G/TBT/N/KOR/927  
21 October 2020  
(20-7276) Page: 1/3 
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, Quasi -drug 
5. Title, number of pages and language(s) of the notified document:  The draft 
regulation of "Special bill on emergency use and development support of p ublic health 
response medical product such as infectious diseases" (23 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 "Special bill on emergency use and  development 
support of public health response medical product such as infectious diseases". The main 
contents  are: 
 1) Designation system of public health crisis response medical product such as infectious 
disease shall be introduced in order to respond t he diseases caused by the use of 
infectious disease and biochemical weapons. Materials to be submitted, designation 
requirements and designation procedures for designation application shall be specified 
(Article 5 of Draft).  
 2) The bill allows the person who intends to develop public health crisis response medical 
product such as infectious disease to provide necessary technical support, human 
resources, international cooperation, and clinical trial (Article 6 and 7 of Draft).  
 3) In order to shorte n the review period for product license of public health crisis response 
medical products, the results of clinical trials shall be submitted for each development 
process and they shall be reviewed in advance (Article 8 of Draft).  G/TBT/N/KOR/927  
 
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   4) The review for the med ical products shall be prioritized where the product license for 
the public health crisis response medical products such as infectious disease is applied 
(Draft Article 9).  
 5) The manufacturing/marketing product license may be granted with one more 
condit ions such as submission of additional clinical trial data where 
manufacturing/marketing product license for public health crisis response medical 
products such as an infectious disease is applied (Article 10 of Draft).  
 6) It deems that public health crisi s response medical product such as infectious disease 
that have been granted conditional manufacturing/marketing product license is 
designated as national essential drug (Draft Article 11).  
 7) The Minister of Food and Drug Safety shall evaluate matters su ch as the impact on 
the treatment of patient, safety and efficacy and publish the result of them on the web 
site where the manufacturing/marketing product license for public health crisis response 
medical product such as infectious disease is granted (Arti cle 12 of Draft).  
 8) A person who has obtained manufacturing/marketing product license for public health 
crisis response medical product such as said infectious disease shall carry out 
investigation on safety measure and medical product use -results and re port the result to 
the Minister of Food and Drug Safety (Article 13 of Draft).  
 9) A person who has obtained manufacturing/marketing product license for public health 
crisis response medical product such as infectious disease may pursue the treatment 
suppo rt project including providing medicines for free with those who are in need of them 
(Article 14 of Draft).  
 10) The Minister of Food and Drug Safety may grant permission for the manufacturing 
and importing of unapproved medical product or importing of the  medicines in the 
overseas development without clinical trial approval in Korea to respond the public health 
crisis as the request of head of the central administrative agency and the Minister of 
Health and Welfare may request the Minister of Food and Drug  Safety to extend the 
expiration date of the medicine stockpile (Article 15 of Draft).  
 11) The manufacturer or importer of medicine may apply emergency special permission 
to the Minister of Food and Drug Safety in order to promptly respond to national 
emergencies such as the spread of diseases that may seriously affect the lives and health 
of people. The Minister may grant restrictive approval where the Minister deems that the 
submitted materials are appropriate after deliberation by the Central Pharmaceut ical 
Affairs Council under the submission of data (Article 16 of Draft).  
 12) The Minister of Food and Drug Safety may grant the unapproved medical devices to 
be manufactured, imported, stored and displayed as the request of the head of the 
relevant centra l governmental agency in order to appropriately respond to national 
emergencies (Article 17 of Draft).  
 13) The materials submitted to receive the public health crisis response medical product 
such as infectious disease may be requested the Minister of Foo d and Drug Safety to be 
used for the said medical device review where a permission for a medical device that is 
combined with public health crisis response medical product such as infectious disease is 
granted (Article 19 of Draft).  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  To provide necessary technical support, human resources, international 
cooperation by designating public health crisis response medical product such as 
infectious disease and expedite pro duct development and permission based on situational 
frequent review, priority review and conditional product license. Additionally, to protect 
lives and safety of people and alleviate public health crisis by promptly responding to 
public health crisis sit uation such as infectious disease based on preparation of grounds 
to support urgent production and import orders, restrictive license and similar articles in 
addition to pharmaceuticals and medical devices.; Protection of human health or safety  
8. Relevan t documents:   
The National Assembly Bill No.2101921 (14 July 2020)  G/TBT/N/KOR/927  
 
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  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 Standar ds (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_6262_00_x.pdf