G/TBT/N/JPN/778  
26 July 2023  
(23-5093) 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 above:   
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.; (1 page(s), in 
English)  
6. Description of content:  The Minimum Requirements for Biological Products will be 
amended as follows: The standard for "Recombinant Respiratory Syncytial virus Vaccine" 
that is to be newly approved will be added. In addition, in regard to the s tandard for 
"pH4-Treated Normal Human Immunoglobulin (Subcutaneous injection)", the section of 
"Test for immunoglobulin G content" and "Test for freedom from aggregated 
immunoglobulin G" will be partially amended and the section of "Test for pH, Storage an d 
expiry date" will be deleted.  
The Public Notice on National Release Testing will be amended as follows: The criterion, 
fee and quantity for "Recombinant Respiratory Syncytial virus Vaccine" that is to be newly 
approved will be added. In addition, the cri terion and quantity for "pH4 -Treated Normal 
Human Immunoglobulin (Subcutaneous injection)" will be partially amended.  
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 speci al 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, Efficacy and Safety of Products In cluding 
Pharmaceuticals and Medical Devices.  G/TBT/N/JPN/778  
 
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  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:  September 2023  
Proposed date of entry into force:  September 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: (+81 3) 5501 8343  
E-mail: enquiry@mofa.go.jp  
https://members.wto.org/crnattachments/2023/TBT/JPN/23_11297_00_e.pdf