 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 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 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 No. 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 for Biological Products shall be amended as follows； 
 ･ GENERAL RULES 
  -   To add the standard for a vaccine product to be newly approved; “Nasally Live Attenuated 
Influenza Vaccine”, “Adsorbed Diphtheria-purified Pertussis-tetanus-inactivated polio 
Haemophilus TYPE b Combined Vaccine”. Partially amended to “Diphtheria Toxoid”, 
“Adsorbed Diphtheria Toxioid”, “Adsorbed Diphtheria Toxioid for Adult Use”, “Adsorbed 
Diphtheria-tetanus Combined Toxoid”, “Tetanus Toxoid”, “Adsorbed Tetanus Toxoid”, 
“Adsorbed Purified Pertussis Vaccine”, “Adsorbed Diphtheria-purified Pertussis-tetanus 
Combined Vaccine”, “Adsorbed Diphtheria-purified Pertussis-tetanus-inactivated polio (Sabin 
strain) Combined Vaccine”, “Freeze-dried Haemophilus TYPE b Vaccine (Tetanus Toxoid 
Conjugate)”, “Inactivated Polio Vaccine (Salk Vaccine)”. To delete “Adsorbed Diphtheria-
purified Pertussis-tetanus-inactivated polio (Salk Vaccine) Combined Vaccine”. 
  -   The test for pH and test for abnormal toxicity (“test for freedom from abnormal toxicity”)  2will be deleted from monographs for “Freeze-dried Inactivated Tissue Culture Hepatitis A 
Vaccine”, “Freeze-dried Gas Gangrene Antitoxin, Equine”, “Freeze-dried Inactivated Tissue 
Culture Rabies Vaccine”, “Freeze-dried Diphtheria Antitoxin, Equine”, “Freeze-dried Habu 
Antivenom, Equine”, “Freeze-dried Botulism Antitoxin, Equine”, “Freeze-dried Mamushi 
Antivenom, Equine”. 
 
The Public Notice on National Release Testing shall be amended as follows； 
 - To add the standard for a vaccine product to be newly approved; “Nasally Live Attenuated 
Influenza Vaccine”, “Adsorbed Diphtheria-purified Pertussis-tetanus-inactivated polio 
Haemophilus TYPE b Combined Vaccine”. Partially amended to “Diphtheria Toxoid”, 
“Adsorbed Diphtheria Toxioid”, “Adsorbed Diphtheria Toxioid for Adult Use”, “Adsorbed 
Diphtheria-tetanus Combined Toxoid”, “Zoster Vaccine Recombinant, Adjuvanted”, “Tetanus 
Toxoid”, “Adsorbed Tetanus Toxoid”, “Adsorbed Purified Pertussis Vaccine”, “Adsorbed 
Diphtheria-purified Pertussis-tetanus Combined Vaccine”, “Adsorbed Diphtheria-purified 
Pertussis-tetanus-inactivated polio (Sabin strain) Combined Vaccine”, “Freeze-dried 
Haemophilus TYPE b Vaccine (Tetanus Toxoid Conjugate)”, “Inactivated Polio Vaccine (Salk 
Vaccine)” “Freeze-dried Inactivated Tissue Culture Hepatitis A Vaccine”, “Freeze-dried Gas 
Gangrene Antitoxin, Equine”, “Freeze-dried Inactivated Tissue Culture Rabies Vaccine”, 
“Freeze-dried Diphtheria Antitoxin, Equine”, “Freeze-dried Habu Antivenom, Equine”, 
“Freeze-dried Botulism Antitoxin, Equine”, “Freeze-dried Mamushi Antivenom, Equine”, 
“Human Anti-tetanus Immunoglobulin”. Accordingly, the fee, criterion and quantity for 
National Release Testing of the above-mentioned vaccine will be partially amended. To delete 
“Adsorbed Diphtheria-purified Pertussis-tetanus-inactivated polio (Salk Vaccine) Combined 
Vaccine”. 