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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 Partial amendment to the Public Notice on National Release Testing

Japan notified this proposed TBT measure to the WTO on 31 July 2026. The comment period closed on 30 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

Pharmaceutical products (HS: 30)

HS codes
  • 30 · Pharmaceutical products
    • 30
Notifying member
Japan
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/JPN/913

Key dates

Distributed by the WTO
Comment deadline
Closed on 30 August 2026
Proposed adoption
September 2026
Proposed entry into force
September 2026

How to comment

The comment period closed on 30 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/JPN/913; 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: The standard for 'Recombinant Herpes Zoster Vaccine (Prepared from Chinese Hamster Ovary Cells)' that is to be newly approved will be added. And regarding the standard for 'Recombinant Coronavirus (SARS-CoV-2) Vaccine', the article of 'Virus seed lot' and 'Virus-infected cell suspension' in the section of 'Production control' will be partially amended. In addition, regarding the standard for 'Inactivated Polio Vaccine', the article of 'Potency test' in the section of 'Tests on final product' will be partially amended. The Public Notice on National Release Testing will be amended as follows: The criterion, fee, quantity and Institution for National Release Testing for 'Recombinant Herpes Zoster Vaccine (Prepared from Chinese Hamster Ovary Cells)' that is to be newly approved will be added. And the criterion, fee, and quantity for 'Freeze-dried Recombinant Herpes Zoster Vaccine (Prepared from Chinese Hamster Ovary Cells)' and 'Freeze-dried Smallpox Vaccine Prepared in Cell Culture' will be partially amended. In addition, the fee and quantity for 'Adsorbed Diphtheria-purified Pertussis-tetanus-inactivated polio Combined Vaccine' and 'Adsorbed Diphtheria-purified Pertussis-tetanus-inactivated polio Haemophilus TYPE b Combined Vaccine' will be partially amended.

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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