20 Years of Legislation - How Australia Has Responded to the Challenge of Regulating Genetically Modified Organisms in the Clinic.
- 2022-05-10
- Frontiers in medicine 9
- Gabrielle M O'Sullivan
- Joshua G Philips
- Heidi J Mitchell
- Michael Dornbusch
- John E J Rasko
- PubMed: 35620726
- DOI: 10.3389/fmed.2022.883434
Study Design
- Type
- Review
•In contrast to the prior voluntary system, since 2001, gene technology in Australia has been regulated under a legislated national Gene Technology Regulatory Scheme which is administered by the Gene Technology Regulator.•The Scheme provides science-based assessment of the potential risks of gene technology to the health and safety of people and the environment.•It complements the role of the Australian Therapeutic Goods Administration which regulates all therapeutic products in Australia to ensure they are safe and effective.•Recent reforms to the Scheme contribute to, and anticipate, the continued safe development and delivery of gene-based human therapeutics in Australia as a successful model for other jurisdictions.
Research Insights
The frequency of defecation was significantly increased compared with placebo.
- Effect
- Beneficial
- Effect size
- Small
Bifidobacterium longum iVE-15 supplementation significantly improved gastrointestinal symptoms, especially abdominal pain and distension, in healthy adults.
- Effect
- Beneficial
- Effect size
- Small