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WTO notification · TBT

South KoreaProposed measure, may since have been adopted

Proposed revision of the 'Korean Pharmacopoeia'

South Korea notified this proposed TBT measure to the WTO on 8 January 2026. The comment period closed on 9 March 2026.

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Source: WTO ePing (opens in a new tab). Summaries by Expodite, which is independent of the WTO.

Published here:

At a glance

Products

Pharmaceuticals

Notifying member
South Korea(Korea, Republic of)
Status
Proposed measure, may since have been adoptedNotified as a draft on 8 January 2026. Check WTO ePing or South Korea for its current status.
Objectives
  • Quality requirements
  • Harmonization
Area
TBT: Technical product rulesTechnical barriers to trade
Notification type
Regular notification
Document symbol
G/TBT/N/KOR/1337

Key dates

Distributed by the WTO
Comment deadline
Closed on 9 March 2026
Proposed adoption
To be determined
Proposed entry into force
To be determined

How to comment

The comment period closed on 9 March 2026. You can still raise concerns about the measure with your country's WTO TBT enquiry point, quoting the document symbol G/TBT/N/KOR/1337; it can take them up with South Korea.

Find your country's enquiry point on WTO ePing (opens in a new tab)

What the notification says

The Ministry of Food and Drug Safety (MFDS) of the Republic of Korea intends to revise the following provisions of the Korean Pharmacopoeia: To respond to changes in the international regulatory environment, the Korean Pharmacopoeia (KP) will be completely revised from the 12th to the 13th edition. This revision aims to ensure the distribution of quality-assured pharmaceuticals and secure competitive edge in global markets by reorganizing KP and harmonizing pharmaceutical standards and specifications internationally. A. Revisions based on international harmonization of Pharmacopoeia Discussion Group (PDG) (Appendix 1, 5 and 6 of the draft) Replacement of 'Korean Pharmacopoeia 12th edition' with 'Korean Pharmacopoeia 13th edition' in Article 1.1 of General Notices (Appendix 1 of the draft); Harmonization of two methods (mass variation test for uniformity of dosage units and disintegration test for suppositories and vaginal tablets) with PDG standards (Appendix 5 of the draft); Reflection of the latest revisions to the PDG guidelines for international harmonization (Appendix 6 of the draft) B. Revision of General Notices and General Requirements for Pharmaceutical Preparations of the Korean Pharmacopoeia (Appendix 1 and 2 of the draft) C. Corrections of errors and reorganization of test methods and terminology in Monographs and General Tests (Appendix 3, 4 and 5 of the draft) Partial amendments to 28 specifications including application of a common assay to drug substances…

Sources

Expodite writes its summary from the official record. The notification and the documents it notifies are on the WTO's own websites.

All updates from South Korea

  1. WTO notificationSPSProposed measure, open for comments

    Proposed amendments to Standards for Recognition of Temporary Standard and Specifications for Foods

    The Republic of Korea is proposing to amend the 'Standards for Recognition of Temporary Standard and Specifications for Foods'. The regulations on applying for temporary standards and specifications of new food ingredients, food additives, etc. have been improved as following; 1) Revisions…

    Symbol: G/SPS/N/KOR/855Comments until 5 January 2027

  2. WTO notificationTBTProposed measure, open for comments

    Draft Partial Amendment to the Enforcement Rule of the Industrial Standardizatoin Act

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    Symbol: G/TBT/N/KOR/1387Comments until 3 January 2027

  3. WTO notificationSPSProposed measure, open for comments

    Partial Amendment Notice (Draft) of Standards and Specifications for Health Functional Foods (Advance Notice No. 2026-513, 23 October 2026)

    The proposed amendments seek to: A. Strengthening common manufacturing standards for functional ingredients (Draft Articles 2.1.3 and 2.2.3) - Establish specifications for the use of mixed functional ingredients and other ingredients to prevent misuse and side effects and ensure safe intake by…

    Symbol: G/SPS/N/KOR/854Comments until 3 January 2027

  4. WTO notificationSPSProposed measure, open for comments

    Partial Amendment Notice (Draft) of Standards and Specifications for Health Functional Foods (Advance Notice No. 2026-512, 23 October 2026)

    The proposed amendments seek to: A. Reorganization of the structural framework of the Standards and Specifications for Health Functional Foods (Draft Articles I.2, I.3, I.4, I.5, II.1, II.2, II.3, II.4, II.6, and [Annex 4]) The provisions for 'Collection and Handling of Test Samples' were…

    Symbol: G/SPS/N/KOR/853Comments until 3 January 2027

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