What is regulated?
Biotechnology is regulated in a variety of ways, depending on what is involved. You can find out more about what is regulated in New Zealand in these pages. Some types of biotechnology are not regulated to the same extent as others. For example, genetic modification of microbes, plants and animals often requires greater regulatory scrutiny than use of non-modified organisms.
The Interactive Guide provides graphical overviews of regulatory steps, while the following pages provide more detail. It is recommended that you talk with the appropriate regulatory agencies and/or others with first-hand experience of the process before submitting applications.
The main areas of regulation discussed here cover:
Importation and development of “novel” foods
Development and use of veterinary medicines and pesticides, herbicides, etc- Research involving genetic modification, other new organisms and hazardous substances
Development and use of human medicines, therapeutics and medical device- Animal welfare and human ethics
These areas can overlap or interact with each other. For example, developing genetically modified lab mice will need to be looked at by two different regulating bodies (those considering animal welfare and genetic modification issues, respectively).
This site covers six main pieces of legislation:
- Agricultural Compounds and Veterinary Medicines Act 1997
- Animal Welfare Act 1999
- Biosecurity Act 1993
- Food Act 1981
- Hazardous Substances and New Organisms Act 1996
- Medicines Act 1981
The key issues that these pieces of legislation address are illustrated here . Some of the Acts overlap in their areas of interest but they are not intended to duplicate the same regulatory requirements. New Zealand is distinct from many other countries in that some of its legislation requires cultural and other societal factors to be considered alongside scientific, economic and ethical factors. The Hazardous Substances and New Organisms Act is an example of this.
