. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/KOR/129 
20 December 2006 
 (06-6101) 
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:   REPUBLIC OF KOREA
 
If applicable, name of local government involved (Articles 3.2 and 7.2):         
2. Agency responsible:   Korea Food and Drug Administration 
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, Quasi-d rug, Sanitary products 
5. Title, number of pages and lang uage(s) of the notified document:   
Proposed Amendments of ‘Regulations for Revi ew of safety and Efficacy of Drugs, Etc. 
6. Description of content:   Major proposed revisions are as follows : 
(a)  To harmonize the type of required doc uments with international standards, 
and add safety pharmacology test da ta to the required data list. 
(b) To subdivide scope of required docum ents on safety and efficacy for new 
additives. 
(c)  In accordance with international standa rds, to modify the scope of stability 
data KFDA accepts regarding new pharmaceutical products and non-new 
drugs requiring data submission. 
(d) To add drugs meeting Bioequivalence Test Standards and inhalants for 
general anaesthetics to the list of dr ugs for which equi valence data can 
substitute bioequivalence test data  as part of required documents. 
(e) To permit data to be submitted after the drug's introduction into the market 
or exempt data submission for some toxi city data that takes a long period of 
time to prepare. 
(f) To exclude drugs that are registered with  established oriental books  and 
have the same route of administration, but different dosage form, from the list of prescriptions that are subject to safety and efficacy data review. G/TBT/N/KOR/129 
Page 2  
 
  (g) To shorten the review period by perm itting a subsequent applicant to apply 
for safety and efficacy data review if  item licensing of the subsequent drugs 
that are identical with the original drug subject to the post-market surveillance are made after  the expiration of the post-market surveillance 
period. 
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of human health 
8. Relevant documents:   The Korea Food and Drug Administration Advance Notice 
No. 2006-248, 13 December 2006 (Available in Korean). 
9. Proposed date of adoption:   
Proposed date of entry into force:   }To be determined 
10. Final date for comments:   12 February 2007 
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:   
Documents are available from the Korea Food and Drug Administration website at 
www.kfda.go.kr.   
Also available from:   International Trade & Cooperation Team 
Korea Food and Drug Administration 
#194 Tongilro, Eunpyeong-gu  
Seoul, 122-704 Republic of Korea   Tel: +82 2 380 1661 Fax: +82 2 356 2893 
E-mail:  wtokfda@kfda.go.kr