New Zealand: Therapeutic / Stem Cell

HIGHLY REGULATED
Gene therapies for certain diseases permitted in New Zealand, but highly regulated.

Gene therapy permitted for diseases when the cause is a defect in a single pair of genes or in cancers, and when there is clear evidence that therapy may improve clinical outcomes. Gene therapy regulated under the Medicines Act and every gene therapy must be approved by the Gene Technology Advisory Committee (GTAC).

Therapies

  • Parkinson’s disease: US Food and Drug Administration approved the world’s first clinical trial using a gene therapy approach for Parkinson’s Disease, run by researchers at the University of Auckland.
  • Epilepsy: Gene therapy approaches currently being developed by researchers at the University of Auckland.

Regulatory Timeline

2018: The Research Ethics Guidelines define acceptable gene therapy programs for clinical and research use that allows gene therapy for diseases when the cause is a defect in a single pair of genes or in cancers, and when there is clear evidence that therapy may improve clinical outcomes.

2017: Royal Society of New Zealand releases Gene Editing in a Healthcare Context, which considers the social, cultural, legal and economic implications of gene-editing technologies for New Zealand and summarizes the current regulations for human gene editing.

2001: Royal Commission on Genetic Modification established, and issues a report detailing strict regulation of all gene therapies.

1996: The Environmental Protection Authority releases the Hazardous Substances and New Organisms (HSNO) Act 1996, establishing regulations for the creation and release of non-native (including genetically modified) organisms into New Zealand. The Royal Commission on Genetic Modification decided that research involving genetic modification of human cells is also covered by this Act.

1981: The Medicines Act, which regulates all drugs administered to humans, finalized.

Additional Resources

Click on countries (eg. Brazil, US) or regions (eg. European Union) to find what agricultural products or therapies are approved or in development and their regulatory status.

Hotspots Background

EUROPEAN UNION

 

Agricultural Gene Editing
- Crops / Food
- Animals

 

Human Gene Editing
- Therapeutic / Stem Cell
- Germline / Embryonic

 

Gene Drives

 

BRAZIL

 

Agricultural Gene Editing
- Crops / Food
- Animals

 

Human Gene Editing
- Therapeutic / Stem Cell
- Germline / Embryonic

 

Gene Drives

 

NEW ZEALAND

 

Agricultural Gene Editing
- Crops / Food
- Animals

 

Human Gene Editing
- Therapeutic / Stem Cell
- Germline / Embryonic

 

Gene Drives

 

UNITED STATES

 

Agricultural Gene Editing
- Crops / Food
- Animals

 

Human Gene Editing
- Therapeutic / Stem Cell
- Germline / Embryonic

 
 

Gene Drives

 

AUSTRALIA

 

Agricultural Gene Editing
- Crops / Food
- Animals

 

Human Gene Editing
- Therapeutic / Stem Cell
- Germline / Embryonic

 

Gene Drives

 

CANADA

 

Agricultural Gene Editing
- Crops / Food
- Animals

 

Human Gene Editing
- Therapeutic / Stem Cell
- Germline / Embryonic

 
 

Gene Drives