Commonwealth Therapeutic Goods Act

Furthermore, Commonwealth legislation was reviewed to give the Commonwealth powers to require companies to submit specified data to establish the quality, safety and efficacy of imported therapeutic goods. The resultant Therapeutic Goods Act 1966 provided the basis for the regulation of pharmaceuticals in Australia for over 20 years. 

The Therapeutic Goods Act 1989 and Regulations came into effect on 15 Eebruary 1991, giving the Commonwealth more clearly defined regulatory authority. It changed the focus of control over therapeutic goods from the point of importation to the point of supply of the goods. 

The Commonwealth Therapeutic Goods Amendment (Medical Devices) Act 2002 and the Therapeutic Goods (Medical Devices) Regulations 2002 came into effect from October 2002. Under the... 

The Therapeutic Goods Administration (TG A), as part of the Commonwealth Department of Health, has the responsibihty for administering the Act. It applies a risk management approach to therapeutic goods regulation, which is intended to ensure public health and safety while minimising the regulatory burden and associated costs. 

Therapeutic Goods, in conjimction with the States. The Australian Recall Coordinator also liaises with the Commonwealth Minister responsible for Consumer Affairs in relation to safety-related recalls of therapeutic goods, which must be notified within 48 h, in accordance with the Trade Practices Act 1974. A mandatory recall of faulty goods may be enforced where safety is involved. 

---