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Minimum Requirements for Biological Products MINIMUM REQUIREMENTS FOR BIOLOGICAL PRODUCTS National Institute of Infectious Diseases Japan, 2006 - 1 - MINIMUM REQUIREMENTS FOR BIOLOGICAL PRODUCTS Notice: This English version of the Minimum Requirements for Biological Products is prepared for the convenience of users unfamiliar with the Japanese language. When and if any discrepancy arises between the Japanese original and its English translation, the former is authentic. National Institute of Infectious Diseases Japan, 2006 - 2 - Foreword The “Minimum Requirements for Biological Products” was developed to specify the manufacturing methods, descriptive definitions, quality, storage, test methods, etc. of vaccines, antitoxins, blood products and other biological products for human use according to Article 42(1) of the Pharmaceutical Affairs Law, which states, “the Minister of Health, Labour and Welfare is authorized to establish the necessary standards for the manufacturing methods, descriptive definitions, quality, storage, etc. of drugs that require special cautions for use from the points of health and hygiene after hearing the opinions of the Pharmaceutical Affairs and Food Sanitation Council.” The Minimum Requirements for Biological Products had not been revised since 1993; however, an update had been urged because of recent scientific and technological advancement, development of new test methods, and increasing public concern about the safety of products prepared from animal or other biological materials. The update was also considered necessary to maintain consistency between the Minimum Requirements for Biological Products and such other official requirements as the Pharmaceutical Affairs Law, the Standards for Biological Materials (Ministry Ordinance No. 210 issued in 2003), the Japanese Pharmacopoeia, and World Health Organization (WHO) requirements. Thus, the Ministry of Health, Labour and Welfare established the “Expert Committee for Revision of the Minimum Requirements for Biological Products” to gather advice, recommendations, and ideas regarding revision, and prepared this updated guideline (Ministry Ordinance No. 155) in March 2004, with the intent of providing a standards guideline to meet the latest level of science and technology and the current needs of society. In 1947, the National Institute of Health (currently the National Institute of Infectious Diseases) was established as a national agency to manage and control the quality of biological preparations. The quality control system for vaccines and other biological materials was initially introduced under the guidance of the General Headquarters of the Supreme Commander for the Allied Powers. Since its establishment, the institute has continued to provide safer and more effective vaccines, strengthening collaborations with the National Control Laboratories (NCLs) of other countries and the WHO. In just the past 20 years, the institute has contributed to the manufacture and quality control of vaccines in Asian countries and other regions by accepting trainees and sending experts as part of the Official Development Assistance (ODA) program. It is my sincere hope that this publication will benefit those activities. March 1, 2006 Takeshi Kurata, M.D., Ph.D. Director-General National Institute of Infectious Diseases - 3 - CONTENTS GENERAL RULES ....................................................................................................................................7 Influenza Vaccine ...................................................................................................................................13 Influenza HA Vaccine.............................................................................................................................17 Freeze-dried Inactivated Tissue Culture Hepatitis A Vaccine.................................................................22 Freeze-dried Live Attenuated Mumps Vaccine.......................................................................................25 Gas Gangrene Antitoxin, Equine............................................................................................................30 Freeze-dried Gas Gangrene Antitoxin, Equine.......................................................................................33 Inactivated Rabies Vaccine.....................................................................................................................35 Freeze-dried Inactivated Tissue Culture Rabies Vaccine........................................................................40 Cholera Vaccine......................................................................................................................................44 Freeze-dried Diphtheria Antitoxin, Equine ............................................................................................47 Diphtheria Toxoid...................................................................................................................................50 Adsorbed Diphtheria Toxoid ..................................................................................................................54 Adsorbed Diphtheria Toxoid for Adult Use ...........................................................................................56 Diphtheria-tetanus Combined Toxoid ....................................................................................................57 Adsorbed Diphtheria-tetanus Combined Toxoid....................................................................................59 Varicella Antigen....................................................................................................................................61 Freeze-dried Live Attenuated Varicella Vaccine.....................................................................................66 Typhoid-paratyphoid Vaccine.................................................................................................................72 Purified Tuberculin.................................................................................................................................75 Smallpox Vaccine...................................................................................................................................80 Freeze-dried Smallpox Vaccine..............................................................................................................84 Smallpox Vaccine Prepared in Cell Culture ...........................................................................................86 Freeze-dried Smallpox Vaccine Prepared in Cell Culture ......................................................................90 Japanese Encephalitis Vaccine ...............................................................................................................92 Freeze-dried Japanese Encephalitis Vaccine ..........................................................................................96 Pneumococcal Vaccine Polyvalent.........................................................................................................98 Tetanus Toxoid .....................................................................................................................................107 Adsorbed Tetanus Toxoid.....................................................................................................................110 Freeze-dried Habu Antivenom, Equine ................................................................................................112 Adsorbed Habu-venom Toxoid ............................................................................................................116 Adsorbed Hepatitis B Vaccine..............................................................................................................119 Adsorbed Hepatitis B Vaccine (Prepared from huGK-14 Cells) ..........................................................124 Recombinant Adsorbed Hepatitis B Vaccine (Prepared from Yeast)....................................................127 Recombinant Adsorbed Hepatitis B Vaccine (Prepared from Chinese Hamster Ovary Cells) .............130 Recombinant Adsorbed Hepatitis B Vaccine Containing pre-S2 Antigen and HBs Antigen (Prepared from Yeast) ...........................................................................................................................................133 Freeze-dried BCG for Intravesical Use (Connaught Strain).................................................................136 Freeze-dried BCG for Intravesical Use (Japanese Strain)....................................................................140 Freeze-dried BCG Vaccine (for Percutaneous Use) .............................................................................143 Pertussis Vaccine..................................................................................................................................146 Adsorbed Purified Pertussis Vaccine....................................................................................................150 - 4 - Diphtheria-pertussis Combined Vaccine ..............................................................................................154 Diphtheria-pertussis-tetanus Combined Vaccine..................................................................................157 Adsorbed Diphtheria-purified Pertussis-tetanus Combined Vaccine....................................................160 Freeze-dried Live Attenuated Rubella Vaccine ....................................................................................165
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