Amendment to the Minimum Requirements for Biological Products Shall Be Established As Follows;

G/TBT/N/JPN/105

Description of content:

Amendment to the Minimum Requirements for Biological Products shall be established as follows;

To amend 2 articles under the section of General Notice

(List 1)

To add 2 articles under the section of General Notice

(List 2)

To delete 2 articles under the section of General Notice

(List 3)

To amend 87 monographs under the section of Monographs

(List 4)

To delete 2 monographs under the section of Monographs

(List 5)

To amend 15 test methods etc. under the section of General Testing Methods

(List 6)

To add 1 test method under the section of General Testing Methods

(List 7)

List 1

７、１５、１６、２０、２１、２４、４４

List 2

Bioassay unit

Foreign Insoluble Matter Test for Injections

List 3

８、２２

List 4

Influenza Vaccine

Influenza HA Vaccine

Freeze-dried Inactivated Tissue culture Hepatitis A Vaccine

Freeze-dried Live Attenuated Mumps Vaccine

Gas Gangrene Antitoxin, Equine

Freeze-dried Gas Gangrene Antitoxin, Equine

Inactivated Rabies Vaccine

Freeze-dried Inactivated Tissue Culture Rabies Vaccine

Cholera Vaccine

Freed-dried Diphtheria Antitoxin, Equine

Diphtheria Toxoid

Adsorbed Diphtheria Toxoid

Adsorbed Diphtheria Toxoid for Adult Use

Diphtheria-Tetanus Combined Toxoid

Adsorbed Diphtheria-Tetanus Combined Toxoid

Varicella Skin Test Antigen

Freeze-dried Live Attenuated Varicella Vaccine

Typhoid-Paratyphoid Vaccine

Purified Protein Derivative Tuberculin

Smallpox Vaccine

Freeze-dried Smallpox Vaccine

Smallpox Vaccine Prepared in Cell Culture

Freeze-dried Smallpox Vaccine Prepared in Cell Culture

Japanese Encephalitis Vaccine

Freeze-dried Japanese Encephalitis Vaccine

PneumococcalVaccine

Tetanus Toxoid

Adsorbed Tetanus Toxoid

Freeze-dried Habu Antivenom, Equine

Adsorbed Habu-venom Toxoid

Adsorbed Hepatitis B Vaccine

Adsorbed Hepatitis B Vaccine (Derived from huGK-14 cell)

Recombinant Adsorbed Hepatitis B Vaccine(Derived from Yeast)

Recombinant Adsorbed Hepatitis B Vaccine(Derived from Chinese-Hamster Ovary Cell)

Recombinant Adsorbed Hepatitis B Vaccine containing pre-S2 and HBs (Derived from Yeast)

Freeze-dried BCG Intravesical(Connaught)

Freeze-dried BCG Intravesical(Japan)

Freeze-dried BCG Vaccine(for Percutaneous Use)

Pertussis Vaccine

Adsorbed Purified Pertussis Vaccine

Diphtheria-Pertussis Combined Vaccine

Diphtheria-Pertussis-Tetanus Combined Vaccine

Adsorbed Diphtheria-Purified Pertussis-Tetanus Combined Vaccine

Freeze-dried Live Attenuated Rubella Vaccine

Typhus Vaccine

Freeze-dried Botulism Antitoxin, Equine

Live Oral Poliomyelitis Vaccine

Freeze-dried Live Attenuated Measles Vaccine

Freeze-dried Live Attenuated Measles-Mumps-Rubella Combined Vaccine

Freeze-dried Mamushi Antivenom, Equine

Weil’s Disease and Akiyami Combined Vaccine

Whole Human Blood

Concentrated Human Red Blood Cells

Washed Human Red Blood Cells

Leucocyte Poor Red Blood Cells

Concentrated Frozen-thawed Human Red Blood Cells

Fresh-Frozen Human Plasma

Concentrated Human Platelet

Human Plasma Protein Fraction

Human Serum Albumin

Freeze-dried Human Fibrinogen

Freeze-dried Human Blood Coagulation Factor Ⅷ

Freeze-dried Concentrated Human Blood Coagulation Factor Ⅷ

Freeze-dried Human Blood Coagulation Factor Ⅸ Complex

Freeze-dried Concentrated Human Blood Coagulation Factor Ⅸ

Human Normal Immunoglobulin

Reduced Alkylated Human Normal Immunoglobulin

Freeze-dried Ion-Exchange-Resin Treated Human Normal Immunoglobulin

Freeze-dried Sulfonated Human Normal Immunoglobulin

pH4 Treated Human Normal Immunoglobulin

Freeze-dried pH4 Treated Human Normal Immunoglobulin

Freeze-dried Plasmin Treated Human Normal Immunoglobulin

Freeze-dried Pepsin Treated Human Normal Immunoglobulin

Polyethylene Glycol Treated Human Normal Immunoglobulin

Freeze-dried Polyethylene Glycol Treated Human Normal Immunoglobulin

Human Anti-HBs Immunogloblin

Freeze-dried Human Anti-HBs Immunogloblin

Polyethylene Glycol Treated Human Anti-HBs Immunoglobulin

Freeze-dried Polyethylene Glycol Treated Human Anti-HBs Immunoglobulin

Human Anti-D(Rho) Immunoglobulin

Freeze-dried Human Anti-D(Rho) Immunoglobulin

Human Anti-Tetanus Immunoglobulin

Freeze-dried Human Anti-Tetanus Immunoglobulin

Polyethylene Glycol Treated Human Anti-Tetanus Immunoglobulin

Freeze-dried Polyethylene Glycol Treated Human Anti-Tetanus Immunoglobulin

Freeze-dried Concentrated Human Antithrombin Ⅲ

Freeze-dried Concentrated Activated Human Protein C

Human Haptoglobin

List 5

Freeze-dried Tetanus Antitoxin, Equine

Resuspended Frozen-thawed Human Red Blood Cells

List 6

ATesting Methods

Test for Aluminium Content

Test for Freedom from Abnormal Toxicity

Endotoxin Test

Test for Potassium Content

Test for Anti-D Antibody Activity

Test for Protein Content

Test for Thimerosal Content

Test for Sugar Content

Test for Sodium Content

Stability Test for Heating

Test for Tetanus Antitoxin Activity

Pyrogen Test

Test for Formaldehyde Content

Test for Freedom from Mycoplasma

Sterility Test

BStandards, Reference Preparations, Test Toxins and Units

CReagents, Test solutions, etc

D Culture Media

List 7

Weight Variation Test