  
  
G/TBT/N/KOR/1004  
2 November 2021  
(21-8324) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  English  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member:  REPUBLIC OF KOREA   
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:  Ministry of Food and Drug Safety  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above:   
Documents are available from the Ministry of Food and Drug safety website 
(www.mfds.go.kr ). 
 
Also available from:  
International Cooperation Office  
Ministry of Food and Drug Safety  
187 Osongsaengmyeong2 -ro, Osong -eup, Heungdoek -gu Cheongju -si, 
Chungcheongbuk -do, 363 -700  
Republic of Korea  
Tel: (+82) 43 719 -1564 
Fax: (+82) 43 -719-1550 
Email: wtokfda@korea.kr  
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  
5. Title, number of pages and language(s) of the notified document:  Regulation on 
Safety of Pharmaceuticals, etc. (46 page(s), in Korean)  
6. Description of content:  This is to determine the matters entrusted by the law and the 
details necessary for its implementation including monitoring the implementation of 
procedures and conditions necessary for Conditional Marketing Authorization (CMA) and 
establishing Standard Operation Procedure (SOP) for Site Management Organization 
(SMO) and the Central Institution Review Board (IRB), following the revision of 
'Pharmaceutical Affa irs Act' (Act No.18307, Promulgation Date, 20 Jul, 2021, Enforcement 
Date, 21 Jan, 2022), which aims to provide legal basis on CMA which authorizes marketing 
under the condition that clinical trials result for the medicine user should be submitted 
and clin ical trials consigned and conducted by IRB.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  To compensate the inadequacies of the current operating system; Other  G/TBT/N/KOR/1004  
 
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  8. Relevant documents:   
Notification No. 2021-505 by MFDS (19 OCT, 2021)  
9. Proposed date of adoption:  To be determined  
Proposed date of entry into force:  To be determined  
10. Final date for comments:  60 days from notification  
11. Texts available from:  National enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
Korea WTO TBT Enquiry Point  
Technical Barriers to Trade (TBT) Division  
Korean Agency for Technology and Standards (KATS)  
93 Isu -ro Maengdong -myeon Eumseong -gun 
Chungchungbuk -do  
27737  
+(82) 43 870 5525  
+(82) 43 870 5682 (Fax)  
tbt@korea.kr  
http://www.knowtbt.kr  
https://members.wto.org/crnattachments/2021/TBT/KOR/21_6959_00_x.pdf  
 