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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
2. Cost recovery model
2.1. Outputs and business processes of the activity
Blood, blood components and plasma derivatives are regulated under 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' does 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 involves the use of tissues as therapeutic goods, while cell therapy products involves 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
Some examples of cell therapies currently being used, or currently under development, are:
- chondrocytes used for cartilage regeneration
- isolated pancreatic islet cells for the treatment of diabetes
- mesenchymal progenitor cells for the treatment of musculoskeletal defects and in a range of other clinical applications such as cardiovascular repair
2.1.1 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).
2.1.2 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.
2.1.3 Risk management
TGA works with consumers, health professionals, industry, and its international counterparts in order to effectively regulate therapeutic products, many of which are increasingly complex as a result of rapid scientific developments.
The TGA applies a risk management approach to regulating therapeutic goods by:
- identifying, assessing, and evaluating the risks posed by therapeutic goods before they can be approved for use in Australia (pre-market assessment or evaluation);
- identifying, assessing, and evaluating the risks posed by manufacturing processes before a manufacturer is issued with a licence to manufacture therapeutic goods (licensing of manufacturers); and
- identifying, assessing, and evaluating the risks that may arise following approval of the product and licensing of the manufacturer (post market surveillance)
2.2 Reform of business processes
The TGA has started work on a series of reforms to improve understanding of the regulatory processes by its stakeholders; significantly enhance post market and surveillance capability and enhance public trust in the safety and quality of therapeutic goods. For blood, and biologicals, these reforms aim to:
- Provide more information on the regulatory framework so that stakeholders understand regulatory processes and requirements
- Improve the usability, accuracy and consistency of guidelines
- Improve the management of adverse event reporting in support of consumer safety
- Promote the distribution of therapeutic goods safety information so that consumers are alert to warning signals
- Align recall procedures including communication of alerts to the public and health professionals
- Develop technology to support business processes
2.3. Activity level assumptions
2.3.1. Inclusion on the ARTG
The TGA estimates demand for its services based on prior years' volumes which are adjusted for forecast changes in the industry operations and changes in the regulatory framework and/or service delivery models.
2.3.2. Compliance monitoring and enforcement
Estimates for the number of products on the register incorporate expected cancellations and new goods. New goods estimates include the outcomes of work on assessing products for registering on the ARTG.
Tables 1-3 contain activity level assumptions based on the number of premises for manufacture of blood, blood components and human tissues; human cell and tissue therapy products; and good manufacturing practice inspections for manufacturers of human cell and tissue therapy products that are subject to annual licence charges and/or inspection fees.
|Number of premises||2013-14||2014-15|
|Blood Primary Site||8||5|
|Blood Secondary Site||78||80|
|Single Step and Single Human Tissue||14||14|
Audits of manufacturers of primary blood sites are entitled to 3 free inspections within a 3 year period under the terms of their annual licence charge.
|Class 2 biological products||5||2|
A sponsor can seek exemption from the liability to pay an annual charge for an entry on the ARTG if the therapeutic good qualifies for low value turnover (LVT) that is a product with a turnover of not more than 15 times the applicable annual charge.
|Domestic subsequent manufacturing audit||1,382||1,400|
2.4. Design of cost recovery charges
TGA recovers the cost of its regulatory activities through fees and charges for services provided to product manufacturers and sponsors.
Fees are used to recover the cost of the evaluation required before a product can be listed.
Fees are also charged to cover the cost of manufacturing compliance inspections except where the costs have been included in annual licence charges, e.g. for primary blood site audits.
Annual charges are payable by manufacturers that produce human tissues (biologicals), and for products registered on the ARTG.
Annual charges are used to recover the cost of activities, usually post market, where:
- they cannot reasonably be assigned to individual manufacturers and/or sponsors
- they maintain the integrity of the regulated industry to the benefit of all manufacturers and/or sponsors
- assigning costs to individual manufacturers and/or sponsors would deter manufacturers and/or sponsors from disclosing important public health information, such as reporting adverse events
2.4.3. Reform program
The implementation of the reform program is scheduled to continue through to mid 2015-16. As changes in regulatory activities are implemented, fees and charges will be adjusted to ensure that they continue to accurately reflect the costs of underlying activities.
For the 2014-15 financial year, fees and charges were indexed by 2.4% which is a 50:50 composite of the Australian Bureau of Statistics Consumer Price Index and the Wage Price Index.
2.5. Fees and charges
|Evaluation fees - per submission for blood, blood components and human tissues||Pages||2013-14
|Page counts - Blood Plasma Master File & Blood Technical Master File||1 - 10||1,180||1,210|
|11 - 50||10,200||10,400|
|51 - 100||22,700||23,200|
|101 - 1000||30,500||31,200|
|1001 - 3000||47,600||48,700|
|3001 - 4000||63,300||64,800|
|Good manufacturing practice (GMP) inspections||2013-14
|GMP inspection of primary site of Manufacturers of Blood and Blood Components except Haematopoietic Progenitor Cells||Hourly rate per inspector $810||Hourly rate per inspector $830|
|GMP inspection of site other than primary site of Manufacturers of Blood and Blood Components except Haematopoietic Progenitor Cells||Hourly rate per inspector $600||Hourly rate per inspector $615|
|GMP inspection of Manufacturers of Haematopoietic Progenitor Cells||Hourly rate per inspector $600||Hourly rate per inspector $615|
|GMP Audit of Manufacturers of Human Tissues||Hourly rate per inspector $600||Hourly rate per inspector $615|
|Application and notification fees for human cell and tissue therapy products||2013-14
|Application for manufacturing licence||980||1,005|
|Application for variation||980||1,005|
|Application for inclusion of a Class 1,2,3,4 biological||980||1,005|
|Notification Fee for a biological (CTN)||310||315|
|Evaluation fees for human cell and tissue therapy products||2013-14
|Evaluation of dossier for a Class 2 biological||65,200||66,800|
|Evaluation of dossier for a Class 3 biological||130,400||133,500|
|Evaluation of dossier for a Class 4 biological||211,900||217,000|
|Class 2 biological||5,980||6,125|
|Variation Class 3 and 4||15,700||16,100|
|Major Variation Class 3 and 4||31,000||31,700|
|Evaluation of an ingredient/component||21,100||21,600|
|Evaluation Clinical Trial Exemption||23,500||24,100|
|Inspection fees for human cell and tissue therapy products||2013-14
|Domestic initial manufacturing inspection||19,400||19,900|
|Domestic subsequent manufacturing inspection||14,700||15,100|
|Overseas initial manufacturing inspection||19,400||19,900|
|Overseas subsequent manufacturing inspection||14,700||15,100|
|Inspection Fee - in addition to initial or subsequent inspection fee outside Australia||600||615|
|Primary site of Manufacturers of Blood and Blood Components except Haematopoietic Progenitor Cells||144,700||148,200|
|Additional fixed site (non-mobile) of Manufacturers of Blood and Blood Components except Haematopoietic Progenitor Cells||7,120||7,290|
|Manufacturing premises of Haematopoietic Progenitor Cells||6,230||6,380|
|Single step and single human tissue of manufacturers of Human Tissues||6,230||6,380|
|Two or more steps of manufacturers of Human Tissues||12,100||12,400|
|Annual charge for Class 1 biological||600||615|
|charge for Class 2,3,4 biological||5,980||6,125|