G/TBT/N/KOR/929  
21 October 2020  
(20-7277) 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  
5. Title, number of pages and language(s) of the notified document:  A draft 
regulation of "Bill on public health response medical product and innovative new drug 
development support" (24 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 "Bill on public health response medical product 
and innovative new drug developme nt support". The main contents  are: 
1) The purpose is to promote the development and supply of pharmaceutical for public 
health crisis response and new medicines, ultimately, to protect the health of the people 
and to contribute to the improvement of the q uality of life in order to lead reinforced 
public nature and innovation growth in the pharmaceutical industry (Article 1 of the 
Proposal).  
2) Republic of Korea shall endeavour to ensure smooth supply of said pharmaceutical by 
supporting and promoting the development of pharmaceutical for public health crisis 
response and new drug. The Minister of Food and Drug Safety shall take measures such 
as establishing a relevant system and training human resources in order to develop a 
method which faci litate quick prediction, evaluation and judgement quality, safety and 
efficacy of pharmaceutical for public health crisis response and new medicine (Article 3 of 
the Proposal).  
3) The Safety Management Committee for pharmaceutical for public health crisis response 
and new drug shall be established under the Ministry of Food and Drug Safety to deliberate 
and consult the development of safety control systems and systems, development support G/TBT/N/KOR/929  
 
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  and promotion, designation and cancellation of designation, approval and cancellation of 
approval and transfer and acquisition of approval for pharmaceutical for public health 
crisis response (Article 5 of the Proposed).  
4) Designation system for pharmaceutical for public health crisis response or new 
medicine will be intro duced by creating designation requirements and process for the 
pharmaceutical and the innovative new drug that can be provided administrative support 
such as simplification of document submission for preemptive review, application approval 
and frequent acc ompanying review (Article 6 and 7 of the proposal).  
5) The Minister of Food and Drug Safety shall provide administrative support, such as 
preemptive review and frequent accompanying review where an application for approval 
is filed for the designated pharm aceutical for public health crisis response or new drug 
(Article 8 and 9 of the proposal).  
6) For the innovative medicine whose forms and purpose of the therapeutic search clinical 
trials are similar to those of therapeutic confirmation clinical trials amo ng pharmaceuticals 
and innovative new drug that cannot be conducted clinical trials for human due to ethical 
reasons of pharmaceutical for public health crisis response or new drug (Articles 10 and 
11), submission documents for application for approval sha ll be replaced with another 
ones and simplified.  
7) Where Minister of Food and Drug Safety gives product approval for pharmaceutical for 
public health crisis response or innovative new drug, he/she shall evaluate the impact of 
the drug on patient treatment  and the comprehensive therapeutic value by taking into 
account the safety and efficacy of the drug and publish it on the Internet website (Article 
12 of the proposal).  
8) The Minister of Food and Drug Safety shall provide the developers with relevant 
dome stic and international information or support international exchange and joint 
international research to cooperate with international organizations, who promote the 
development of pharmaceutical for public health crisis response or innovative new drug 
(Article 14 of the Proposal).  
9) Where a person who has been designated as pharmaceutical for public health crisis 
response or innovative new drug intends to conduct a clinical trial for said pharmaceutical, 
Minister of Food and Drug Safety shall support prepa ration of a clinical trial plan, 
recruitment of clinical trial participants, training for persons engaged in clinical trials and 
the implementation of international joint clinical trials (Section 15).  
10) A person who has obtained a product approval for ph armaceutical for public health 
crisis response are required to conduct a survey on the safety use and the results of use 
of the drug and quarterly report it to the Minister of Food and Drug Safety. The minister 
may order additional measures for safe use fo llowing the review of the report, if these 
measures are not implemented, the minister my order to recall and abandon the drug 
(Article 16 of the proposal).  
11) It enables a person who has obtained a product approval for pharmaceutical for public 
health cri sis response or innovative new drug to support the patient treatment such as 
providing the patient with pharmaceutical free of charge, if necessary, request the 
Minister of Food and Drug Safety to support it (Article 17 of the proposal).  
12) Where the medi cal device combined with pharmaceutical for public health crisis 
response or innovative new drug or approval is required in accordance with Medical Device 
Act as it falls within the medical device for diagnosing the indication of pharmaceutical for 
public health crisis response or innovative new drug, under this Act, the submitted 
documents to obtain product approval for pharmaceutical for public health crisis response 
or innovative new drug shall be utilized for the purpose of approval of medical device 
(Article 18 of the proposal).  
13) It enables a person who has obtained a product approval for pharmaceutical for public 
health crisis response or innovative new drug, importer, wholesaler, medical institution 
organizer to report the adverse events, which sus pected of said pharmaceutical, such as 
illness, disability and death, to the director of the Korea Institute of Drug Safety & Risk 
Management and the director shall it to Minister of Food and Drug Safety (Article 19 of 
the proposal).  G/TBT/N/KOR/929  
 
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  14) Transfer and acqui sition for pharmaceutical for public health crisis response or 
innovative new drug shall be deliberated by the Safety Committee on pharmaceutical for 
public health crisis response and new drug (Article 20 of the proposal).  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  To invest a certain size of budget on public health crisis response medical 
product to be used the diseases caused by the use of infectious disease, biochemical 
weapons and nuclear materi als and new drug development and create regulation to lead 
innovative growth by developing global novel drug based on designation of new drug, 
priority review, situational frequent review and simplification of requirements for the new 
drugs developed by in novative pharmaceutical companies with business ethics and social 
responsibility.; Protection of human health or safety  
8. Relevant documents:   
The National Assembly Bill No.2100788 (19 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_6264_00_x.pdf