G/TBT/N/KOR/490  
 
19 May 2014  
(14-3025)  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 telephon e 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 Food and Drug Safety website 
(http://www.mfds.go.kr ). Also available from: 
International Cooperation Office 
Ministry of Food and Drug Safety 187 Osongsaengmyeong2-ro, Osong-eup, Cheongwon-gun, 
Chungcheongbuk-do, 363-700 
Republic of Korea Tel: (+82) 43 719-1564 
Fax: (+82) 43-719-1550 
Email: wtokfda@korea.kr  
3. Notified under Article 2.9.2 [ X ], 2.10.1 [   ], 5.6.2 [ X ], 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 langua ge(s) of the notified document: Proposed 
amendment of the "Regulation on Pharmaceuticals Approval, Notification and Review" (47 
pages, in Korean) 
6. Description of content: 
 Preparations that can be taken without water (orally disintegrating tablets) are 
taken from the category "special preparations" and moved to "general 
preparations". 
 Establish standards for the evaluation of safety and efficacy of preparations 
administered through the inhalation of active drug substances, etc., so that they 
are internationally harmonized. 
 Improve the management of approval for active drug substances with different 
hydrates that function equally in the human body. 
 Exclude ester derivatives of already approved drug substances from the "new 
molecular entity" category if it is identical to an approved drug when orally taken 
and degraded in the digestive organs. 
 Streamline the approval process for imported pharmaceuticals that have 
previously withdrawn their domestic approval  
 Acknowledge multiple specifications for an active substance in case of 
pharmacopoeia specification. 
 Mandate GMP evaluation in the approval process of pharmaceuticals intended for 
export. G/TBT/N/KOR/490 
 
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   Allow a separate approval process for pharmaceuticals intended for export. 
 Rationalize the domestic approval process for foreign new drugs by improving the 
scheme in deciding whether to perform bridging studies. 
 Abolish mandatory notification of drug substance's specification in the certificate, 
which verifies the imported drugs' certification for manufacture and marketing in the originating country. 
 Mandate the submission of CTD fo r approval for generic drugs. 
 Mandate the submission of data that proves the non-addition of harmful 
substances that originated from the container. 
 Strengthen safety management regulations for manufacturing processes of 
animal-derived pharmaceuticals. 
 In addition to bioequivalence study, secure a method to ensure credibility of 
pharmacokinetics data(Audit-trail) of phase 1 clinical trial 
 Mandate stability test report submission of generic drugs. 
 Improve the display/presentation of po sology/method of administration for 
paediatric drugs. 
 Introduce a method to provide professional approval information for experts 
(doctors, pharmacists, etc). 
 Provide 4-year exclusivity for pediatric drugs with added new indication or 
posology/method of administration and or phan drugs whose efficacy and safety 
have been verified by domestic clinical trials. 
 Mandate the submission of verification data on microorganism specification in 
approval processes of probiotics. 
 Strengthen quality evaluation of subdivided pharmaceutical ingredients. 
7. Objective and rationale, including the nature of urgent problems where 
applicable: 
 To improve global competitiveness and integrity of Korean pharmaceuticals 
through the administration of a separate approval process for pharmaceuticals 
intended only for export, harmonization of safety data requirements for multiple 
preparations, and rationalize the requirements for manufacture and marketing certification of imported pharmaceuticals, and mandate the submission of internationally-common technology documents, and strengthen safety evaluation 
for generic drugs. 
 To strengthen the basis of consumers' safe use of pharmaceuticals and enhance 
inadequate aspects by presenting the direction and dose of drugs for children in a 
way that is easily-understandable table, establishing the basis for providing 
professional information for experts, etc. 
8. Relevant documents:  MFDS NOTIFICATION No. 2014-115 (30 April 2014) 
9. Proposed date of adoption:   
Proposed date of entry into force:    To be determined To be determined 
10. Final date for comments: 60 days from date of notification 
11. Text available from:  National enquiry point [X], or address, telephone and fax 
numbers, e-mail and web-site addresse s, if available of the other body:  
Technical Barriers to Trade (TBT) Division 
Korean Agency for Technology and Standards (KATS) 
96 Gyoyukwongil, Gwacheon-si, Gyeonggi-do, Rep. of  Korea 427-716 
Tel.:  (+82) 2 509 7254/7255  Fax:  (+82) 2 509 7307 
E-mail:  tbt@kats.go.kr  
Website:  http://www.knowtbt.kr  
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