Glossary

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Clinical Trials New medicine icon

There are three main types of clinical trials:

Phase I trials are initial studies to determine the metabolism and pharmacological actions of a drug in humans, the adverse reactions associated with increasing doses, and, if possible, to gain early evidence of effectiveness. Healthy participants and/or patients may be involved in phase I trials. The ultimate goal of Phase I trials is to obtain sufficient information for the design of Phase II trials.

Phase II trials are controlled clinical studies conducted to evaluate the effectiveness of the drug for patients with the disease or condition under study and to determine the common short-term side effects and risks.

Phase III trials are started if a potential medicine shows promise in phase I and II trials. Phase III trials usually involve many more patients and are intended to gather additional information to evaluate the overall balance of benefit to risk for the drug, and to provide an adequate basis for an application to market a product. In general approximately 3,000 patient years exposure data derived from phase II and III clinical trial is required to support an application for consent to market a new medicine.

In addition, there can be Phase IV trials, which are post-marketing studies to gather additional information about the drug's risks, benefits, and optimal use.

CloningNew medicine iconApplications or research involving new organisms icon.

Cloning refers to producing a genetic copy or an organism. This can be by a natural process (such as grafting or the growing of plant cuttings, or by the production of identical twins in animals), or by laboratory manipulation, such as through the transfer of a cell nucleus into a cell lacking a nucleus (nuclear transplantation). Human reproductive cloning refers to making a whole person using cloning. This is banned in New Zealand, and there are no reliable reports that it has been achieved anywhere in the world to date. In contrast, a range of animal species (eg mice, sheep, cows and cats) have been cloned. Human therapeutic cloning refers to using cloning to create an embryo that is not allowed to develop into a whole human, but the embryo is used as a source of stem cells or other cells to help treat medical disorders. New Zealand has not banned human therapeutic cloning.

Containment Facility Applications or research involving new organisms icon.

A containment facility is a room, building or enclosed area registered as a containment facility under the Biosecurity Act 1993, or a facility which complies with the controls imposed by an approval granted under any of sections 42, 42A, 42B, or 45 of the HSNO Act.

Containment facilities are to prevent the escape of organisms into the wider environment. They can include laboratories, glasshouses, zoos, aquaria and research farms. The containment facility must be appropriate for the type of organism. To contain new organisms the containment facilities must be formally inspected and registered by MAF. MAF produces standards describing what is required for containment facilities. Containment Standards for microorganisms and cell cultures, invertebrates, vertebrate laboratory animals, zoo animals and plants, and for the field testing of farm animals can be found on the MAF BNZ website.

Containment structure Applications or research involving new organisms icon.

Means a containment facility that is a vehicle, room, building, or other structure, set aside and equipped for the development of genetically modified organisms. For new organisms in New Zealand containment structures are usually registered as Physical Containment facilities ranging from level 1 (lowest) to 4 (highest). The requirements for these are listed in MAF's containment standards (see Containment facility above). Most research laboratories will be either Physical Containment level 1 or 2. Farms and other open air facilities are not defined as containment structures.

Controls Applications or research involving new organisms icon.

Controls are any obligations or restrictions imposed on any new organism or hazardous substance, or on any person in relation to any new organism or hazardous substance, for the purposes of controlling the adverse effects of that organism or hazardous substance on people or the environment. Controls?may involve specifying where the new organism can be held, who can use the organism or substance, how and when the organism or substance is to be disposed of, or any other controls that ERMA sees fit.

Field test Applications or research involving new organisms icon.

Field tests are a form of containment and are for the carrying on of trials on the effects of the organism under conditions similar to those of the environment into which the organism is likely to be released, but from which the organism, or any heritable material (such as pollen or seeds) arising from it, could be retrieved or destroyed at the end of the trials. Note that this means that if viable pollen or seeds from genetically modified plants are intended to be freely released into the environment then a field test approval is not appropriate - an application for conditional or full release would be necessary. However, field tests could be conducted if the plants were not allowed to flower or there was an effective method for preventing dispersal of heritable material.

Food Standards

Food Standards list conditions under which foods must be processed, sold, etc. For more information seed the Food section of the Regulatory Wayfinder.

Genetically modified organism Applications or research involving new organisms icon.

Genetically modified organism (GMO) means any organism in which any of the genes or other genetic material:

  • Have been modified by in vitro (“laboratory”) techniques; or
  • Are inherited from any genes or other genetic material which has been modified by in vitro techniques

See also Low risk GMOs.

Hazardous substance Applications or research involving new organisms icon.

Hazardous substance means a substance with one or more of the following intrinsic properties:

  • Explosiveness
  • Flammability
  • A capacity to oxidise
  • Corrosiveness
  • Toxicity (including chronic toxicity)
  • Ecotoxicity
Institutional Biological Safety Committee Applications or research involving new organisms icon.

An Institutional Biological Safety Committee (IBSC) is a committee established by a research organisation or group of organisations that have delegated powers of decision from the Authority to assess and approve rapid assessment applications for the importation and development of low risk GMOs. Committees with such delegated decision-making powers are regularly audited by ERMA New Zealand to ensure that applications are properly prepared and decisions are consistent with the Act and the decision-making methodology.

An IBSC must have members with a specified range of skills and knowledge, and must be aware of the relevant HSNO regulations and decision-making methodology. The IBSC decisions are included in ERMA New Zealand’s register and in “The Bulletin” that ERMA New Zealand publishes every month. More information on IBSCs can be found on ERMA New Zealand’s website.

Low risk GMOs Applications or research involving new organ?sms icon.

Low risk GMOs are genetically modified organisms that meet the HSNO (Low-Risk Genetic Modification) Regulation requirements and are eligible for rapid assessment by ERMA or IBSCs. Such genetically modified organisms must be contained within a registered containment facility meeting the requirements of Physical Containment level 1 or 2. Genetically modified organisms that do not meet the “low risk” requirements are not necessarily “high risk” genetically modified organisms.

Living modified organism Applications or research involving new organisms icon.

'Living modified organism' means any living organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology.

Minimum Standards Applications or research involving new organisms icon.

Minimum Standards relate to the HSNO Act. The Environmental Risk Management Authority shall decline an application for import or release of a new organism if the new organism is likely to

  • Cause any significant displacement of any native species within its natural habitat; or
  • Cause any significant deterioration of natural habitats; or
  • Cause any significant adverse effects on human health and safety; or
  • Cause any significant adverse effect to New Zealand's inherent genetic diversity; or
  • Cause disease, be parasitic, or become a vector for human, animal, or plant disease, unless the purpose of that importation or release is to import or release an organism to cause disease, be a parasite, or a vector for disease.
Ministerial Council

The Ministerial Council is the Australia & New Zealand Food Regulation Ministerial Council. This consists of the State and Territory Ministers of Food in Australia, and the New Zealand Minister of Food. This Council sets policy in relation to food standards, and approves draft food standards or variations to standards.

New Organism New medicine iconApplications or research involving new organisms icon.

A New Organism is:

  • an organism belonging to a species that was not present in New Zealand immediately before 29 July 1998
  • An organism belonging to a species, subspecies, infrasubspecies, variety, strain, or cultivar prescribed as a risk species, where that organism was not present in New Zealand at the time of promulgation of the relevant regulation
  • An organism for which a containment approval has been given under this Act
  • An organism for which a conditional release approval has been given
  • A qualifying organism approved for release with controls
  • A genetically modified organism
  • An organism that belongs to a species, subspecies, variety, etc that has been eradicated from New Zealand.
Outdoor development Applications or research involving new organisms icon.

Outdoor development is a form of containment for new organisms applicable under the HSNO Act. It means that the new organisms are contained ?nd controlled, but not in a building or facility that is fully enclosed with walls, roof and floor. For example, if genetically modified cattle are to be developed for research purposes then the applicant could apply to keep them in a highly secure research farm rather than a fully enclosed building. A normal farm would not be considered an outdoor containment facility in this case. Outdoor development is different from field tests based on the purpose of the research. In practice, though, the types of controls may not be very different.

Release—conditional Applications or research involving new organisms icon.

A conditional release is an approval for release into the environment given under the HSNO Act with controls or conditions attached to the release. An organism approved for conditional release remains a new organism under the HSNO Act.

Release—full Applications or research involving new organisms icon.

A full release under the HSNO Act allows the organism to be grown or able to move within New Zealand free of any restrictions other than those imposed in accordance with the Biosecurity Act 1993 or the Conservation Act 1987.

Stem cell New medicine icon

A stem cell is an undifferentiated cell that has the potential to give rise to daughter cells of other cell types (such as blood cells). They are of interest as one means of potentially being able to be used to treat some medical disorders.

Stem cells can be obtained from embryos (embryonic stem cells), fetuses (fetal stem cells), or children or adults (adult stem cells). Different countries are taking different approaches to regulating what types of stem cells are able to be used. In New Zealand the collection and use of any type of human stem cell requires ethical approval.

Unwanted organism Applications or research involving new organisms icon.

An unwanted organism means any organism that a chief technical officer (who can be appointed by the Chief Executive of MAF, Department of Conservation, Ministry of Health, or other relevant agency) believes is capable or potentially capable of causing unwanted harm to any natural and physical resources or human health. A new organism that has escaped from containment is also considered an unwanted organism and may be subject to eradication or other form of management.

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