Examination for the approval of new veterinary drugs
Any person wishing to manufacture(import)drugs 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 animal drugs 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
●Collection and screening of information necessary for reevaluation of veterinary drugs
●Collection and provision of information about veterinary drugs,and consultation on veterinary drugs
●Investigation to establish the standards on the use of veterinary drugs
●Measures to monitor and control drug resistant bacteria(e.g.drug susceptibility test of bacteria recovered from animals)
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.
Reevaluation shall be performed to verify the efficiency and safety of animal drugs 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 various veterinary drugs. This information, after selection, arrangement and processing, is used by the Pharnaceutical Affairs and Food Sanitation Council.
With the enactment of the Product Liability Act, NVAL is in charge of prevention of accidents and injuries caused of veterinary drugs 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 animal drugs causing accidents and injuries
(5) antigen analysis of fileld strains
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 antiblotic product use were enacted. NVAL evaluates the methods applied for residue analysis of drugs and defines the limits of drug utilization.