G/TBT/N/JPN/784  
27 October 2023  
(23-7247) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  English  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member:  JAPAN  
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:   
Ministry of Health, Labour and Welfare  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from ab ove:  
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 or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  
Pharmaceutical products (HS: 30)  
5. Title, number of pages and language(s) of the notified document:  Partial 
amendment to the Minimum Requirements for Biological Products  
Partial amendment to The Public Notice on National Release Testing.; (2  page(s), in 
English)  
6. Description of content:  The Minimum Requirements for Biological Products will be 
amended as follows: The standard for "Frozen Human Red Blood Cells" that is to be newly 
approved will be added. And regarding the standard for "Recom binant Respiratory 
Syncytial virus Vaccine", the section of "Cell Bank" and "Identification test on cultured 
CHO cell" will be partially amended. In addition, regarding the standard for "Coronavirus 
(SARS -CoV-2) RNA Vaccine", the section such as "Descripti ve definition" , "Bulk material" 
and "Identity test" will be partially amended.  
The Public Notice on National Release Testing will be amended as follows: The quantity 
for "Coronavirus (SARS -CoV-2) RNA Vaccine" will be partially amended. And, the criterion,  
fee and quantity for "Freeze -dried Gas Gangrene Antitoxin, Equine", "Freeze -dried 
Diphtheria Antitoxin, Equine", "Freeze -dried Recombinant Herpes Zoster Vaccine 
(Prepared from Chinese Hamster Ovary Cells)", "Freeze -dried Habu Antivenom, Equine", 
"Freeze -dried Botulism Antitoxin, Equine" and "Freeze -dried Mamushi Antivenom, Equine" 
will be partially amended. In addition, "Adsorbed Diphtheria -purified Pertussis -tetanus 
Combined Vaccine (bulk material)" and "Adsorbed Diphtheria -purified Pertussis -tetanus -
inactivated polio Combined Vaccine (bulk material)" will be deleted.  G/TBT/N/JPN/784  
 
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  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 and 
quantity for the testing.  
8. Relevant documents:   
Act on Securing Quality, Eff icacy 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.  
9. Proposed date of adoption:  December 2023  
Proposed date of entry into force:  December 2023  
10. Final date for comments:  30 days from notification  
11. Texts available from:  National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
Japan Enquiry Point  
International Trade Division,  
Economic Affairs Bureau,  
Ministry of Foreign Affairs  
Fax: (+8 1 3) 5501 8343  
E-mail: enquiry@mofa.go.jp  
https://members.wto.org/crnattachments/2023/TBT/JPN/23_13178_00_e.pdf