G/TBT/N/KOR/1183  
8 December 2023  
(23-8347) 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:   
Documents are available from the Ministry of Food and Drug safety website 
(www.mfds.go.kr). Also available from:  
International Cooperation Office  
Ministry of Food and Drug Safety (MFDS)  
187 Osongsaengmyeong2 -ro, Osong -eup, Heungdoek -gu Cheongju -si, Chungch eongbuk -
do, 28159  
Republic of Korea  
Tel: (+82) 43 719 -1564 
Fax: (+82) 43 -719-1550 
Email: intmfds@korea.kr  
3. Notified under Article 2.9.2 [X], 2.10.1 [  ], 5.6.2 [X], 5.7.1 [  ], 3.2 [  ], 7.2 [  ], 
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:  Proposed 
amendments to the "Regulations on Safety of Pharmaceuticals, etc."; (31 page(s), in 
Korean)  
6. Description of content:  The Ministry of Food and Drug Safety (MFDS) is proposing to 
amend the "Regulations on Safety of Pharmaceuticals, etc." as follows:  
A. Improvement of regulations related to submission for Marketing Authorization (revision 
of Article 4 of the regulation)  
In the case of contracted manufacturing during the entire process, submission of 
evaluation data for GMP will be exempted, and in the case of national essential medicine 
for which there are no alternatives, some of the submission can be replaced with a letter 
of explanation when applying for authorization, allowing to implement rapid approval and 
minimize gaps in treatment for Korean patients.  
B. Clarification of submission for approval of IND (revision of Article 24 of the regulation, 
Form No. 23)  G/TBT/N/KOR/1183  
 
- 2 - 
 
  When approving investigational new drug (IND) application, it was clearly stated so that 
the data necessary to be evaluated whether the investigational drug complies with GMP 
and GCP can be submitted.  
C. Improvement of report on drug shortages (revision of Article 49 of the regulation, 
Appendix 8 II. No. 27)  
The deadline for reporting on drug shortages will be set to 180 days in advance, and even 
in the case of shortages, it will be required to be reported so that the government can 
proactively respond to the shortages, t he standards for administrative dispositions in case 
of non -reporting will be strengthened to increase the effectiveness of the report.  
D. Improvement of procedures related to items in the patent list (revision of Article 62 -4 
and Article 62 -11 of the regu lation, new establishment of Form No. 59 -8) 
When changing matters listed in the patent list, minor matters that do not require a 
procedure to have public consultation from stakeholders will be regulated and documents 
and procedures to be submitted when rep orting the occurrence of reasons for the 
expiration of prior marketing approval will prepared.  
E. Modification of administrative dispositions related to safety management personnel 
(Revision of [Appendix 8] of the regulation, II. No. 23, 29)  
In cases where  a safety management manager is not appointed and when changes or 
cancellations are not reported, the disposal standard has been modified into suspension 
of marketing business.  
F. Reorganization of forms related to determination of compliance with GMP (revision of 
forms No. 81, 81 -2, and 82)  
Forms on determination of compliance with GMP will be reorganized to include detailed 
dosage forms determined by the Minister of Food and Drug Safety.  
7. Objective and rationale, including the nature of urgent prob lems where 
applicable:  To complement the shortcomings of the current operating system  
8. Relevant documents:   
MFDS NOTIFICATION No. 2023 -550, 29 November 2023  
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 [ ] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
Technical Barriers to Trade(TBT) Division  
Korean Agency for Technology and Standards (KATS)  
93, Isu -ro, Maengdong -myeon, Eumseong -gun, Chungcheongbuk -do, Republic of Korea, 
369-811 
Tel.: (+82) 43 870 5315 Fax: (+82) 43 870 5682  
E-mail: tbt@ka ts.go.kr  Website: http://www.knowtbt.kr  
https://members.wto.org/crnattachments/2023/TBT/KOR/23_14120_00_x.pdf