TGA
Therapeutic Goods Administration
Regulator of therapeutic goods — medicines, medical devices, biologicals, and blood products. Administers the Therapeutic Goods Act and ARTG.
5
Obligations enforced
1
Enforcement actions tracked
6
Scope topics
Obligations enforced by TGA (5)
- criticalCWLTHMaintain controlled drugs register (Schedule 8 / 9)
Pharmacies + medical practices must keep contemporaneous register of S8/S9 medicines.
- criticalCWLTHConduct post-market surveillance of therapeutic goods
ARTG-included goods must be monitored post-market for safety + performance.
- criticalCWLTHIn-vitro diagnostic medical device classification + ARTG
IVDs classified by risk (Class 1-4); ARTG inclusion required for supply.
- highCWLTHTherapeutic Goods Advertising Code
Advertising of therapeutic goods to AU consumers must comply with TGA Advertising Code.
- highCWLTHComply with the Therapeutic Goods Advertising Code
Advertising of therapeutic goods to consumers must comply with the TGA Advertising Code and prohibited representations.
Recent TGA enforcement
Scope topics
Parent legislation
Source: regulator's own website. Rules Mate links and summarises — we don't republish full statutory text.