  
  
G/TBT/N/KOR/1117  
2 December 2022  
(22-8980) 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, 28159  
Republic of Korea  
Tel: (+82) 43 719 -1564 
Fax: (+82) 43 -719-1550 
Email: intmfds@korea.kr  
3. Notified under Article 2.9.2 [X], 2.10.1 [  ], 5.6.2 [X], 5.7.1 [  ], 3.2 [  ], 7.2 [  ], 
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:  Proposed 
partical amendments to the "Standard on Pharmaceutical Equivalence Test"; (41 page(s), 
in Korean)  
6. Description of content:  The proposed amendment to the Standard on Pharmaceutical 
Equivalance Test is as follows:  
1) Add standards for designating Reference Listed Drugs in accordance with the expanded 
scope of drugs subject to pharmaceutical equivalence study;  
2) Harmonize bioequivalence criteria for narrow therapeutic index drugs with international 
standards;  
3) Str engthen management of excipient changes by taking into consideration the 
formulations of products; and  
4) Recalibrate pharmaceutical equivalence study document requirements for cases when 
manufacturing procedures and sites are changed  
7. Objective and rat ionale, including the nature of urgent problems where 
applicable:  Protection of human health or safety  G/TBT/N/KOR/1117  
 
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  8. Relevant documents:  MFDS NOTIFICATION No. 2022 -521, (24 November 2022)  
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:   
Technical Barriers to Trade (TBT) Division  
Korean Agency for Technology and Standards (KATS)  
93, Isu -ro, Maengdong -myeon, Eumseong -gun, Chungcheongbuk -do, Republic of Korea, 
369-811 
Tel.: (+82) 43 870 5521 Fax: (+82) 43 870 5682  
E-mail: tbt@korea.kr  Website: http://www.knowtbt.kr  
https://members.wto.org/crnattachments/2022/TBT/ KOR/22_8255_00_x.pdf  
 