Abstract
In Australia, the Therapeutic Goods Administration (TGA) is responsible for the regulation of therapeutic goods under the provisions of the Therapeutic Goods Act 1989. Health care policy in Australia is the collective responsibility of the governments of the Australian federation. In 2002, the federation directed the TGA to develop a suitable regulatory model for human cell, tissue, and emerging biological therapies. As the process for developing the model evolved, a parallel process was begun to establish a common regulatory agency for Australia and New Zealand through a joint Australia and New Zealand Therapeutic Products Authority (ANZTPA). The particular problems of regulating complex biological therapeutics, subject to intense governmental and public interest, within an agency structured and skilled based on the needs of the traditional pharmaceutical sector will be described in this chapter.
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Notes
- 1.
As governments, including that of Australia, have tended to introduce cost-recovery from the regulated sector as a way of paying for regulation, the concept of the public as the regulator’s client has, perforce, had to take a modified role.
- 2.
The States of New South Wales, Victoria, Queensland, South Australia, Western Australia, and Tasmania, and the Northern Territory and the Australian Capital Territory.
- 3.
As an example, it is part of the Australian policy apocrypha that a decision to allow the importation of apples from New Zealand has been “maturing” for 80 years.
- 4.
Which consists currently of a center-left government opposed to a center-right opposition. The left-wing Green party opposes this policy, For a brief period during 2007-08, all the jurisdictions were governed by the centre-left Labour Party, a situation which did not enhance significantly the level of national consensus on health policy.
- 5.
Go to http://www.tga.gov.au for more information on the Australian regulatory system.
- 6.
Regrettably, Australia is 12th out of a list of 14 OECD countries in terms of organ donation levels. See MJA 2006; 185(5): 250–254.
- 7.
Examples include facilities engaged in developing anti-cancer cell-based vaccines where the Phase I subjects are patients with the disease.
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Farrugia, A. (2009). A Regulatory System for Cell and Tissue Therapies: Proposed Approach in Australia. In: Gee, A. (eds) Cell Therapy. Springer, Boston, MA. https://doi.org/10.1007/b102110_3
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DOI: https://doi.org/10.1007/b102110_3
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