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Cost recovery impact statement: Blood, blood components and biologicals (human cell and tissue therapies), 1 July 2014 - 30 June 2015
Version 1.0, June 2014
1.1. Purpose of the Cost Recovery Impact Statement (CRIS)
The CRIS provides key information on how the TGA implements cost recovery of activities associated with the inclusion of biologicals (human cell and tissue therapies) onto the Australian Register of Therapeutic Goods (ARTG) and the regulation of blood, blood components and biologicals through inspection and licensing of manufacturers. It covers the ongoing monitoring and licensing of blood, and biologicals. It also reports on financial and non-financial performance of these activities and contains up-to-date financial forecasts. The TGA will maintain the CRIS until the activity or its cost recovery has been discontinued.
This CRIS will apply from July 2014 to June 2015.
1.2. Description of the activity
The TGA forms a part of the Department of Health, responsible for evaluating the safety, quality and efficacy of medicines, medical devices and biologicals available for supply in, or export from Australia. The TGA recovers the full costs of its regulatory activities through fees and charges imposed on sponsors and manufacturers of therapeutic products.
The Australian community has an expectation that therapeutic products in the marketplace are safe and of high quality, to a level equal to that of countries with comparable standards.
Australia has a risk based system where the level of regulatory control of a therapeutic product is based on the relative safety of the product and the seriousness of the condition for which it is intended to be used. Products are reviewed at a level consistent with the risk associated with their use in the community.
Most products for which therapeutic claims are made must be assessed and entered on the ARTG before they can be marketed in Australia. The ARTG keeps a record of products that are approved for marketing, the ingredients contained in each product, the therapeutic claims made for medicines and biologicals, and the intended use of medical devices. Not all human cell and tissue therapies available in Australia are regulated by the TGA.
The TGA also regulates blood components. These products are not generally included on the ARTG; they are regulated through inspection of manufacturers based on an assessment of their ability to comply with relevant manufacturing standards.
1.3. Australian Government cost recovery framework
Cost recovery involves the government entities charging individuals or non-government organisations some or all of the efficient costs of a specific government activity. This may include goods, services or regulation, or a combination of these. The Australian Government Cost Recovery Guidelines (CRG) set out the overarching framework under which government entities design, implement and review cost recovered activities.
1.4. Policy and statutory authority to cost recover
1.4.1. Government policy approval to cost recover the activity
In the 1997-98 Budget1, the Government decided to cost recover 100 percent of all TGA's activities by 1998-99. This policy authority encompasses recovering expenses incurred by the TGA in regulating blood, and biologicals.
1.4.2. Statutory authority to impose cost recovery charges
The Therapeutic Goods Act 1989 (the Act) provides a legal authority for the TGA to charge for its regulatory activities within the scope of the Act on a cost recovery basis. Applicable fees and charges are prescribed in regulations made under the Act and the Therapeutic Goods (Charges) Act 1989 (the Charges Act). These regulations are included in the Therapeutic Goods (Charges) Regulations 1990 and the Therapeutic Goods Regulations 1990.
- 1997-98 Budget Paper 2, Revenue Measures, Other Measures p 203.