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動物医薬品検査所

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Examination for the approval of new VMPs

Any person wishing to manufacture (import) VMPs shall obtain a manufacturing (import) approval and manufacturer's (importer's) license from the Minister of Agriculture, Forestry and Fisheries.
The NVAL reviews technical examination and reliability standards conformity about the data attached to manufacturing (import) approval applications.
The NVAL collects and provides information on approved VMPs to allow the periodic verification of their efficacy and safety.

Review of new drug applications regarding "compliance with the application data reliability standards“ as well as technical examination of the data

On Good Laboratory Practice(GLP) Good Clinical Practice(GCP) and Good Post-Marketing Study Practice(GPSP),NVAL has inspected facilities to determine whether they conform to these standards.

Collection and screening of information necessary for reevaluation of VMPs

Reevaluation shall be performed to verify the efficiency and safety of VMPs regularly, based on the most recent studies, and to ensure quality. NVAL has been collecting and compiling a large number of data as well as information about the efficiency and safety of all approved VMPs. These date and information, after selection, arrangement and processing, are used for discussion about reevaluation of the VMPs by the Pharmaceutical Affairs and Food Sanitation Council.

Collection and provision of information about VMPs, and consultation on VMPs

With the enactment of the Product Liability Act, NVAL is in charge of prevention of accidents and injuries caused by VMPs as follows:

(1) construction of database on products and test data on approved drugs, information on adverse drug reactions, complaints, accidents, antigen analysis of field strains

(2) supply of information

(3) consultation on accidents, injuries, and complaints

(4) component analysis or other tests on VMPs causing accidents and injuries

(5) antigen analysis of fileld strains

Investigation to establish the standards on the use of VMPs

To approve veterinary drugs simply and quickly, and to enhance the efficiency and safety of veterinary drugs, NVAL performs inspections and carries out research to determine or revise the standards.

(1) To determine new standards for drugs that may not require approval, NVAL compares existing standards and testing methods, or investigates new appropriate testing methods.

(2) For food safety standards, regulations on chemical VMPs were enacted. NVAL evaluates the methods applied for residue analysis of drugs and defines the limits of drug utilization.