These
items are tested for their properties and/or safety with respect
to human health
and/or the environment. The
non-clinical health and environmental
safety
studies are intended for submission to regulatory or receiving authorities
for the purpose of registering or licensing pharmaceutical,
pesticide, food or feed additive, cosmetic or veterinary drug products;
or for regulating industrial chemicals. IANZ
will grant a GLP compliance registration for these types of studies
and for the purposes indicated.
These
items are tested for their properties and/or safety with respect
to human health and/or the environment. The non-clinical health
and environmental safety studies are intended for submission to
regulatory or receiving authorities for the purpose of registering
or licensing pharmaceutical, pesticide, food or feed additive, cosmetic
or veterinary drug products; or for regulating industrial chemicals.
IANZ will grant a GLP compliance registration for these types of
studies and for the purposes indicated.
Test categories
Typically, non-clinical safety tests fall into the following categories:
-
Physical-chemical testing
- Toxicity
studies
- Mutagenicity
studies
- Environmental
toxicity studies on aquatic and terrestrial organisms
- Studies
on behaviour in water, soil and air
- Residue
studies
- Studies
on the effects on mesocosms and natural ecosystems
- Analytical
and clinical chemistry testing.
Other
types of trials on test items (such as clinical trials) related
to non-safety testing (e.g. efficacy) are outside the scope of application
of the IANZ GLP Compliance Monitoring Programme.
Regulatory
requirements
Many economies within the OECD mandate GLP compliance statements
accompanying the submission of such data. New Zealand regulatory
authorities do not currently require such studies to be conducted
in accordance with Good Laboratory Practice.
The New Zealand Food Safety Authority (NZFSA), Agricultural Compounds
and Veterinary Medicines (ACVM) Group (the New Zealand regulatory
authority for pesticide products, veterinary drugs and feed additives)
require GLP compliance for residue studies. For further information
see the NZFSA
website.
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