G/TBT/N/KOR/928  
21 October 2020 
(20-7275) 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 [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:  The draft 
regulation of the "Act on pharmaceutical development and support for Public Health Cr isis 
Response" (15 page(s), in Korean)  
6. Description of content:  The Ministry of Food and Drug Safety of the Republic of Korea 
is proposing the draft regulation on the "Act on pharmaceutical development and support 
for Public Health Crisis Response". The  main contents  are: 
1) Introduction of pharmaceutical designation system for Public Health Crisis Response to 
effectively develop and supply medicines for treatment diseases that pose a threat to 
public health (Article 5 of the proposal).  
2) The Minister of Food and Drug Safety will provide administrative support to those who 
intends to develop medicines for public health crisis response, international exchange of 
technology and human resources, international joint research and development,  and 
implementation of international joint clinical trials (Article 6 and Article 7 of the Proposal).  
3)  In order to shorten the review period for marketing approval item of pharmaceutical 
for public health crisis response, clinical trials data shall be submitted at each 
development process and a frequent accompanying review system will be introduced to 
review the result in advance (Article 8 of the Proposal).  
4) Where the application for marketing approval item of pharmaceutical for public health 
crisis response is filed, review for the application shall be taken precedence over the 
review for the other medicines (Article 9 of the Proposal)  G/TBT/N/KOR/928  
 
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  5) The conditional permission of marketing approval item will be introduced, the 
permission enables to grant marketi ng approval item with condition that specific medicinal 
process is implemented to the patient for the pharmaceutical for public health crisis 
response, if the process is not implemented, the marketing approval will be revokes 
(Article 10 of the proposal).  
6) The Minister of Food and Drug Safety assesses the overall therapeutic value and notify 
the result by taking into account the safety and efficacy of pharmaceutical for public health 
crisis response, and the person who has granted marketing approval item shall explore 
safety precaution for said pharmaceutical for public health crisis response and report it to 
the minister (Article 11 and Article 12 of the proposal).  
7) A person who has granted marketing approval item can support the patient treatment 
such as providing the patient in need with pharmaceutical free of charge (Article 13 of 
the proposal).  
8) A person who intends to obtain permission for manufacturing a medical device, which 
is composed of a combination of pharmaceutical for public health crisis  response, under 
the Medical Device Act, shall request the Minister of Food and Drug Safety to use the 
materials submitted to obtain permission for review the medical device to grant marketing 
approval item by getting consent for said pharmaceutical from t he person who has 
obtained the permission for pharmaceutical (Article 14 of the proposal).  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  To effectively handle public health crisis by ensuring access to effective car e 
and treatment for the patients who have suffered from critical illness through the 
promotion and support of development and by designating the pharmaceuticals which 
counteract public health crisis as public health crisis response medical product.; Protec tion 
of human health or safety  
8. Relevant documents:   
The National Assembly Bill No.2100166 (4 June 2020)  
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:   
Korea WTO TBT Enquiry Point  
Technical Barriers to Trade (TBT) Division  
Korean Agency for Technology and Standards (KATS)  
93 Isu -ro Maengdong -myeon Eumseong -gun 
Chungchungbuk -do  
27737  
+(82) 43 870 5525  
+(82) 43 870 5682 (Fax)  
tbt@korea.kr  
http://www.knowtbt.kr  
https://members.wto.org/crnattachments/2020/TBT/KOR/20_6263_00_x.pdf