for clinical trials)
To prepared concrete procedures and standards for the bio-equivalence test.
7. Objective and rationale, including the na ture of urgent problems where applicable:
Health
8. Relevant documents:   MOHW notification 2002-26 (25.2.2002)
9. Proposed date of adoption:
Proposed date of entry into force: }May 2002G/TBT/N/KOR/31
Page 2
10. Final date for comments:   13 April 2002
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:
International Cooperation Division
Office of Planning and Management
1 Jungang-Dong
Kwacheon-CityKyoungi-Do, 427-760
Republic of Korea
Telephone: +82-2-2110-6152
Fax: +82-2-504-6418