G/TBT/N/KOR/825  
 
24 April 2019  
(19-2719) 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 (MFDS) website 
(www.m fds.go.kr). Also available from:  
International Cooperation Office  
Ministry of Food and Drug Safety  
187 Osongsaengmyeong2 -ro, Osong -eup, Heungdeok -gu, Cheongju -si, 
Chungcheongbuk -do, 28159  
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:  A partial 
amendment to Regulation for Pharmaceutical Approvals, Notifications and Reviews 
(15 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 MFDS Notice "Regulation for 
Pharmaceutical Approvals, Notifications and Reviews" as follows:  
- The scope of pharmaceuticals that are  required to submit Common Technical 
Document (CTD) for review under Article 6 would be expanded to include preparations 
for which specialty dosage forms are authorized (such as extended  release products) and 
the drugs requiring safety and efficacy assessm ent such as injections, ophthalmic 
solutions and otic solutions whose excipients are different from those of the previously 
approved drug.  
- When drugs are outsourced for manufacturing in the manufacturing sites drugs 
manufactured from which have gone thro ugh bio  equivalence  (BE) test, they are newly 
required under Article 28 to submit BE test data for review.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  To harmonize global regulation of generic medicines  G/TBT/N/KOR/825  
 
- 2 - 
 
  8. Releva nt documents:   
• MFDS NOTIFICATION No. 2019 -192 (15 April 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@kats.go.kr   
website: http://www.knowtbt.kr  
https://members.wto.org/crnattachments/2019/TBT/KOR/19_2388_00_x.pdf