G/TBT/N/KOR/926  
21 October 2020  
(20-7274) Page: 1/4 
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, Medical devices  
5. Title, number of pages and language(s) of the notified document:  Act on Special 
Cases Concerning Promoting the Development of Public Healt h Crisis Response Medical 
Products and Supplying Medical Products for Emergency Response (38 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 Spec ial Cases Concerning Promoting the 
Development of Public Health Crisis Response Medical Products and Supplying Medical 
Products for Emergency Response". The main contents  are: 
1) Introduction of designation system for public health crisis response medical products 
(Article 6 of Draft)  
  Designation system for public health crisis response medical product shall be 
introduced to promptly support rapid development of public health crisis response 
medical products and materials to be submitted, designat ion requirements and 
designation procedures for designation application shall be specified.  
2)  Priority review system of public health crisis response medical products (Article 7 of 
Draft)  
  Rapid availability of public health crisis response medical pro ducts shall be ensured by 
prioritizing investigation for the medical products where the product license for the 
public health crisis response medical products is applied or permission for clinical trial 
investigation protocol is applied.  G/TBT/N/KOR/926  
 
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  3)  Situational f requent review for public health crisis response medical products (Article 
8 of Draft)  
  In order to shorten the review period for product license of public health crisis 
response medical products, the results of clinical trials shall be submitted for eac h 
development process and they shall be reviewed in advance.  
4) Conditional product license for public health crisis response medical products (Article 
9 of Draft)  
  For the application for the product license of product license of public health crisis 
response medical products, the requirements for the application shall be replaced with 
other ones or streamlined, but conditional product license shall be conducted where the 
clinical trials for the humans cannot be performed due to ethical reasons or the 
medicine whose navigational clinical trial format (phase 2) and purpose are similar to 
therapeutic validation clinical trials (phase 3).  
5)  Safety measures for public health crisis response medical products (Article 11 of 
Draft)  
  A person who has obtained  the product license for public health crisis response 
medical products shall carry out safety measure and medical product use -results 
surveillance and report them. The Minister of Food and Drug Safety may order 
additional measures related to safety use, i f necessary, based on the report results.  
6) Adverse event reporting system of public health crisis response medical products 
(Article 12 of Draft)  
  If a person who has obtained the product license for public health crisis response 
medical products recog nizes the examples of safety and efficacy, he/she shall report it 
to the president of Korea Institute of Drug Safety and Risk Management (KIDS). The 
Minister of Food and Drug Safety who was reported about the analysis result from the 
president of KIDS shal l determine whether to continue to use the medical product where 
it deems that there is serious risk on it.  
7) Tracking investigation and usage history registration of public health crisis response 
medical products (Article 13 of Draft)  
  If it is recogni zed that it is necessary to confirm whether adverse event occur over a 
certain period after the use of public health crisis response medical products, it may be 
designated for tracking investigation and performed it, and necessary measures for 
public healt h may be taken according to the result of the investigation.  
8) Support project for the use of public health crisis response medical products (Article 
14 of the draft)  
  A person who has obtained product license of public health crisis response medical 
products may pursue the project including providing medical products for free with 
those who are in need of them.  
9) Support development of public health crisis response medical products (Articles 16 to 
18 of Draft)  
  For the person who intends to develop public health crisis response medical products, 
technical support, international cooperation support, clinical trials shall be provided.  
10) Special cases concerning public health crisis (Article 19 of Draft)  
  The Minister of Food and Drug Safety may gra nt permission for the manufacturing and 
importing of unapproved medical product or importing of the overseas medical product 
development without clinical trial approval in Korea to respond the public health crisis as 
the request of head of the central admi nistrative agency.  
11) Extension of expiration date of national medicine stockpile (Article 20 of Draft)  
  The head of the central administrative agency may request the Minister of the Food 
and Drug Safety to extend expiration date of national medicine st ockpile where the 
head deems that it is necessary to extend the expiration date of the medicine stockpile 
or quasi -drugs in accordance with legislation concerned.  
12) Issuance command on urgent production and import of permitted medical products 
(Article 2 1 of Draft)  
  The Minister of Food and Drug Safety may issue a command on production adjustment 
and import control and import control of permitted medical products during the public 
health crisis. Furthermore, the Minister may request the head of the centr al G/TBT/N/KOR/926  
 
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  administrative agency to take necessary measure where it is necessary to have 
consultation between countries caused by shortage of raw materials countries.  
13) Distribution management of medical products (Article 22 of Draft)  
  The Minister of Food and  Drug Safety may take measure including designation of 
distributor and setting market condition of medical products in the event of public health 
crisis, if necessary, the Minister may request the head of the central administrative 
agency to cooperate.  
14) Construction of information system for public health crisis response medical products 
(Article 23 of draft)  
  The Minister of Food and Drug Safety may build and operate information system related 
to supply management of medical products in order to effici ently promote distribution 
management.  
15) Conducting field survey for Public Health Crisis Response Medical Products (Article 
25 of Draft)  
  The Minister of Food and Drug Safety may investigate manufacturing, importing and 
utilization of Public Health Cri sis Response Medical Product in order to ensure the quality 
and safety of public health crisis response medical products and may request the person 
who has obtained the product license of the said product to submit the relevant data 
and give his/her opinio n. 
16) Preparation of ground for cancellation of manufacturing approval and suspension of 
business (Article 26 of Draft)  
  If a person who has obtained product license for Public Health Crisis Response Medical 
Product violates the obligation stipulated by this Act, the established ground allows to 
revoke the product license for the medical product or order the suspension of 
manufacturing, importing, and marketing within a year.  
17) Preparation of ground for fine disposition (Article 27 of Draft)  
  The esta blished ground which allows to impose a fine of 1 billion won substituting for 
disposition of business suspension where there is concern that it is likely to 
inconvenience the person who uses Public Health Crisis Response Medical Product and 
harm public in terest according to Article 26.  
18) Preparation of ground for penalty (from Articles 30 to 32 of Draft)  
  The established ground allows to punish the person who violated the Act including the 
person who has obtained the product license for the Public Heal th Crisis Response 
Medical Product by false or other illegal methods according to the penal regulations.  
19) Preparation of grounds for fines (Article 34 of Draft)  
  The established ground allows to punish the person who breached the reporting and 
registr ation obligation including the person who has not reported the results of 
investigations such as safety measure.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  To promote quick development of medical product by establishing 
designation, priority review, situational frequent review, conditional product review for 
public health crisis response medical product. Additionally, to preemptively respond the 
public healt h crisis and protect lives and safety of people by constructing system which 
provides emergency supply of medicines in need for public health crisis such as urgent 
production and import orders and distribution management.; Protection of human health 
or saf ety 
8. Relevant documents:   
The National Assembly Bill No.2101732 (9 July 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  G/TBT/N/KOR/926  
 
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  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_6261_00_x.pdf