Version 1.0, June 2014
Version | Description of change | Author | Effective date |
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V1.0 | Original publication | Office of Corporate Services/ Office of Medicines Authorisation | 1 July 2014 |
© Commonwealth of Australia 2014
This work is copyright. You may download, display, print and reproduce the whole or part of this work in unaltered form for your own personal use or, if you are part of an organisation, for internal use within your organisation, but only if you or your organisation do not use the reproduction for any commercial purpose and retain this copyright notice and all disclaimer notices as part of that reproduction. Apart from rights to use as permitted under the Copyright Act 1968 or allowed by this copyright notice, all other rights are reserved and you are not allowed to reproduce the whole or any part of this work in any way (electronic or otherwise) without first being given specific written permission from the Commonwealth to do so. Requests and inquiries concerning reproduction and rights are to be sent to the TGA Copyright Officer, Therapeutic Goods Administration, PO Box 100, Woden ACT 2606 or emailed to <tga.copyright@tga.gov.au>.
Version 1.0, June 2014
The CRIS provides key information on how the TGA implements cost recovery of activities associated with the registration of prescription medicines onto the Australian Register of Therapeutic Goods (ARTG) and the ongoing monitoring and surveillance of prescription medicines included on the ARTG. The TGA will maintain the CRIS until the activity or its cost recovery has been discontinued. It also reports on financial and non-financial performance of prescription medicine 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.
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.
All prescription medicines imported into, supplied for use in, or exported from Australia must undergo a registration process and be included on the ARTG.
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 by the TGA at a level consistent with the risk associated with their use in the community.
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.
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 prescription medicines.
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.
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Australia has a two-tiered system for the regulation of medicines, higher risk medicines, such as prescription medicines, must be registered on the ARTG before they are made available for sale in Australia.
Prescription medicines are available from a pharmacist, supplied with a doctor's prescription. Otherwise, only authorised health care professionals can supply prescription medicines, such as in a hospital setting.
Examples include vaccines, blood pressure tablets, diabetes medications, contraceptive pills, antibiotics and strong pain killers.
There are some legal exemptions to the requirement for a prescription medicine to be registered on the ARTG. These are implemented through:
Before being registered on the ARTG prescription medicines are assessed for quality, safety and efficacy.
All applications for registration of prescription medicines must be preceded by a pre-planning submission form (PPF). TGA assesses all PPFs to ensure that application dossiers for registration on the ARTG contain all the appropriate and required information.
The information provided in the PPF allows the TGA to effectively assign resources for the evaluation process. If the PPF is insufficient for planning purposes or indicates that mandatory requirements have not been met, the TGA may deem the PPF to be ‘not effective’ and the application will not proceed to the dossier submission stage.
The data submitted with an application is divided into three types.
Once a product has been registered, the sponsor can make further applications to change the details of registration. Some examples of the types of change that might be applied for:
Before making a decision around the suitability of a prescription medicine for registration on the ARTG, the delegate may take into consideration independent expert advice provided by the Advisory Committee on Prescription Medicines.
Regulatory decisions in relation to new chemical entities or fixed dose combination products are published through the Australian Public Assessment Report (AusPAR).
Any person whose interests are affected by the decision may seek a reconsideration of the decision under section 60 of the Act.
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:
Regulatory decisions are made within a framework of guidelines. The guidelines must maintain currency with scientific and technical developments.
International regulators, or regulator groups such as International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), may publish guidelines that are reviewed and may be adopted by the TGA.
Medicines for export from Australia must be of a similar quality and safety standard as those supplied domestically. However, they are not required to comply with the labelling standards or advertising standards in force in Australia. Export only products are required to be listed (not registered) on the ARTG before export.
In the circumstances where patients need access to therapeutic goods that are not on the ARTG, access to the therapeutic good may be arranged through the Special Access Scheme (SAS).
TGA reviews each access under the SAS on a case by case basis.
TGA reviews the use of unapproved medicines to be made available to patients participating in a clinical trial.
Post-market activities undertaken in relation to prescription medicines include:
The TGA has continued to work on a series of reforms to improve understanding of 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 the prescription medicines sector these reforms aim to:
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.
Estimates for the number of products on the register incorporate expected cancellations and new additions.
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), which is a turnover of not more than 15 times the applicable annual charge for that therapeutic good.
2013-14 | 2014-15 | |
---|---|---|
Prescription medicines - biologics | 992 | 998 |
Prescription medicines - non-biologics | 13,110 | 14,556 |
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 premarket services performed. For registered prescription medicines, the fee structure is based on an application and evaluation fee. Fees are scaled to account for the effort undertaken with the highest fees applicable for evaluating a new chemical entity.
Fees are also charged when a sponsor requires a change to the information contained in the ARTG.
Annual charges are payable for prescription medicines that are registered on the ARTG.
Annual charges are used to recover cost of activities, usually post market, where:
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.
Fees and charges for the prescription medicine sector for 2014-15 are outlined below. Fees and charges that applied for the sector for 2013-14 are at Attachment A.
Registration fees | 2014-15 Application Fee $ |
2014-15 Evaluation Fee $ |
---|---|---|
New Chemical Entity | 44,200 | 177,200 |
New Chemical Entity of a medicine used as an ancillary medical component of a device (item 4(aa)(i) and 4(aa)(ii)) | 14,700 | 59,100 |
New Chemical Entity of a medicine used as an ancillary medical component of a device (item 4(aa)(iii)) | 29,500 | 118,000 |
Extension of indications | 26,300 | 105,300 |
Extension of indicators of a medicine used as an ancillary medical component of a device - chemistry, quality control and manufacturing or pre-clinical studies | 8,775 | 35,100 |
Extension of indicators of a medicine used as an ancillary medical component of a device - documentation mentioned in subparagraphs (i) and (ii) | 17,600 | 70,100 |
Major variations | 17,200 | 68,500 |
Major variation of a medicine used as an ancillary medical component of a device - chemistry, quality control and manufacturing or pre-clinical studies | 5,725 | 22,700 |
Major variation of a medicine used as an ancillary medical component of a device - documentation mentioned in subparagraphs (i) and (ii) | 11,500 | 45,800 |
New generic product | 17,000 | 67,600 |
Additional trade name | 2,785 | 11,200 |
Minor variations (Change in formulation, composition, design specifications, type of container or change of trade name). | 1,015 | 4,035 |
Variation fees | 2014-15 Application Fee $ |
2014-15 Evaluation Fee $ |
---|---|---|
Variations to a Register entry involving the evaluation of clinical, pre-clinical or bio-equivalence data, but not included in another fee category. Includes applications for changes to Product Information involving the evaluation of clinical, pre-clinical or bio-equivalence data. | 1,015 | 4,035 |
Variations to a Register entry involving the evaluation of only chemistry, quality control or manufacturing data. Includes applications for changes to Product Information involving the evaluation of only chemistry, quality control or manufacturing information. |
5,050 | |
Variations to a Register entry (requiring changes to Product Information) with no evaluation of data 'minor editorial changes' | 1,555 | |
Testing and provision of advice, requested from Pharmaceutical Benefits Program, prior to listing on Pharmaceutical Benefits Listing Program (*this item is inclusive of GST) |
2,040 (2,244*) |
Administrative fees | 2014-15 Fee $ |
---|---|
Correction of a Register entry | 1,555 |
Annual charges | 2014-15 Charge $ |
---|---|
Biological Medicines (Biologics) | 6,585 |
Non-Biologics | 3,955 |
Clinical trials | 2014-15 Fee $ |
---|---|
CTX 30 Days | 1,595 |
CTX 50 Days | 19,900 |
CTN | 330 |
CTN - more than one trialing body | 330 |
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The TGA external communication and education framework: Priorities and projects 2013-2015 describes the TGA's approach to providing:
It also details specific communication and education projects that will target consumers, health professionals or industry.
TGA consults with industry associations separately on regulatory matters and cost impacts relating to specific sectors. Industry associations are also consulted in the process of regulatory development and reform, and feedback is taken into account in developing regulatory implementation statements, and in developing cost recovery arrangements. Meetings are held with key industry representative bodies each year to discuss financial forecasts and as a part of the consultation process on cost recovery. The TGA also reports to stakeholders against a set of agreed Key Performance Indicators (KPIs).
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Total revenues are a factor of the expected activity volume and the fee or charge2.
2013-14 Estimated outcome $m |
2014-15 Forecast $m |
|
---|---|---|
Annual charges | 21.2 | 23.0 |
Application fees | 10.5 | 10.3 |
Evaluation fees | 28.7 | 29.9 |
Other3 | 2.1 | 1.8 |
Total | 62.5 | 65.0 |
Fees and charges are established to cover the cost of all direct, corporate and support costs for the sector. The costing methodology allows costs to be allocated to activities based on their resource consumption at each stage of the process through to the final product or services.
Total costs are categorised into the following groups for cost allocation and transparency purposes.
Cost allocation is undertaken in a three stage process.
In the first stage, the regulatory offices with significant contribution to the sector, as the source of direct costs, are identified. For the prescription medicines sector, these are the Office of Medicines Authorisation, Office of Scientific Evaluation, Office of Laboratory and Scientific Services and the Office of Product Review.
In the second stage, corporate costs are allocated to all offices, both regulatory and support, based on the driver that best reflects the use of the corporate service. For example, rent and other property operating costs are allocated using floor space and information technology costs are allocated by FTE.
In the third stage, support costs are assigned to regulatory offices based on a driver that is related to the services provided by the support team.
2013-14 Estimated outcome $m |
2014-15 Forecast $m |
|
---|---|---|
Direct costs | 24.5 | 25.4 |
Corporate costs | 5.3 | 5.4 |
Support costs | 16.1 | 15.5 |
Total | 45.9 | 46.3 |
2013-14 Estimated outcome $m |
2014-15 Forecast $m |
|
---|---|---|
Direct costs | 3.3 | 3.5 |
Corporate costs | 0.7 | 0.7 |
Support costs | 11.1 | 11.9 |
Total | 15.1 | 16.1 |
2013-14 Estimated outcome $m |
2014-15 Forecast $m |
|
---|---|---|
Expenses | 61.0 | 62.4 |
Revenue | 62.5 | 65.0 |
Balance | 1.5 | 2.6 |
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Cost recovery revenue will be reported in the Department of Health's Annual Report in accordance with the Finance Minister's Orders.
The TGA executive is provided with monthly financial reports showing progress against budget and an analysis of financial performance and position undertaken by the TGA Chief Financial Officer.
2011-12 $m |
2012-13 $m |
2013-14 Estimated outcome $m |
|
---|---|---|---|
Expenses | 55.9 | 59.4 | 61.0 |
Revenue | 58.6 | 64.0 | 62.5 |
Balance | 2.7 | 4.6 | 1.5 |
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The TGA reports to stakeholders at six monthly intervals on our progress in delivery against a set of agreed Key Performance Indicators (KPIs). The KPIs have been endorsed by the Australian Therapeutic Goods Advisory Council following consultation with the TGA-Industry Consultative Committee. For more information on the TGA's KPIs please visit: TGA key performance indicators: Our indicators and reporting measures.
The KPIs are high-level indicators for the TGA's overall performance against our broad strategic intent. Within that matrix of KPIs is a requirement for measuring whether 'business operations are consistent and meet agreed service and timeliness standards'. Measures of specific business activities will continue to be documented in our Half-yearly performance reports.
These reports are provided to members of the TGA-Industry Consultative Committee to enable us to report on specific parameters of relevance to industry stakeholders and to enable stakeholders to provide performance feedback. They provide detailed quantitative information about our performance on the timeliness of business activities as well as information for industry about the volumes of work performed by the TGA.
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During 2014-15 a review of fees and charges will be undertaken following development of a new activity based costing prepared in 2013-14. Consultation with industry representatives will be carried out to gather input on the framework of fees and charges and on proposed changes identified by the TGA, leading to revised fees and charges where appropriate.
Opportunities include alignment of over-the-counter (OTC) medicine fees to the new risk based categorisation of applications, and review of Good Manufacturing Practice (GMP) fees and charges. Annual charges, which primarily fund post-market regulatory activities such as the monitoring of product safety and of compliance with regulatory obligations, are subject to possible change with the review of the low value turnover (LVT) exemption scheme and the proposed introduction of clinical quality registers for implantable cardiac and breast devices.
The LVT scheme, introduced in 1990, allows sponsors to seek an exemption from payment of an annual charge where the annual turnover of the product is less than or equal to 15 times the annual charge for that product. The TGA has commenced a policy and operational review of the LVT scheme, the first stage of which was the release of the public consultation paper with submissions received in May 2014.
In 2014-15, the TGA will continue to identify opportunities for reducing regulatory burden on industry, consistent with the Government’s deregulation and red tape reduction agenda, while continuing to meet the objectives of safeguarding and enhancing the health of the Australian community. Changes to the regulatory framework arising from this work may have a flow on impact on fees and charges.
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I certify that this CRIS complies with the Australian Government Cost Recovery Guidelines.
Jane Halton
Secretary
Department of Health
Date: 26 June 2014
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Fees and charges for the prescription medicine sector for 2013-14 are outlined below.
Registration fees | 2013-14 Application Fee $ |
2013-14 Evaluation Fee $ |
---|---|---|
New Chemical Entity | 43,200 | 173,000 |
New Chemical Entity of a medicine used as an ancillary medical component of a device (item 4(aa)(i) and 4(aa)(ii)) | 14,400 | 57,700 |
New Chemical Entity of a medicine used as an ancillary medical component of a device (item 4(aa)(iii)) | 28,800 | 115,200 |
Extension of indications | 25,700 | 102,800 |
Extension of indicators of a medicine used as an ancillary medical component of a device - chemistry, quality control and manufacturing or pre-clinical studies | 8,570 | 34,300 |
Extension of indicators of a medicine used as an ancillary medical component of a device - documentation mentioned in subparagraphs (i) and (ii) | 17,200 | 68,500 |
Major variations | 16,800 | 66,900 |
Major variation of a medicine used as an ancillary medical component of a device - chemistry, quality control and manufacturing or pre-clinical studies | 5,590 | 22,200 |
Major variation of a medicine used as an ancillary medical component of a device - documentation mentioned in subparagraphs (i) and (ii) | 11,200 | 44,700 |
New generic product | 16,600 | 66,000 |
Additional trade name | 2,720 | 10,900 |
Minor variations (Change in formulation, composition, design specifications, type of container or change of trade name) | 990 | 3,940 |
Variation fees | 2013-14 Application Fee $ |
2013-14 Evaluation Fee $ |
---|---|---|
Variations to a Register entry involving the evaluation of clinical, pre-clinical or bio-equivalence data, but not included in another fee category. Includes applications for changes to Product Information involving the evaluation of clinical, pre-clinical or bio-equivalence data. | 990 | 3,940 |
Variations to a Register entry involving the evaluation of only chemistry, quality control or manufacturing data. Includes applications for changes to Product Information involving the evaluation of only chemistry, quality control or manufacturing information. |
4,930 | |
Variations to a Register entry (requiring changes to Product Information) with no evaluation of data 'minor editorial changes' | 1,520 | |
Testing and provision of advice, requested from Pharmaceutical Benefits Program, prior to listing on Pharmaceutical Benefits Listing Program (*this item is inclusive of GST) |
1,990 (2,189*) |
Administrative charges | 2013-14 Fee $ |
---|---|
Correction of a Register entry | 1,520 |
Annual charges | 2013-14 Charge $ |
---|---|
Biological Medicines (Biologics) | 6,430 |
Non-Biologics | 3,860 |
Clinical trials | 2013-14 Fee $ |
---|---|
CTX 30 Days | 1,560 |
CTX 50 Days | 19,400 |
CTN | 320 |
CTN - more than one trialing body | 320 |