G/TBT/N/KOR/1172  
4 October 2023  
(23-6648) 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  
187 Osongsaengmyeong2 -ro, Osong -eup, Heungdoek -gu Cheongju -si, Chungcheongbuk -
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 [  ], 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:  Amendments to 
the "Regulation for Pharmaceutical Approvals, Notifications and Reviews" ; (36 pages, 
available in Korean)  
6. Description of content:  The Ministry of Food and Drug Safety (MFDS) is proposing to 
amend the "Regulation for Pharmaceutical Approvals, Notifications and Reviews" as 
follows:  
A It will be allowed to use food raw materials in enteric nutritional supplements (Article 3 
of the Draft)  
B. Expansion of the scope of minor changes that do not require approval (Article 3 -2 of 
the Draft)  
C. Clarification of exemption from submis sion requirement of Certificate of Pharmaceutical 
Product (CPP), deletion of CPP for Common Technical Documents submission 
requirements (Articles 4, 6, and Annex 3 of the Draft)  
D. Clarification of approval review data requirements for synthetic peptide dr ug products 
(synthetic peptide) that refers to a previously approved peptide drug product of G/TBT/N/KOR/1172  
 
- 2 - 
 
  recombinant deoxyribonucleic acid(rDNA) origin(peptide of rDNA origin) (Articles 7, 27, 
and Appendix 1 of the Draft)  
E. Exemption from submission of genotoxicity t est data if there is no change in the 
manufacturing process as a drug product already used in Korea (Article 7 of the Draft)  
F. Acceptance of non -clinical data which utilized appropriate non -clinical data and 
alternative method instead of animal test as a result of on -site inspection for OECD 
member countries (Article 7 of the Draft)  
G. Expansion of the scope of Science Citation Index (SCI) into Science Citation Index 
Expanded (SCIE) (Articles 7 and 14 of the Draft)  
H. Establishment of submission standards details for 'Overview of Risk Management Plan' 
(newly established in Article 7 -2 of the Draft and Annex 6 -3) 
I. Expansion of the scope of recognition of multiple specifications for active 
pharmaceutical ingredients (API) of pharmaceuticals (Article 12 of t he Draft)  
J. Embodying description method of pharmaceuticals (Article 13 of the Draft)  
K. Application to MedDRA to specify precautionary information (Article 17 of the Draft)  
L. Update of safety and efficacy review standards for injections, ophthalmic solutions, and 
otic solutions(Articles 25 and 27 of the Draft)  
M. If a bioequivalence test is not possible or meaningless, it can be replaced with a 
scientifically valid test (Art icle 27 of the Draft)  
N. Update of standards for conducting bioequivalence tests for oral anticancer drugs, etc. 
(Article 27 of the Draft)  
O. Exemption from stability data in case of contract manufacture of entire process using 
the same manufacturing metho d (Article 28 of the Draft)  
P. Clarification of documents to be submitted for preliminary review (Newly established 
in Article 55 of the Draft and Annex 20)  
Q. Addition of National Essential Medicine (NEM) to expedited review categories (Article 
58 of the Draft)  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Consumer information, labelling  
8. Relevant documents:   
MFDS NOTIFICATION No. 2023 -474, 27 September 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@kats.go.kr  Website: http://www.knowtbt.kr  
https://members.wto.org/crnattachments/2023/TBT/KOR/23_12801_00_x.pdf