G/TBT/N/KOR/868  
10 December 2019  
(19-8507) 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, 
Chungcheongbukdo,  
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 [   ], 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:  Standard on 
Pharmaceutical Equivalence Study (9 page(s), in Korean)  
6. Description of content:  The Ministry of Food and Drug Safety (MFDS) of the Republic 
of Korea is issuing the proposed amendments to the regulation notified as MFDS Notice 
"Standard on Pharmaceutical Equivalence Study". The content of the amendments is as 
follows.  
1. In an aim to enhance the credibility for the quality of generic drugs, the acceptance 
criteria of bioequivalence study have been adjusted upwards to the level of advanced 
countries. Also, the standards on the selection of reference products in case of approval 
for chan ge have been strengthened.  
2. Pharmaceutical equivalence study shall only be conducted with referenced products 
published by MFDS. In addition, the exemption criteria have been modified for 
bioequivalence tests between products that have been proved to be bioequivalent to its 
originals and the products that are also bioequivalent but have different strength with 
them.  G/TBT/N/KOR/868  
 
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  7. Objective and rationale, including the nature of urgent problems where 
applicable:  To harmonize with global regulations on generic medici nes 
8. Relevant documents:   
• MFDS NOTIFICATION No. 2019 -541 (27 November 2019)  
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, 27737 Republic of 
Korea  
Tel.: (+82) 43 870 5525 Fax: (+82) 43 870 5682  
E-mail: tbt@korea.kr  Website: http://www.knowtbt.kr  
https://members.wto.org/crnattachments/2019/TBT/KOR/19_7037_00_x.pdf