G/TBT/N/JPN/791  
5 January 2024  
(24-0109) 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 Require ments 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:  
･ GENERAL RULES  
The standard  for "Tissue Culture Tick -borne Encephalitis Virus Vaccine", "Pneumococcal 
20-valent Conjugate Vaccine" and "Freeze -dried Human Protein C Concentrate" those are 
to be newly approved will be added.  
・GENERAL TESTS  
Regarding the standard for "Antibody Assay against Measles Virus", "Enzyme -linked 
Immunosorbent Assay" will be added.  
The Public Notice on National Release Testing will be amended as follows:  
The criterion, fee, and quantity for "Tissue Culture Tick -borne Encephalitis Virus Vaccine" , 
"Pneumococcal 20 -valent Conjugate Vaccine" and "Freeze -dried Human Protein C 
Concentrate" that are to be newly approved will be added. And the criterion, fee, and 
quantity for "Freeze -dried Inactivated Tissue Culture Rabes Vaccine", "Freeze -dried 
Human F ibrinogen", "Freeze -dried Polyethylene Glycol -treated Normal Human 
Immunoglobulin" and "Freeze -dried Human Antithrombin Ⅲ Concentrate" will be partially 
amended. In addition, the criterion and fee for "Human Haptoglobin" will be partially 
amended.  G/TBT/N/JPN/791  
 
- 2 - 
 
  7. Obje ctive 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 pu blic 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, an d 
quantity 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.  
9. Proposed date of adoption:  March 2024  
Proposed date of entry into force:  March 2024  
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/2024/TBT/JPN/24_00093_00_e.pdf