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Comprising representatives from the Pharmaceutical Society, The Veterinary Services Council, Federated Farmers, Pharmaceutical Manufacturers, AGCARM, Wallaceville Animal Research Centre, Health and Agriculture Departments.
Under the Animal Remedies Act 1967 manufacturers either in New Zealand or overseas, and importers, must apply for a licence prior to marketing their animal remedies. This Act applies to any drug, medicine, remedy or therapeutic preparation or any biochemical substance manufactured, imported or advertised. Appendix VII of the Animal Remedies Licensing Procedures outline the demand for the LD50 "test" as under:
- LD50 data on two unrelated species, one of which should be a non-rodent and by three methods of administration. ie oral, skin and inhalation.
- Separate tests on male and female in one test species and rat data to be given plus those for dogs, cats or monkeys. Trials to be designed along lines generally accepted by toxicologists and results to be certified by the laboratory and scientists conducting the trials."
- "Animal tests to consist of daily oral administration of the test compound for two years on two species, often the rat and the dog."
- "There should be a control group and at least three dosage levels of which one should be toxic and one non-toxic. To ensure adequate number of survivals the rat group should have at least 20 females and 20 males at the start."
- "Separate toxicological data should be submitted for each active ingredient if there is more than one ingredient to the product."
- "Even though the substance has become well-known overseas an extensive background in development work is looked for and New Zealand trials should be included."
"Evidence from overseas is acceptable, but if a product is developed under conditions not usually found in New Zealand then the Board requires evidence from New Zealand trials to show that it will perform as claimed. Laboratory and target animal treatments should be reported. Applicants should set out conclusions drawn from all the data available."
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3. The Drug Assessment Advisory Committee
4. The Restricted Drugs Committee
Both the above agencies are comprised of nominees from the Pharmaceutical Society, the Medical Association and the Department of Health. The former "advises on the safety and efficiency of new drugs and on matters concerning the availability of new existing drugs in New Zealand". The latter "makes recommendations to the Minister of Health on the classification of medicines".
Regulations are stipulated in the Health Department's drug distribution guide "A Guide for Importers, Manufacturers, Distributors, and Those Marketing Drugs in New Zealand"... much of which outlines demands for the LD50 "test". Brief extracts as shown below:
- Acute toxicity "Data are to be provided from at least three mammalian species, one of which should be a non-rodent other than the rabbit. The drug is to be given by the proposed clinical route in all species and by the oral route and by injection in at least one of them."
- Prolonged toxicity "Data are to be provided from at least two mammalian species of both sexes, one a non-rodent other than the rabbit. Several dose levels should be employed."
- Reproduction studies "Data are to be provided about any embryotoxic and teratogenic effects in at least two mammalian species and about any adverse peri and post natal effects in at least one mammalian species."
- Data are to be provided about any adverse effects on the fertility general reproduction ability of males and females, and the female reproduction cycle in at least one mammalian species."
"The information should be detailed enough to enable the work to be repeated by an independent investigator and to allow scientific assessment."
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