G/TBT/N/KOR/1088  
29 July 2022  
(22-5742) 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, 363 -700 
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:  The Korean 
Pharmacopoeia; (31 page(s), in Korean)  
6. Description of content:  The purpose of the revision is to secure pharmaceutical quality 
control based on achieved international harmonization of criteria/specification in 「Korean 
Pharmacopoeia 」, to improve some cr iteria/specifications and general tests to the latest 
scientific level with reflecting opinions from the pharmaceutical industries, ultimately, to 
advance criteria/specifications and circulate high quality pharmaceuticals.  
1. A term 'Rubber Closures for Aque ous Infusions' was changed into the term ' 
'Rubber Closures for injectable drug' in General Notice, General Requirements for 
Pharmaceutical Preparations and General Test and the subject of application of 
the test method was expanded. An international harmo nization for the test 
method including addition of performance test of the rubber closures and 
replacement of animal test by the biological reactivity test.  
2. A definition 'In principle, there should be no foreign substances in an ophthalmic 
solution.' and a  paragraph ''foreign insoluble matter test for Ophthalmic G/TBT/N/KOR/1088  
 
- 2 - 
 
  Suspension is not performed in the the General Requirements for Pharmaceutical 
Preparations.  
3. A test method for 9 items including herbal medicinal preparations such as Soyo 
Granule in Part 2 of any a rticle was revised.  
4. A term 'LOD(Limit of Detection) in items such as 5. Verification and 5.2. 
Quantitative test(lower concentration e,g, quantitative test for impurity) was 
deleted, test parameters including specificity, accuracy, precision was changed 
into parameters including specificity and LOD in an item, 5.4 Limit test (reference 
concentration close to the limit of quantitation) and an item 5.5. Limit test 
(reference concentration significantly higher than the limit of quantitation) was 
deleted in 'Gui deline of Validation of Analytical Procedures for Pharmaceuticals' in 
General Information.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  To compensate the inadequacies of the current operating system  
8. Relevant documents:   
MFDS Notification No. 2022 -343 (27 July 2022)  
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 
Tel: +(82) 43 870 5521  
Fax: +(82) 43 870 5682  
Email: tbt@korea.kr  
Website: http://www.knowtbt.kr  
https://members.wto.org/crnattachments/2022/TBT/KOR/22_5021_00_x.pdf