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)
- 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.
- criticalCWLTHMaintain controlled drugs register (Schedule 8 / 9)
Pharmacies + medical practices must keep contemporaneous register of S8/S9 medicines.
- highCWLTHComply with the Therapeutic Goods Advertising Code
Advertising of therapeutic goods to consumers must comply with the TGA Advertising Code and prohibited representations.
- highCWLTHTherapeutic Goods Advertising Code
Advertising of therapeutic goods to AU consumers must comply with TGA Advertising Code.
Recent TGA enforcement
Scope topics
Parent legislation
Source: regulator's own website. Rules Mate links and summarises — we don't republish full statutory text.