G/TBT/N/JPN/767  
6 April 2023  
(23-2523) 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.; (2 page(s), in  
English)  
6. Description of content:  The Minimum Requirements for Biological Products will be 
partially amended. A vaccine product to be newly approved: "Recombinant Coronavirus 
(SARS -CoV-2) Vaccine"  
The Public Notice on National Release Testing will be partially amended. The fee, criterion 
and quantity for National Release Testing of the following vaccine will be amended: 
"Freeze -dried Gas Gangrene Antitoxin, Equine", "Recombinant Coronavirus (SARS -CoV-
2) Vaccine", "Freeze -dried Diphtheria Antitoxin, Equ ine", "Freeze -dried Habu Antivenom, 
Equine", "Freeze -dried Botulism Antitoxin, Equine", "Freeze -dried Mamushi Antivenom, 
Equine", "Human Plasma Protein Fraction", "Human Serum Albumin", "Freeze -dried 
Human Fibrinogen", "Lyophilized Human Prothrombin Comple x Concentrate", "Freeze -
dried Concentrated Blood Coagulation Factor VIII", "Freeze -dried activated human blood 
coagulation factor VII concentrate containing factor X", "Normal Human 
Immunoglobulin", "Freeze -dried Ion -exchange -resin-treated Normal Human 
Immunoglobulin", "Freeze -dried Sulfonated Normal Human Immunoglobulin", "pH 4 -
treated Normal Human Immunoglobulin", "pH4 -Treated Normal Human Immunoglobulin 
（ Subcutaneous injection ）", "Freeze -dried pH 4 -treated Normal Human 
Immunoglobulin", "Freeze -dried Pep sin-treated Normal Human Immunoglobulin", 
"Polyethylene Glycol -treated Normal Human Immunoglobulin", "Freeze -dried 
Polyethylene Glycol -treated Normal Human Immunoglobulin ", "Human Anti -HBs 
Immunoglobulin", "Freeze -dried Human Anti -HBs Immunoglobulin", "Po lyethylene Glycol -
treated Human Anti -HBs Immunoglobulin", "Human Anti -D(Rho) Immunoglobulin", 
"Freeze -dried Human Anti -D(Rho) Immunoglobulin", "Human Anti -tetanus 
Immunoglobulin", "Freeze -dried Human Anti -tetanus Immunoglobulin", "Polyethylene G/TBT/N/JPN/767  
 
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  Glycol -treated Human Anti -tetanus Immunoglobulin", "Freeze -dried Human Antithrombin 
III Concentrate", "Freeze -dried Human Activated Protein C Concentrate", and "Human 
Haptoglobin".  
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 st ipulate 
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, Efficacy and Safety of Products Including Pharmaceuticals and 
Medical Devices.  
https://www.japaneselawtranslation.go.jp/en/laws/view/3213  
This amendment wil l be published in " KAMPO " (Official Gazette) when adopted.  
9. Proposed date of adoption:  June 2023  
Proposed date of entry into force:  June 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_8789_00_e.pdf