G/TBT/N/KOR/893  
19 May 2020  
(20-3695) 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:   
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: intmfds@korea.kr  
Website: www.mfds.go.kr  
3. Notified under Article 2.9.2 [   ], 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):  
Biological  Products; Other (HS 300190); Other (HS 300490)  
5. Title, number of pages and language(s) of the notified document:  Enforcement 
decree of the Act on advanced regenerative medic ine and advanced biological products 
regarding safety and support (71 page(s), in Korean)  
6. Description of content:      
- As the "Act on Safety and Support of Advanced Regenerative Medicine and Advanced 
Biological Products" is established, "Enforcement D ecree of the Act on Safety and Support 
of Advanced Regenerative Medicine and Advanced Biological Products" is enacted to 
prescribe the matters delegated by the Act and those necessary for its implementation.  
- Article 31: to prescribe facility standards required for the notification of importing 
business of advanced biological products.  
- Article 32: to prescribe   facilities, equipment, human resources, and quality management 
system required for the approval of human cell management business, etc.  
- Article 34 -36: 1) to stipulate that long -term follow -up investigations may be conducted 
on certain advanced biological products containing stem cell treatments, animal tissue and 
cells, gene therapy products and ot her advanced biological products that need to be 
monitored for adverse events over a specific period after administration. 2) to prescribe 
matters related to the designation as a subject of such investigations, the withdrawal of 
the designation, etc.  G/TBT/N/KOR/893  
 
- 2 - 
 
  7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health or safety  
8. Relevant documents:   
• MOHW Public  Notification No. 2020 -0299 (21 April 2020)  
• G/TBT/N/KOR/891  
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 5525  
Fax: (+82) 43 870 568 2 
E-mail: tbt@korea.kr   
Website: http://www.knowtbt.kr  
https://members.wto.org/crnattachments/202 0/TBT/KOR/20_3285_00_x.pdf