G/TBT/N/KOR/727  
 
19 September 2017  
(17-4941) 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 
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. I CS numbers may be provided in addition, where applicable): Advanced 
Biological Products  
5. Title, number of pages and language(s) of the notified document: Proposed 
enactment to the "Advanced Biological Products Act" (57 page(s), in Korean)    
6. Description of content: The purposes of the Advanced Biological Product Act are to: (a) 
establish a safety control system that covers the whole product life cycle (b) stipulate the 
list of advanced biological products which are subject to accelerated appro val and its 
procedure.  
Article 2: definition(s)  
Designates cell therapy products, gene therapy products, tissue -engineered products, 
combined advanced therapy medicinal products and other products recognized by the 
Minister of Food and Drug Safety as adva nced biological products.  
Also, the same article provides definitions of human -derived cells, etc. and management 
control of human -derived cells, etc.  
Article 15: Importation of advanced biological product  
Any person who intends to import advanced biologic al products shall declare import 
business and obtain import permission per each product.  
From Article 16 to Article 19: Management control of advanced biological product  
Any person who intends to engage in management control of human -derived cells shall G/TBT/N/KOR/727  
 
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  obtain an approval from the Minister of Food and Drug Safety.  
Establish a compliance list for collection of human -derived cells and control and prevention 
of advanced biologics products -induced diseases.  
From Article 21 to Article 25: Handling of advanced b iological product  
The Minister of Food and Drug Safety may designate an advanced biological product as a 
product subject to long -term follow -up investigation should it deem an investigation is 
required to examine the association between the adverse event a nd administration of the 
product.  
If investigation of adverse event is deemed required, the administered advanced biological 
product may be designated as a product subject to long -term follow -up investigation, the 
adverse event shall be investigated, and t he product's administration record shall be kept.  
Stipulates requirements for packaging, container, and package insert of advanced 
biological products.  
7. Objective and rationale, including the nature of urgent problems where 
applicable: Protection of human health and safety  
8. Relevant documents:  Draft Act on Advanced biological products (Proposal 
Number   8812, 28 August 2017)  
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 A gency 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 5682  
E-mail: tbt@kats.go.kr   
Website: http://www.knowtbt.kr  
 
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