JPN/761
WTO/TBT
JP Japan
  • 30 - Pharmazeutische Erzeugnisse
2023-02-22
2023-01-24

Pharmaceutical products (HS: 30)

Partial amendment to the Minimum Requirements for Biological Products. Partial amendment to The Public Notice on National Release Testing.; (2 page(s), in English)

The Minimum Requirements for Biological Products will 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", "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") will 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 will 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".