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WTO notification · TBT

JapanProposed measure, not in force yet

Pharmaceutical products – Japan

Official title

Partial amendment to the Minimum Requirements for Biological Products

Japan notified this proposed TBT measure to the WTO on 9 September 2026. The comment period closed on 9 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

Pharmaceutical products (HS: 30)

HS codes
  • 30 · Pharmaceutical products
    • 30
Notifying member
Japan
Status
Proposed measure, not in force yet
Objectives
  • Protection of human health or safety
  • Quality requirements
  • Other
Area
TBT: Technical product rulesTechnical barriers to trade
Notification type
Regular notification
Document symbol
G/TBT/N/JPN/915
Keywords
Human health

Key dates

Distributed by the WTO
Comment deadline
Closed on 9 October 2026
Proposed adoption
November 2026
Proposed entry into force
November 2026

How to comment

The comment period closed on 9 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/JPN/915; it can take them up with Japan.

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

What the notification says

The Minimum Requirements for Biological Products will be amended as follows: ・Regarding the standard for 'Recombinant Adsorbed Hepatitis B Vaccine (Prepared from Yeast)', 'Tests on vector and inserted gene' will be amended to 'Tests on inserted gene'. ・Regarding the standard for 'Freeze-dried Live Attenuated Rubella Vaccine', a test by Reverse Transcription Polymerase Chain Reaction (RT-PCR) may be used for the Identification Test. ・Regarding the standard for 'Freeze-dried Live Attenuated Measles Vaccine', a test by RT-PCR may be used for the Test for freedom from extraneous viruses and the Identification Test. ・In addition, regarding the standard for 'Freeze-dried Live Attenuated Measles-Rubella Combined Vaccine', a test by RT-PCR may be used for the Confirmation of the labeling.

Sources

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

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