International perspective
How do other countries regulate biotechnology?
Generally the regulation of human and veterinary medicines, and food in many other countries is substantially similar to the regulatory processes in New Zealand. Australia and New Zealand are closely aligned with respect to human medicine and food regulation, although Australia can have both Federal and State regulatory bodies.
Animal welfare is also regulated similarly in many countries, although there are differences in what types of animals are covered.
Where countries differ most is in how genetically modified organisms (GMOs) are regulated. New Zealand has one of the most comprehensive regulatory regimes for GMOs, and includes requirements to take account of cultural, ethical and spiritual concerns.
Links to some other countries' regulatory bodies are given below.
Australia
Canada
European Union
United Kingdom
USA
Marketing medicines overseas
International Agreements
Australia
- The Office of the Gene Technology Regulator regulates the use of GMOs in Australia.
- The Therapeutic Goods Administration regulates medicines and medical devices.
- Food Standards Australia New Zealand regulates foods in Australia as well as in New Zealand.
- The Australian Pesticides and Veterinary Medicines Authority is responsible for regulation of pesticides and veterinary medicines in Australia.
- Each State has its own animal welfare legislation. More information is available from the Animal Ethics Infolink. Australia has a code of practice for the care and use of animals for scientific purposes.
Canada
- BioRegulations is a portal site that provides information on how Canada regulates biotechnology applications.
- The Canadian Food Inspection Agency regulates non-medical biotechnology-related products, such as plants with novel traits.
- Health Canada has regulatory oversight of the Canadian food and drugs legislation and the pest management products legislation.
- Each State has its own animal welfare legislation. More information is available from the Canadian Council on Animal Care.
European Union
- The European Food Safety Authority assesses the safety of human and animal food.
- The European Medicines Evaluation Agency assesses the safety of human and animal medicines.
United Kingdom
- The United Kingdom Biotechnology Regulatory Atlas provides a very good overview of the UK's regulatory requirements for biotechnology. (Note that sometimes this site may be slow or difficult to access)
- The Department for Environment Food and Rural Affairs is responsible for regulation of deliberate release of GMOs in the UK.
- The Health and Safety Executive has oversight of contained use of GMOs.
- The Medicines and Health Care Products Regulatory Agency regulates medicines, healthcare products and medical equipment.
- Animal welfare of animals used for scientific purposes is covered by the Animals (Scientific Procedures) Act, and an Animal Procedures Committee based in the Home Office oversees use of animals in research.
United States of America
- The Food and Drug Administration regulates medicines and human foods.
- The Environmental Protection Agency develops and enforces environmental regulations, including those involving biopesticides used in GM plants.
- The Biotechnology Regulatory Services programme of the Animal and Plant Health Inspection Service (APHIS), part of the US Department of Agriculture, regulates the field testing, movement, and importation of GMOs that are known to be, or could be plant pests.
- The Center for Veterinary Biologics, also part of APHIS, regulates veterinary biologics (vaccines, diagnostic tests and other products derived from biological sources).
- US animal welfare regulations are less comprehensive than the other countries listed here because US legislation only covers mammals and birds, and the use of mice and rats in research are not regulated by this legislation. Further information is available from the animal welfare information center.
Marketing medicines overseas
If you are interested in marketing a medicine in other countries, the relevant national regulatory agencies have guidance material.
The Australian Therapeutic Goods Administration has regulatory guidelines for prescription medicines, over-the-counter medicines, complementary medicines and medical devices.
The European medicines agency also has a range of guidance material.
The US Food and Drug Administration has guidelines for drugs, biologics (eg vaccines and blood products), and medical devices.
International Agreements
The Cartagena Protocol on Biosafety is an international agreement that New Zealand has ratified. This Protocol covers trade in “living modified organisms”, which is broader than New Zealand's definition of a GMO. The Biosafety Protocol establishes a procedure for ensuring that countries are provided with the information necessary to make informed decisions before agreeing to the import of living modified organisms into their territory. More information on the biosafety protocol is available in the Biosafety and the Environment booklet [20 pages, 1.27Mb, PDF].
See the new organisms section for information on what is required to export an LMO.
