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) 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 language(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·                Streamline the approval process for imported pharmaceuticals that have previously withdrawn their domestic approval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.

·                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 for 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 posology/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 orphan 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 addresses, 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

http://members.wto.org/crnattachments/2014/tbt/kor/14_2371_00_x.pdf