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 (http://www.mfds.go.kr)

Also available from: 

International Cooperation Office

Ministry of Food and Drug Safety

187 Osongsaengmyeong2-ro, Osong-eup

Heungdoek-guCheongju-si

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): Biological products

5.

Title, number of pages and language(s) of the notified document: Proposed amendments to the "Regulation of Review and Authorization on Biological Products, etc." (14 pages, in Korean)

6.

Description of content:

·                Expand the definition of biobetters to include biological products with changes in the active ingredient content or dosage/administration

·                Delete the exemption clause for recombinant protein products for export, which would invalidate its submission of GMP records with at least one manufacturing unit when evaluating GMP (they would be subject to submitting records with at least three manufacturing units)

·                Require stem-cell products to be subject to long-term safety evaluation to enhance active monitoring of adverse events and strengthen post-marketing safety management

7.

Objective and rationale, including the nature of urgent problems where applicable: Protection of consumer health

8.

Relevant documents: MFDS Notification No. 2015-284 (28 August 2015)

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:

WTO 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 5525

Fax: (+82) 43 870 5682

E-mail: tbt@kats.go.kr

Website: http://www.knowtbt.kr