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WTO notification · TBT

South KoreaProposed measure, not in force yet

Proposed amendment to the Regulation on Safety

Official title

Proposed amendment to the Regulation on Safety of Pharmaceuticals, etc.

South Korea notified this proposed TBT measure to the WTO on 26 August 2026. The comment period closed on 25 October 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/1377

Key dates

Distributed by the WTO
Comment deadline
Closed on 25 October 2026
Proposed adoption
To be determined
Proposed entry into force
To be determined

How to comment

The comment period closed on 25 October 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/1377; 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

A. Allowing notification of address changes due to administrative district reorganization (Article 8, 24, 35, 37) Where an address change results from administrative district reorganization, the procedures are simplified as follows: - for pharmaceutical manufacturers, importers and contract manufacturing and sales business operators, the change may be notified instead of obtaining approval - for approved clinical trial protocols, the change may be notified instead of obtaining approval - for clinical sample analysis institutions and non-clinical testing institutions, the change may be notified instead of applying for a change in designation B. Adjusting the deadline for submitting recall plans for marketed pharmaceuticals(Article 50) If pharmaceuticals being marketed in Korea have safety and efficacy issues, the deadline for submitting a recall plan is adjusted. C. Prohibiting AI-generated advertisements falsely implying endorsement or recommendation by medical professionals AI-generated advertisements that may mislead consumers into believing that medical professionals endorse or recommend medical products are prohibited.'(Article 78 and Annex 7) D. Revising GMP for investigational products (Annex 4-2) Good Manufacturing Practice for investigational products is revised to align with international standards E. Reducing the processing period of Investigational New Drug Applications (Change)(Annexed Form No. 23) If an IND application is found to be compliant in the pre-review…

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

    New tailored certification audit types (D, E, and G types) and procedures are newly introduced, and specific audit criteria for each type are established to accommodate various industrial environments, such as entities without manufacturing facilities (Article 13, Annex 7-2, Annex 8, and Annex 9).

    No products listed by the notifying member

    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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