Jun. 18 at 7:01 AM
$EDIT
Australia regulates in vivo gene-editing products through two parallel frameworks:
1. Therapeutic Goods Administration (TGA) – oversees the clinical trial and therapeutic product aspects.
2. Office of the Gene Technology Regulator (OGTR) – oversees dealings involving genetically modified organisms and gene technology where applicable. The TGA notes that OGTR approval may be required before or alongside TGA processes.
For therapies involving genetic modification inside the body (in vivo), including CRISPR-based treatments, Australia classifies them as prescription medicines, not biologicals. The TGA explicitly lists CRISPR and other gene-editing technologies used in vivo in this category.
Australia’s CTN pathway allows ethics committees and institutions to play a major role in trial oversight, often enabling earlier clinical starts than some other jurisdictions while still requiring compliance with national regulations and safety standards.
