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 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) 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 language(s) of the notified document: Revised Decree of the "Regulation on Safety of Pharmaceuticals" (29 pages, in Korean)

6.

Description of content:

·                Newly establish that pharmaceutical manufacturing sites must be in conformity with manufacturing and quality control standards. They will be issued with a certificate (from the Minister of MFDS or, Commissioners of Regional KFDA) that confirms the above, which is valid for 3 years. When manufacturing sites with a valid certificate apply for drug approval, the certificate may replace evaluation data on pharmaceutical manufacturing and quality control.

·                Revise that when drugs under National Batch Release are used as drug substance to manufacture pharmaceutical products, the quality evaluation process may be streamlined. If examination result reports from the manufacturer, and a document which certifies that the drug is under National Batch Release are submitted, only verification tests and visual inspection may be conducted.

·                Newly establish regulations that provide the basis for an administrative measure when those with drug approval and importers do not comply with Good Supply Practice.

7.

Objective and rationale, including the nature of urgent problems where applicable: Protection of human health or safety

·         To mitigate burden on companies by ensuring the distribution and manufacture of safe pharmaceutical products through strengthened quality control and streamlining of approval process.

·         To mitigate burden on companies by streamlining the quality evaluation process when drugs under National Batch Release are used as drug substance.

·         To secure the safety and quality of pharmaceutical products by imposing administrative measures when requirements of Good Supply Practice are not met.

8.

Relevant documents: MFDS NOTIFICATION No. 2014-114 (7 May 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 addresses, if available of the other body:

Technical Barriers to Trade (TBT) Division

Korean Agency for Technology and Standards (KATS)

98 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

http://members.wto.org/crnattachments/2014/tbt/kor/14_2374_00_x.pdf