Source: Australian Department of Health
The Therapeutic Goods Administration (TGA) is part of the Health Products Regulation Group (HPRG) within the Department of Health and is committed to delivering a world class, efficient and timely regulatory system for therapeutic goods.
HPRG comprises three divisions, which are supported by the Regulatory Legal Services Branch, the Principal Legal and Policy Adviser and the Chief Medical Adviser. Medicines Regulation Division and Medical Devices and Product Quality Division apply risk-based approaches to evaluating, assessing and monitoring therapeutic goods. The Regulatory Practice and Support Division supports international cooperation and convergence; carries out compliance and enforcement activities; provides regulatory education, guidance and assistance; and facilitates our cost recovery arrangements.
The Business Plan sets out our product regulation, regulatory reform, international engagement and regulatory compliance agenda for 2019-20 and the steps we will take to achieve our vision. It also supplements the Health Portfolio Budget Statements and the Department of Health Corporate Plan and is supported by the Australian Government’s Regulator Performance Framework and the TGA International Engagement Strategy 2016-2020.
The TGA Business Plan is updated annually and is a central part of our activity planning and performance monitoring framework.
Within this Business Plan we have provided an overview of our key commitments and a list of outcomes planned for delivery in 2019-20.
Our vision is:
Better health and wellbeing for all Australians through regulatory excellence
This links directly with the Department of Health vision:
Better health and wellbeing for all Australians now and for future generations
We protect the health and safety of the community by regulating therapeutic goods. We strive for regulatory excellence through our:
- purpose – who we are and what we do
- principles – how we will conduct ourselves
- priorities – what we will focus on
- people – focussing on our staff development and wellbeing
- stakeholders- through transparency, meaningful engagement and education.
By regulating therapeutic goods in accordance with the Therapeutic Goods Act 1989 and supporting regulations, we contribute to the department’s strategic priorities:
- Better health and ageing outcomes and reduced inequality
- Affordable, accessible, efficient, and high quality health and aged care system.
Our commitment to achieving the department’s strategic priorities is articulated through:
- Regulation that protects the health and safety of the community, while minimising unnecessary compliance burden. We protect the health and safety of the Australian community through effective, timely and risk proportionate regulation of therapeutic goods (including medicines, medical devices, blood, cell and tissue products). This applies to goods exported, imported, supplied and manufactured in Australia.
In 2019-20 we will continue to implement regulatory reforms, with a focus on emerging medical technologies, and increase international regulatory cooperation, particularly on the review of new medicines, and medicines and medical device safety. We will also maintain our core activities associated with providing high quality regulation of therapeutic goods in Australia, as well as continue to provide education and guidance to the Australian public as well as to industry and health professionals.
The health landscape is complex and dynamic. In response to this changing environment, we continue to innovate to improve our business processes through the better use of the data provided by our stakeholders and improved data analytics.
Scientific advancements such as new cancer treatments and personalised medicine, and new technologies including custom device manufacture (3D printing), continue to bring opportunities for Australians. They also require a regulatory framework that is contemporary, adaptable and supports innovation. Our challenge is to capitalise on advancements in technology while ensuring that regulation is appropriate to manage risk.
In 2019-20 we will continue to increase our engagement with patients, consumers and health professionals by strengthening relationships with representative peak bodies. To assist consumers in making informed choices, we will continue to identify opportunities to make information about therapeutic goods publically available, where appropriate. To remain competitive globally and to reduce duplication in the regulatory review of products, we will also continue to collaborate with our international regulatory counterparts on information and work sharing activities and assess opportunities to align regulatory requirements that support global access to safe, effective therapeutic goods.
“Our role is to enable access to safe and effective medicines, medical devices, a safer blood supply and cell and tissue therapies that benefit as many people in the community as possible. No product is without risk and uncertainty and the role of the TGA is to assess and balance these factors along with benefits in our decision-making.”
Adjunct Professor John Skerritt
Health Products Regulation Group
The TGA is responsible for protecting the health and safety of the community by regulating therapeutic goods for safety, efficacy, performance and quality. Consistent with the Therapeutic Goods Act 1989 we:
- apply scientific and clinical expertise to assess whether the benefits of a therapeutic good outweigh any risks to health and safety
- assess the suitability of therapeutic goods for supply, import and export from Australia
- regulate manufacturers of therapeutic goods to ensure they meet acceptable standards of manufacturing quality
- assess the quality and compliance of therapeutic goods on the market, including through laboratory testing where appropriate
- implement a range of regulatory actions (in response to non-compliance or emerging safety concerns) that are proportionate to the potential risk arising from the non-compliance or safety risk.
We achieve this by applying risk-based processes for both pre-market assessment and post-market monitoring, as well as promoting regulatory compliance through clear and transparent decision making, providing education and guidance, and using innovative technologies and ideas to streamline business functions.
As an Australian Government regulator we adhere to following principles:
- we are committed to maintaining the trust and confidence of the Australian public
- we are accountable to the government of the day and the Australian public and work cooperatively with the industry we regulate
- we communicate meaningfully with stakeholders including consumers, providing transparency across our regulatory practice
- we assess evidence in making decisions and recognise the value of taking a risk-based approach to regulatory, compliance and enforcement activity
- we perform our functions consistently to ensure predictable outcomes in like decisions.
In 2019-20 our key priorities are implemented through four activity streams:
- Product regulation and safety – through our core regulatory activity and business process improvements.
- Regulatory reform – including activities associated with the continued implementation of recommendations from the Review of Medicines and Medical Devices Regulation.
- International engagement – through activities associated with the promotion of international work sharing and regulatory convergence, as well as programs for regulatory strengthening and provision of medicines testing services in our region.
- Regulatory education and compliance – through education, monitoring, targeted compliance and enforcement activities and appropriate action.
Our priorities are derived from:
In addition, we will respond proactively to:
- emerging public health issues and emerging government policies that affect regulation
- proactively responding to innovations in therapeutic goods, which may require updates to regulation
- all identifiable opportunities for international work sharing and harmonisation.
We will also implement the Action Plan for Medical Devices.
In order to provide transparency to the Australian public, industry and healthcare professionals, we publish a number of statistical and performance reports and other information on both the TGA and Australian Government Department of Health websites.
We respond to the performance commitments outlined in the Health Portfolio Budget Statements, and report against the performance indicators in the Department of Health Annual Report. We report in detail on our performance through the TGA Annual Performance Statistics Report which provides data for each financial year (1 July to 30 June). We also publish a Half Yearly Performance Snapshot with a subset of data covering 1 July to 31 December each year.
We provide transparency and are held accountable to our stakeholders by reporting against the six KPIs under the Regulator Performance Framework. These outcomes-based KPIs articulate the overarching expectations of regulators’ performance:
- Regulators do not unnecessarily impede the efficient operation of regulated entities
- Communication with regulated entities will be clear, targeted and effective
- Actions undertaken by regulators are proportionate to the regulatory risk being managed
- Compliance and monitoring approaches are streamlined and coordinated
- Regulators are open and transparent in their dealings with regulated entities
- Regulators actively contribute to the continuous improvement of regulatory frameworks.
We publish an annual Self-Assessment Report that provides measures of our performance against the Framework. The report is externally validated by the TGA Industry Forum, which comprises of ten peak industry associations. The Forum assesses our performance and self-future process improvements.
In addition, we publish the following performance information on the TGA website:
- laboratory testing results
- monitoring, compliance and investigations outcomes
- post-market reviews
- publications detailing how we are improving access to therapeutic goods for consumers.
The relationship between our planning and reporting activities is illustrated below. This framework allows us to set out what we plan to do at the beginning of the financial year and then report on what we have achieved by the end of the period.
The TGA annual budget is approximately $165 million and we operate predominantly on a cost recovery basis. The regulatory costs are recovered through fees and charges levied on sponsors and manufacturers of therapeutic goods. We use an activity based costing model to calculate the relevant costs for each activity we undertake.
Annual Cost Recovery Implementation Statements (CRIS) provides information on how we implement cost recovery activities associated with the registration and listing of medicines and inclusion of medical devices, including in vitro diagnostic devices (IVDs), and biologicals on the Australian Register of Therapeutic Goods (ARTG) and their ongoing monitoring and surveillance. The CRIS (available on our website) is prepared and updated at least annually as required under the Australian Government Cost Recovery Guidelines.
We assess therapeutic goods available for supply in Australia to ensure they are safe and fit for their intended purpose. Approved therapeutic goods can be lawfully manufactured and supplied in Australia and include prescription medicines, over-the-counter medicines, complementary medicines, biologicals, and medical devices.
Products for which therapeutic claims are made are entered on the ARTG.
Some examples of goods that the TGA regulates the supply of include:
- medicines prescribed by a doctor, dentist or other approved prescribing health care professional
- medicines available from supermarkets, the general pharmacy or from behind the pharmacy counter
- complementary medicines, including vitamins, herbal and traditional medicines
- medical devices, from simple devices like bandages to complex technologies like heart pacemakers
- In Vitro Diagnostic tests used to test for various diseases or conditions, such as blood tests
- vaccines, blood and blood components, and biologicals (cells and tissues).
We conduct pre-market assessment, post-market monitoring and enforcement of standards as appropriate, licensing of Australian manufacturers, and verifying overseas manufacturers’ compliance to local and adopted international standards.
There are a range of reforms forecast for delivery in 2019-20. All reforms are aimed to support better health outcomes for Australians and we are mindful of the need to reduce regulatory burden where possible.
Implementation of the Government Response to the MMDR Review has largely been completed, with the exception of certain medical devices and complementary medicines reform. The MMDR Review assessed the regulatory framework for medicines and medical devices in Australia and made a number of recommendations to improve the availability of high quality, safe and efficacious products in a timely way to the community.
We are also committed to an ongoing program of business improvement focussed on transparency of regulatory decision-making processes, increased efficiencies in our business processes and a more strategic approach to the use of information technology to support regulatory operations.
Overviews of our 2019-20 major regulatory reform activities are provided in the following table:
|Complementary and over-the-counter medicine reforms||
|Medical device reforms||
|Good Clinical Practice reforms||
|Post-market monitoring reforms||
Core regulatory activities
Our product regulation activities for 2019-20 are outlined in the table below:
|Pre-market evaluation, assessment and approval of medicines, medical devices, biologicals and other therapeutic goods supplied in Australia||
Evaluation and assessment
|Ongoing monitoring of the safety, efficacy, performance and quality of medicines, medical devices, biologicals and other therapeutic goods||
Education and compliance
|Business activities to support regulatory outcomes and a cost recovered framework||
Governance and support functions
|Monitor and enforce compliance of therapeutic goods||
Across the globe regulators of medicines, medical devices and other therapeutic goods face similar challenges. International engagement provides opportunities for discussing common challenges and learning from one another. Closer alignment of international regulatory frameworks provides opportunities for the increased use of assessments from comparable regulators to allow us to make regulatory decisions in a timely manner. Other benefits arise from the sharing of regulatory best practice, including when we are able to assist less advanced regulators to strengthen their capabilities.
The International Engagement Strategy 2016-2020 sets out three main goals for our international work:
- contribute to public health and safety through regulation
- work with others to improve regulatory systems, including our own
- participate in work sharing and convergence activities.
The beneficiaries of our international regulatory collaboration activities are:
- patients – through earlier access to medicines and medical devices
- regional public health – by working towards disease elimination
- industry – through faster market access and lower costs
- regulators in our region – through the sharing of best practice and expertise
- regulators in Organisation for Economic Co-operation and Development (OECD) countries – through reduced workloads and less duplication.
We will continue to actively participate in fora that brings together regulators from across the world and provides opportunities to collaborate and influence international regulatory policy.
Australia also plays a significant role in the region in supporting regulatory counterparts to strengthen their regulatory practices and provide testing services with the goal of working towards access to better quality medicines within the Indo-Pacific and Pacific Island Countries. These activities are achieved through two aid programs.
Indo-Pacific Regulatory Strengthening Program
The Department of Foreign Affairs and Trade (DFAT), through the Health Security Initiative, has partnered with the TGA to establish and fund the Indo-Pacific Regulatory Strengthening Program (RSP). The TGA is leading the technical engagement for the RSP and working closely with Cambodia, Indonesia, Lao PDR, Myanmar, Thailand, Papua New Guinea and Vietnam to strengthen their regulatory practices and increase regional collaboration with the aim of increasing availability to quality therapeutic goods.
Pacific Island Countries Medicines Testing Program
The Australian Government through the TGA and DFAT are piloting a program to provide Pacific Island Countries access to Australian laboratory testing for medicines quality assurance. The program is focusing on testing medicines for non-communicable diseases (such as medicines for heart disease and diabetes), as well as antibiotics. Pacific Island Countries will be able to send medicines to TGA when there is a problem or a complaint. The testing is fully funded by DFAT. There are 11 countries participating: Federated States of Micronesia, Fiji, Kiribati, Nauru, Palau, Papua New Guinea, Samoa, Solomon Islands, Tonga, Tuvalu and Vanuatu. Details of our international activities are outlined in the following table.
|Improved public health and safety||
|Improved regulatory systems||
|Advanced work sharing, information sharing and regulatory convergence||
Further information about our work with international agencies and overseas regulators is available on the International page on the TGA website.