1 (Attachment)  
 
Partial amendment to the Minimum Requirements for Biological 
Products  and the Public Notice on National Release Testing . 
 
1. The Minimum Requirements for Biological Products  
The Article 42, paragraph 1 of Act on Securing Quality, Efficacy and Safety of Products Including 
Pharmaceuticals and Medical Devices  (Act No. 145, 1955) stipulates that the Minister of Health, 
Labour and Welfare will establish necessary standards for the manufacturing methods, properties, 
quality, storage, etc. of drugs after seeking the opinion s of Pharmaceutical Affairs and Food Safety 
Council.  Based on this, the standards for manufacturing methods, properties, quality, and storage of 
biological product s such as vaccine and blood products are specified in the Minimum Requirements 
for Biological Products (Ministerial Notification No. 155 of the Ministry of Health, Labour and 
Welfare on 2004).  
 
2. The Public Notice on National Release Testing  
According to Act on Securing Quality, Efficacy and Safety of Products Including 
Pharmaceuticals and Medical Devices, the pharmaceuticals subject to National Release Testing 
which are designated by Minister of Health, Labour and Welfare (the Public Notice N o. 279 of 
MHW, 1963) has been notified in order to stipulate the pharmaceuticals subject to National 
Release Testing, fees, criteria and quantities for the testing.  
 
3. The summary of this amendment  
The Minimum Requirements f or Biological Products shall be  partially amended as follows ; 
 ･ GENERAL RULES  
  -   A vaccine product to be newly approved : “Recombinant Coronavirus (SARS -CoV-2) 
V accine ” 
 
The Public Notice on National Release Testing shall be partially amended as follows ; 
-   The fee, criterion and qu antity for National Release Testing of the following  vaccine will 
be amended : “Freeze -dried Gas Gangrene Antitoxin, Equine”, “Recombinant Coronavirus 
(SARS -CoV-2) V accine”, “Freeze -dried Diphtheria Antitoxin, Equine”, “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 F ibrinogen”, “Lyophilized Human Prothrombin Complex Concentrate”, 
“Freeze -dried Concentrated Blood Coagulation Factor VIII”, “Freeze -dried activated human  2 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 Immun oglobulin”, “pH4-Treated Normal Human Immunoglobulin
（Subcutaneous injection ）”, “Freeze -dried pH 4 -treated Normal Human Immunoglobulin ”, 
“Freeze -dried Pepsin -treated Normal Human Immunoglobulin ”, “Polyethylene Glycol -
treated Normal Human Immunoglobulin ”, “Freeze -dried Polyethylene Glycol -treated 
Normal Human Immunoglobulin “, “Human Anti -HBs Immunoglobulin”, “F reeze -dried 
Human Anti -HBs Immunoglobulin”, “Polyethylene 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 Glycol -treated Human Ant i-tetanus 
Immunoglobulin”, “Freeze -dried Human Antithrombin III Concentrate”, “Freeze -dried  
Human Activated Protein C Concentrate ”, and “Human Haptoglobin ”.