Attachment 
 1Partial amendment to the Minimum Requirements for Biological 
Products. 
 
1 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 opinions of 
Pharmaceutical Affairs and Food Safety Council. Based on this, the standards for 
manufacturing methods, properties, quality, and storage of biological products 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 Minimum Requirements for Biological Products shall be mainly amended as follows； 
･ GENERAL RULES 
-  To adjust the descriptions in The Minimum Requirements for Biological Products in light 
of the current scientific level or to be consistent with the Japanese Pharmacopoeia. 
 ･ MONOGRAPHS 
  -  To update The Minimum Requirements for Biological Products to keep up with the 
revision of general rules and to current scientific level. 
  -  To update The Minimum Requirements for Biological Products with test changes of the 
monographs. 
[Influenza HA vaccine] [Freeze-dried Inactivated Tissue Culture Japanese Encephalitis 
vaccine] [Pneumococcal vaccine Polyvalent] [Freeze-dried Haemophilus influenzae type b 
vaccine (tetanus toxoid conjugate)]  
    -  To add a rule that test for freedom from abnormal toxicity can be omitted when the 
test for freedom from abnormal toxicity is continuously applied 50 times. 
[Influenza HA vaccine] 
    -  In the potency test, inactivation test, and label check test, the description should not 
be limited to chicken erythrocytes. 
[Adsorbed influenza vaccine (H5N1 strain)] 
    -  To add the potency test for subdivided final products 
[Emulsion cell culture derived influenza HA vaccine (H5N1 strain)] 
    -  In the inactivation test, the description should not be limited to chicken erythrocytes. 
[Freeze-dried Live Attenuated Mumps vaccine]，[Freeze-dried Live Attenuated Rubella 
vaccine], [Freeze-dried Live Attenuated Measles vaccine], [Freeze-dried Live Attenuated 
Measles, Rubella Combined vaccine] Attachment 
 2        -  To change to perform neurovirulence test or attenuated test for seed lot. 
[Freeze-dried Diphtheria Antitoxin, Equine]，[Freeze-dried Habu Antivenom, Equine], 
[Freeze-dried Mamushi Antivenom, Equine], [Freeze-dried Botulism Antitoxin, Equine], 
[Freeze-dried Gas Gangrene Antitoxin, Equine] 
    -  To delete sterility test and pyrogen test in antitoxin solution manufacturing method. 
[Freeze-dried Live Attenuated Varicella vaccine] 
 -  To delete "trypsin and bovine serum" in Source materials. 
 [Smallpox vaccine Prepared in Cell Culture]  
    -  To change the stage of dilution in the pock forming unit measurement method and 
the plaque forming unit measurement method. 
[Freeze-dried BCG for Intravesical Use (Japan strain)] [Freeze-dried BCG vaccine] 
    -  To delete description about passage in manufacturing method. 
    -  To change description of culture period and specific bacteria in manufacturing 
method. 
   [Adsorbed Purified Pertussis vaccine] [Adsorbed purified pertussis diphtheria tetanus 
mixed vaccine] 
    -  To change in the measurement of viable cell count using a blood-enriched medium in 
the potency test. 
   [Adsorbed purified pertussis diphtheria tetanus inactivated polio (Sabin strain) Combined 
vaccine] 
    -  To add a cell line that will be used to test the purified virus suspension. 
   [Whole Human Blood] [Fresh-frozen Human Plasma] [Platelet Concentrate] 
    -  To change the sample extraction proportion in the sterility test. 
[Frozen-thawed Human Red Blood Cells] 
-  To change the total hemoglobin amount to be measured in test for hemoglobin content. 
[Freeze-dried Sulfonated Normal Human Immunoglobulin] 
-  To change the operation in the test for sulfonation. 
   [Freeze-dried Human Antithrombin III Concentrate]  
    -  To change the dilution level of the sample and standard in the potency test. 
[Gas Gangrene Antitoxin, Equine][Cholera vaccine][Diphtheria-tetanus Combined 
Toxoid][Japanese Encephalitis vaccine][Freeze-dried Japanese Encephalitis 
vaccine][Precipitated 7-valent Streptococcus pneumoniae-binding vaccine (non-toxic 
mutant diphtheria toxin binding Body)][Pertussis vaccine][Diphtheria-pertussis Combined 
vaccine][Diphtheria-pertussis-tetanus Combined vaccine][Adsorbed Haemophilus 
influenzae type b vaccine (Non-toxic Mutant Diphtheria Toxin Complex)][Live Oral 
Poliomyelitis vaccine][Freeze-dried Live Attenuated Measles, Mumps, Rubella Combined 
vaccine][Weil's Disease and Akiyami Combined vaccine][Freeze-dried Human Blood Attachment 
 3Coagulation Factor VIII][Reduced Alkylated Normal Human Immunoglobulin][Freeze-
dried Plasmin-treated Normal Human Immunoglobulin][Freeze-dried Polyethylene 
Glycol-treated Human Anti-HBs Immunoglobulin][Freeze-dried Polyethylene Glycol-
treated Human Anti-tetanus Immunoglobulin] 
    -  To delete the item because there is no supply schedule. 
 ･ GENERAL TESTS 
-  To update descriptions to follow current scientific level. 
 ･  OTHERS 
  -  To update necessary descriptions. 
-  This amendment will be promulgated on April 2020.