G/TBT/N/KOR/482  
 
7 March 2014  
(14-1378)  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, Ch eongwon-gun, Chungcheongbuk-do, 363-
700 
Republic of Korea   Tel: (+82) 43719-1564 
Fax: (+82) 43-719-1550 
Email: wtokfda@korea.kr  
3. Notified under Article 2.9.2 [   ], 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:  Revised decree 
of the Regulation on Safety of Pharmaceuticals,  etc. (86 pages, available in Korean)     G/TBT/N/KOR/482 
 
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  6. Description of content:  The following revisions have been made: 
- Establish new GMP regulations appropriate for active pharmaceutical ingredients 
(APIs) and investigational medicinal products (IMPs) with a view to strengthening 
pharmaceutical safety through the international harmonization of GMP; 
- Establish new GMP regulations appropriate for radiopharmaceuticals and medicinal 
gases, taking into account their pharmaceutical characteristics, and mandate that 
manufacturers comply with the new regulations; 
- Mandate that manufactures perform validation on non-sterile herbal medicinal 
products; 
- Require manufacturers and importers of orphan drugs, pharmaceutical reference-
standards used in manufacture, radiopharmaceuticals, and medicinal gases to submit evaluation data regarding GMP implementation status when applying for approval of manufacturing, distribution and/or import of the above-mentioned 
products; 
- Notify the results of the safety and efficacy assessment upon completion, even at 
the pre-approval stage, to the President of the Health Insurance Review & 
Assessment Service and the applicant for drug approval in the interest of enabling 
the prompt evaluation of reimbursement pr icing, facilitating market entry of new 
drugs, etc.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:   
- Protection of consumers and promotion of public health; 
- To strengthen safety and quality control of pharmaceutical products through 
 international harmonization of GMP for accession to PIC/S; 
- To facilitate market entry of pharmaceutical products through prompt evaluations 
 of reimbursement pricing. 
8. Relevant documents:   MFDS NOTIFICATION No. 2014-45   
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 the 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 
Republic 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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