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Cost recovery implementation statement: Blood, blood components and biologicals (human cell and tissue therapies), From 1 July 2015
Version 1.0, July 2015
Purpose of the Cost Recovery Implementation Statement (CRIS)
This CRIS provides information on how the Therapeutic Goods Administration (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 financial and non-financial performance information and contains financial forecasts for 2015-16. The TGA will maintain the CRIS until the activity or cost recovery for the activity has been discontinued.
Description of the activity
The TGA forms a part of the Department of Health and is responsible for evaluating the safety, quality and efficacy of medicines, medical devices and biologicals available for supply in, or export from Australia.
The TGA approves and regulates products based on an assessment of risks against benefits. All therapeutic goods carry potential risks, some of which are minor, some potentially serious. The TGA applies scientific and clinical expertise to its decision-making to ensure that the benefits of a product outweigh any risk. The level of TGA regulatory control increases with the level of risk the medicine or device can pose. The risk-benefit approach assures consumers that the products they take are safe for their intended use, while still providing access to products that are essential to their health needs.
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.
Outputs and business processes of the activity
Blood, blood components and plasma derivatives are regulated under theTherapeutic Goods Act 1989 (the Act). Plasma derivatives are prescription medicines subject to full regulation, including compliance with set standards, licensing of manufacture and inclusion in the ARTG after review of manufacturing, pre-clinical and clinical data. Under the Act 'blood' means whole blood extracted from human donors and 'blood components' means therapeutic components that have been manufactured from blood (including red cells, white cells, progenitor cells, platelets and plasma). 'Blood components' do not include products derived through fractionation of plasma.
Some blood and blood components are exempt from regulation by TGA including blood and blood components that are:
- collected by a medical practitioner in the course of medical treatment and for the purposes of diagnosis or testing for a medical condition
- manufactured by a medical practitioner for therapeutic application to a particular patient under the practitioner's care
- manufactured by a blood collection centre for a medical practitioner for therapeutic application to a particular patient under the practitioner's care
Manufacturers of blood components are required to demonstrate compliance with manufacturing principles equivalent to the Australian Code of Good Manufacturing for human blood and blood components, human tissues and human cellular therapy products (2013) and to submit a technical master file which demonstrates compliance to relevant standards.
Biologicals include human tissue and cell therapy products. Tissue therapy products involve the use of tissues as therapeutic goods, while cell therapy products involve the use of isolated living cells either as therapeutic goods or as replacements for cells that are defective or deficient in particular disorders.
Some examples of tissue therapies currently being used are:
- Skin replacement after severe burns
- Transplantation of heart, kidney, liver, lung or pancreas
- Bone, tendons and ligaments to repair injuries
- Heart valves to replace defective heart valves
- Corneas to restore eyesight
Inclusion on the ARTG
The regulatory activities for biologicals involve the following registration and approval activities:
- Management of applications for inclusion in the ARTG
- Sponsors of Class 1 biologicals are required to attest compliance with relevant mandatory standards
- Class 2, 3 and 4 biologicals undergo pre-market evaluation prior to ARTG inclusion
- Highly manipulated Class 3 and 4 biologicals are subject to the highest levels of pre-market evaluation
- Manufacturers of Class 2, 3 and 4 biologicals are required to demonstrate compliance with manufacturing principles equivalent to the Australian Code of Good Manufacturing for human blood and blood components, human tissues and human cellular therapy products (2013).
Compliance monitoring and enforcement
- Post-market controls include ongoing manufacturing inspections, managing adverse event reporting, investigations and recalls.
- The TGA also provides information and support to the regulated industry and consumers and is responsible for the maintenance of the regulatory framework.