1 (Attachment)  
 
Partial amendment to the Minimum Requi rements for Biological Products  
 
 
1 The Paragraph 1, Article 42 of the Pharmaceutical Affairs Law (Act No. 145, 19 60) stipulates 
that the Minister of Health, Labour and Welfare will establish necessary standards for the 
manufacturing methods, properties, quality, storage, etc. of drugs that require special precaution 
to public health after hearing the opinion of Pharmac eutical Affairs and Food Safety Council.  
In accordance with this provision , the standards for manufacturing methods, properties, quality, 
and storage of biological products , such as vaccine s and blood products , are specified in the 
Minimum Requirements fo r Biological Products (Ministerial Notification No. 155 of the 
Ministry of Health,  Labour and Welfare , 2004).  
 
2 Outline of the amendments of The Minimum Requirements for Biological Products is as 
follows : 
GENERAL RULES  
- Addition of  the description of the Seed -Lot-System in No.17 on general rules  
- Deletion of  the No.40 from general rules  
- Deletion  of the description of  labelling in No.42 on general rules  
  
MONOGRAPH S 
- Maintenance of Monographs  in line  with the amendment  of General Rules above  
- Updat e of Monograph s with necessary amendment including deleting test methods of the 
following monographs : 
[Influenza HA Vaccine ] 
- Maintenance of the  monograph with deleting Fraction Tests on final product s  
[Freeze -dried Live Attenuated Mumps Vaccine ] 
- Update of the  monograph to reflect the Seed -Lot-System  
- Modification of  the description o f expiry date  
[Diphtheria  toxoid ],[Adsorbed  diphtheria  toxoid ], [Adsorbed  diphtheria toxoid for adult 
use], [Diphtheria -tetanus combined toxoid ], [Adsorbed dip htheria -tetanu s combined toxoid ] 
- Update of  the monograph with deleting guinea pig tests on final product s 
[Varicella Antigen]  
- Modification of  the description o f expiry date   2 [Freeze -dried Live Attenuated V aricella Vaccine ] 
- Modification of  the description o f expiry date  
[Smallpox Vaccine Prepared in Cell Culture ] 
- Replacement of the  Marker  Tests on final bulk  to the Tests on bulk material  
[Freeze -dried Japanese Encephalitis Vaccine  Prepared in Cell Culture ]  
- Amendment of the  Potency Tests to those without using animal s 
[Adsorbed Habu -venom Toxoid ] 
- Deletion of the  monograph from the MONOGRAPHS  
[Recombinant Adsorbed Hepatitis B V accine (Prepared from Yeast)  ] 
- Addition of  the description o f the number of  tests as the A bnormal Toxicity Test 
[Freeze -dried BCG for Intravesical  Use (Connaught Strain)  ] 
- Amendments of the description in the clause of “Cultivation and Harvesting” and “Test 
for freedom from virulent mycobacteria ”  
- Addition of  “normal saline solution”  to the category  of “lysis solution ” 
[Adsorbed Purified Pertuss is Vaccine ]  
- Deletion of the  “Test for mouse body weight -decreasing toxicity ” 
[Adsorbed Diphtheria -Purified Per tussis -Tetanus Combined Vaccine ] 
- Deletion of the  “Test for mouse body weight -decreasing toxicity ” 
- Modification of  the description o f expiry date 
[Freeze -dried Live Attenuated Rubella Vaccine ] 
- Update of the monograph to reflect the Seed -Lot-System  
- Modification of  the description o f expiry date  
[Freeze -dried Live Attenuated Measles V accine ] 
- Update this monograph to reflect the Seed-Lot-System  
[Freeze -dried Live Attenuated Me asles, Rubella Combined V accine ] 
- Modification of  the description of expiry date  
[Whole Human Blood ] 
- Deletion of  the description o n plasma components separation  
- Addition of the  “modified  thioglycollate med ium” 
- Maintenance of  the description o f labeling on blood sample (segment tube) for 
laboratory test  
[Concentrated Human Red Blood Cells ] 
- Deletion of  “Concentrated ” from the name of the monograph to “Human Red Blood 
Cells ” 
- Maintenance of  the description of labeling on blood sample (segment tube) for  3 laboratory test  
[Washed Human Red Blood Cells ] 
- Modification of  the Japanese name  of the monograph  to “Washed Human Red Blood 
Cells ” (no change in unofficial English translation)  
- Maintenanc e of the description of labeling on blood sample (segment tube) for 
laboratory test  
[Leukocyte -poor Red Blood Cells ] 
- Deletion of  the monograph from the MONOGRAPHS  
[Concentrated Froz en-thawed Human Red Blood Cells ] 
- Deletion of  “Concentrated ” from the name of the monograph to “Frozen -thawed Human 
Red Blood Cells ” 
- Addition of  the description of the measurement  by automatic analyzer on the “Test for 
hemoglobin content ” 
- Maintenance of  the description of labeling on blood sample (segment tube) for 
laboratory test  
[Fresh -frozen Human Plasma ] 
- Addition of  the description of the measurement  by automatic analyzer on the 
“Coagulation Test ” 
- Modification of  the description of expiry date  on the monograph  
- Maintenance of  the description of labeling on b lood sample (segment tube) for 
laboratory test  
[Platelet Concentrate ] 
- Maintenance of  the description of “Sterility test ” in line with Article 3.3 of the 
monograph of  “Fresh -frozen Human Plasma ” 
- Maintenance of  the description of labeling on blood sample  (segment tube) for 
laboratory test  
[Human Anti -tetanus Immunoglobulin ], [Freeze -dried Human Anti -tetanus Immun oglobulin ], 
[Polyethylene Glycol -treated Hu man Anti -tetanus Immunoglobulin ], [Freeze -dried 
Polyethylene Glycol -treated Hu man Anti -tetanus Immunog lobulin ] 
- Shortening  of the observation  period of  mice in “Test for Tetanus Antitoxin Titer 
Determination ” 
[Freeze -dried Hum an Antithrombin III Concentrate ]  
- Addition of  the description of the measurement  by automatic analyzer on the “Potency 
Test” 
  4 GENERAL  TESTS  
- Maintenance of  descriptions in light of the  current situation  
[Test Procedures ]  
- Addition of  the description of the number of the tests on “Criterion for judgment ” in 
“Test for Freedom from Abnormal Toxicity ” 
- Revision of  “Mycoplasma Test ” 
- Revision of  “Neutralization Test” in “Antibody Assays against Measles Virus ” 
- Maintenance of  “Antibody Assays against Measles Virus ” 
- Maintenance of  “Sterility Test ” in line with the  revised Japanese Pharmacopoeia  
[Standards, Reference Prep arations, Test  Toxins and Units ] 
- Maintenance of  description s in light of the advancements of  analytical technolog ies and 
other s 
[Reagents, Test Solutions, etc.  ] 
- Maintenance of  descriptions in light of the  advancements of analytical technolog ies and 
others  
- Maintenan ce of the description of “Media for Mycoplasma Test ” 
  
OTHERS  
- Maintenance of  other necessary descriptions  
 
3  Date of Promulgation  
The amendment is expected to be  promulgated on  March or April 2013 .