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WTO notification · TBT

South KoreaProposed measure, not in force yet

Pharmaceutical products – South Korea

Official title

Partial amendment to the 'Regulation for Pharmaceutical Approvals, Notifications and Reviews'

South Korea notified this proposed TBT measure to the WTO on 29 June 2026. The comment period closed on 28 August 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, not in force yet
Objectives
  • Other
Area
TBT: Technical product rulesTechnical barriers to trade
Notification type
Regular notification
Document symbol
G/TBT/N/KOR/1358
ICS classification
  • 11.120 Pharmaceutics

Key dates

Distributed by the WTO
Comment deadline
Closed on 28 August 2026
Proposed adoption
To be determined
Proposed entry into force
To be determined

How to comment

The comment period closed on 28 August 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/1358; 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 of the Republic of Korea intends to amend the following provisions of the 'Regulation for Pharmaceutical Approvals, Notifications and Reviews' A. If only the name of the 'general test method' registered in the Korean Pharmacopeia or other official compendia notified by the Minister of Food and Drug Safety is changed, such change will be deemed to have been approved or notified. (Article 3-2) B. A legal basis will be established to allow the stability data for medical high-pressure gases to be substituted by evidence from prior use of previously approved or notified products. (Article 7) C. Provisions related to the Risk Management Plan (RMP) will be aligned with the amendment of higher-level legislation. (Article 7-2) D. Eligibility for multiple specifications for an active ingredient will be expanded to include orphan drugs for which quality-related data have been submitted. (Article 12) E. When obtaining approval for a new dosage form of an OTC drug with same route of administration, eligibility for reduced data requirements will be clarified by specifying what constitutes minor differences from previously approved/notified dosage forms. (Annex 1)

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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