G/TBT/N/JPN/905

30 March 2026

(26-2502)

Committee on Technical Barriers to Trade

Original: English

2.

Agency responsible:

Ministry of Health, Labour and Welfare

3.

Notified under Article 2.9.2 [X], 2.10.1 [ ], 5.6.2 [ ], 5.7.1 [ ], 3.2 [ ], 7.2 [ ], Other:

4.

Products covered (HS codes or national tariff lines. ICS numbers may be provided in addition, where applicable): Pharmaceutical products (HS: 30)

5.

Details of notified document(s) (title, number of pages and languages, means of access): Partial amendment to the Minimum Requirements for Biological Products

Partial amendment to the Public Notice on National Release Testing; (1 page(s), in English)

Link to notified document(s) and/or contact details for agency or authority which can provide copies upon request:

https://members.wto.org/crnattachments/2026/TBT/JPN/26_01748_00_e.pdf

Japan Enquiry Point

International Trade Division,

Economic Affairs Bureau,

Ministry of Foreign Affairs

Fax: (+81 3) 5501 8343

E-mail: enquiry@mofa.go.jp

6.

Description of content: The Minimum Requirements for Biological Products will be amended as follows:

The standard for "Freeze-dried Live Attenuated Measles, Mumps, Rubella Combined Vaccine" that is to be newly approved will be added.

The Public Notice on National Release Testing will be amended as follows:

The criterion, fee, quantity and Institution for National Release Testing for "Freeze-dried Live Attenuated Measles, Mumps, Rubella Combined Vaccine" that is to be newly approved will be added.

7.

Objective and rationale, including the nature of urgent problems where applicable: To establish the standard for manufacturing process, properties, quality, storage, and others of pharmaceuticals to which special attention must be paid for the attainment of public health and sanitation (Biological products). In addition, to stipulate the pharmaceuticals to which special attention must be paid for the attainment of public health and sanitation as subject to National Release Testing, as well as fee, criterion, quantity and institution for the testing.

8.

Relevant documents:

Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices.

https://www.japaneselawtranslation.go.jp/en/laws/view/3213

This amendment will be published in "KAMPO" (Official Gazette) when adopted.

Relevant notifications:

• G/TBT/N/JPN/900

9.

Proposed date of adoption: May 2026

Proposed date of entry into force: May 2026

10.

Provision of comments

Final date for comments: 29 April 2026 (30 days from notification)

[ ] 60 days from notification

Contact details of agency or authority designated to handle comments regarding the notification:

Japan Enquiry Point

International Trade Division,

Economic Affairs Bureau,

Ministry of Foreign Affairs

Fax: (+81 3) 5501 8343

E-mail: enquiry@mofa.go.jp