Commonwealth Therapeutic

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. 

The Commonwealth Government has agreed to establish a joint therapeutic products regulatory agency with the New Zealand Government,... 

The Therapeutic Substances Act 1937 gave the Minister for Health power to control the import and export of substances declared to be therapeutic substances in the Commonwealth Gazette. 

The Therapeutic Substances Act 1953 repealed the 1937Act and gave the Commonwealth control of the import into Australia and interstate trading of therapeutic substances and controlled therapeutic substances (drugs of addiction). It came into operation in 1956 and was administered by the Therapeutic Substances Branch of the Department of Health. 

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. 

By the late 1980s, it had also become clear that reliance on a combination of Commonwealth and State legislation was not the best way to ensure that desired standards were met. There were many complaints about loopholes and lack of uniformity. The way forward came from an unexpected source, namely, a court case that confirmed that the Commonwealth Government has powers over all corporations, and thus these powers could be used in relation to therapeutic goods matters even if they occurred within one State. 

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. 

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. 

In 1998, the Commonwealth Government introduced TGPs, a form of reference pricing, to certain therapeutic drug classes listed on the Schedule of Pharmaceutical Benefits - H2 receptor antagonists, ACE inhibitors, HMG CoA... 

The NDPSC decisions in relation to the SUSDP have no force in Commonwealth law. However, State legislation refers to or reflects the SUSDP (occasionally with some differences in some States) and may impose warning statements and other labelling and packaging requirements additional to those covered by Commonwealth legislation and associated Therapeutic Goods Orders (TGOs). 

Commonwealth Department of Health. Standard for Sterile Therapeutic Goods Therapeutic Goods Order No. 11, Austrahan Government Publishing Service Canberra, 1984. 

Discussions on Trans-Tasman Mutual Recognition are continuing between Medsafe and the Therapeutic Goods Administration (TGA) of the Commonwealth Department of Human Services and Hesilth in Australia. A formal consultation process will extend to industry groups, consumers and other interested parties in due course. 

Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95). Annotated with TGA comments. Therapeutic Goods Administration [TGA] (Australia), Commonwealth Department of Health and Aged Care. The TGA has adopted CPMP/ICH/ 135/95 in principle but has recognised that some elements are, by necessity, overridden by the National Statement (and therefore not adopted) and that others require explanation in terms of local regulatory requirements , July 2000. http //www.health.gov.au/tga/docs/html/ ichl3595.htm. 

D. Abraham, R. Danso-Danquah, T. Boyiri, I. Nnamani, C. Wang, M. Gerber, S. Hoffman and G. Joshi, Alios Therapeutics, Inc. Virginia Commonwealth University, WO 1999/048490. 

Experimental Therapeutics, Mr. William H. Goodwin and Mrs. Alice Goodwin and the Commonwealth Foundation for Cancer Research, and Experimental Therapeutics Center of MSKCC. 

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