TGA business plan 2018-19
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 Advisor and the Chief Medical Advisor. Medicines Regulation Division and Medical Devices and Product Quality Division apply risk-based approaches to evaluating, assessing and monitoring therapeutic goods. Regulatory Practice and Support Division supports international cooperation and convergence; stewards compliance and enforcement activity; provides regulatory education, guidance and assistance; and facilitates our cost recovery arrangements.
This Business Plan sets out our product regulation, regulatory reform, international engagement and regulatory compliance agenda for 2018-19 and the steps we will take to achieve our vision.
It 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 Strategy 2016-2020. Details are provided on how we will meet our key deliverables in relation to the regulation of therapeutic goods.
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 we will deliver in 2018-19.
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 burdens. 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 2018-19 we will continue to implement regulatory reforms, including those associated with the Government Response to the Expert Panel Review of Medicines and Medical Devices Regulation (the MMDR Review). In addition, we will implement a number of other major and necessary reforms to the regulatory system, as well as maintaining our core activities associated with providing high quality regulation of therapeutic goods in Australia.
The health landscape is complicated and dynamic. In response to this changing environment, we continue to innovate to improve our business processes, including through better use of the data provided by our stakeholders and improved data analytics.
Scientific advancements such as new cancer treatments and new technologies such as 3D bioprinting 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.
We continue to improve the regulatory system through our focus on implementing Government priorities and regulatory reforms. Implementation of the Government response to the MMDR Review began in 2016-17, with changes to our legislation and regulation enabling a significant number of reforms to be put into place in 2017-18. This year we will focus on implementing these reforms as well as other business and regulatory improvements. In doing this, we will ensure that stakeholders and consumers are informed about any changes to regulation and processes.
In 2018-19 we will increase our engagement with patients, consumers and health professionals by strengthening relationships with representative peak bodies. 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.
"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
Deputy Secretary, 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 and using innovative technologies and ideas to streamline business functions.
As a Commonwealth 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 that we regulate.
- We communicate meaningfully with stakeholders, 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 2018-19 our key priorities are identified under four main activity streams:
- Product regulation - through our core regulatory activity ('business as usual') and business process improvements.
- Regulatory reform - including activities associated with the continued implementation of recommendations from the Medicines and Medical Devices Regulation Review.
- International engagement - through activities associated with the promotion of international work sharing and regulatory convergence.
- Regulatory education and compliance - through monitoring, targeted compliance and enforcement activities and appropriate action.
Our priorities are derived from:
- our legislative framework
- the Long-Term National Health Plan, as articulated in the Health Portfolio Budget Statements
- the Department of Health Corporate Plan
- the Government Response to the Medicines and Medical Devices Regulation Review
- the Key Performance Indicators (KPIs) outlined in the Regulator Performance Framework
- emerging public health issues and emerging government policies that affect regulation
- proactively responding to innovations in therapeutic goods, which may require updates to regulation
- international work sharing and harmonisation.
In order to provide transparency to industry, healthcare professionals and the Australian public we publish a number of reports on the TGA website.
We respond to the performance commitments outlined in the Health Portfolio Budget Statements 2018-19 in the context of the Department of Health Annual Report. In addition, we demonstrate achievement against these priorities through reports and other information on our website.
We report in detail on our performance through the TGA Annual Performance Statistics Report which provides data for the July to June period each year. We also publish a Half Yearly Performance Snapshot with a subset of data covering July to December.
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 prepare a Self-Assessment Report that provides a qualitative measure of our performance against the Framework. This report involves our external validator (the TGA Industry Forum, comprised of ten peak industry associations) assessing our performance against the KPIs and assisting us with identifying opportunities for improvement of our practices and processes followed by reporting on performance to the Minister annually. We use this feedback to inform our future priorities.
In addition, we publish performance information through the following documents, which are available on our website:
- prescription medicines approvals reporting
- laboratory testing results
- monitoring, compliance and investigations outcomes
- post-market reviews
- annual stakeholder survey
- publications detailing how we are improving access to therapeutic goods for consumers and streamlining regulatory processes by implementing the Government Response to the MMDR Review.
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 currently around $163 million and we operate on a full 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.
Our Cost Recovery Implementation Statement (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.
The 2016-17 Budget measure, Improving the Regulation of Therapeutic Goods in Australia, permitted $20.4 million to be invested (from TGA reserves) to meet the costs of implementing the regulatory reforms arising from the MMDR Review. As a result of implementing these reforms a number of changes were required to existing fees and charges as well as the introduction of new fees.
We are responsible for assessing whether therapeutic goods available for supply in Australia are safe and fit for their intended purpose. Products for which therapeutic claims are made are assessed by the TGA and, if approved, are entered on the ARTG. These therapeutic goods can be lawfully supplied in Australia and include prescription medicines, over-the-counter medicines, complementary medicines, biologicals, and medical devices. We regulate the supply of:
- medicines prescribed by a doctor, dentist or other approved prescribing health care professional
- medicines available from behind the pharmacy counter
- medicines available in the general pharmacy
- medicines available from retail outlets
- complementary medicines, such as vitamins, herbal and traditional medicines
- medical devices, from simple devices like bandages to complex technologies like heart pacemakers
- in vitro diagnostic medical devices (IVDs) such as blood tests used to test for various diseases or conditions
- vaccines, blood products, and other biologicals.
We conduct pre-market assessment, post-market monitoring and enforcement of standards, licensing of Australian manufacturers and verifying overseas manufacturers' compliance to local and adopted international standards.
We continuously look for opportunities to reduce regulatory burden on stakeholders by strengthening our relationships and understanding their business without compromising the health and safety of Australians.
Outlined in the table below is the work we will be doing as part of our ongoing regulatory reform and business as usual activities.
There are a range of reforms forecast for delivery in 2018-19, including those developed in response to the MMDR Review. All reforms are aimed to support better health outcomes for Australians and to reduce regulatory burden.
Implementation of the Government Response to the MMDR Review will continue throughout 2018-19 and we will consolidate those reforms already implemented. 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.
Aside from the MMDR reforms we will also be implementing other reforms to ensure a greater emphasis on transparency of regulatory decision-making processes, improve efficiencies in our business processes and adopt a more strategic approach to the use of information technology to support regulatory operations.
Overviews of our 2018-19 MMDR and other major regulatory reform activities are provided in the tables below.
|Prescription medicine reforms||
|Complementary and over-the-counter medicine reforms||
|Medical device reforms||
|Post-market monitoring reforms||
|Access to unapproved therapeutic products reforms||
|Scheduling Policy Framework, advertising of pharmacist only medicine||
|Low risk therapeutic goods reforms||
|Advertising of therapeutic goods reforms||
|Complementary and over-the-counter medicine reforms||
|Medical device reforms||
|Post-market monitoring reforms||
|Good Clinical Practice Reforms||
Business as usual activities
|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 fully cost recovered framework||
Governance and support functions
|Monitor and enforce compliance of therapeutic goods||
As the challenges and priorities of therapeutic goods regulators have much in common, international engagement provides opportunities for discussing common challenges and learning from one another. In addition, closer alignment of international regulatory frameworks to provide opportunities for the increased use of assessments from comparable regulators in reaching regulatory decisions in Australia. Other benefits arise from the sharing of regulatory best practice, and when we are able to assist less advanced regulators to strengthen their capabilities.
An Annual International Operations Plan for 2018-19, published on our website, identifies projects and activities, as well as the benefits to be realised from those activities. This Plan is based on the International Engagement Strategy 2016-2020, which sets out three main goals for our international work. These goals are:
- contributing to public health and safety through regulation
- working with others to improve regulatory systems, including our own
- participating 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 OECD countries - through reduced workloads and less duplication.
We will continue to actively participate in fora that bring together regulators from across the world and provide the opportunities to collaborate and influence international regulatory policy. Closer to home, we are working with counterpart regulators in the Indo-Pacific region and Pacific Island countries in programs aimed at strengthening regulatory capacity and ensuring access to medicines of assured quality.
Details of our international activities are outlined in the table below.
|Improved public health and safety||
|Improved regulatory systems||
|Advanced work sharing, information sharing and regulatory convergence||
We are committed to protecting the health of the Australian public through intelligence-led, risk-based compliance and enforcement activity and are dedicated to working with industry and consumers to support voluntary compliance. Over the year we will be seeking to harmonise our compliance functions through better use of data collection and streamline compliance processes. We will also work towards greater transparency through the publication of compliance activity outcomes.
We update our Compliance and Enforcement Plan annually and also develop individual targeted Regulatory Compliance Plans to mitigate the compliance risks of areas that are identified as high risk. In line with ongoing monitoring of areas showing high risk of non-compliance we have developed a Cosmetic Industry Compliance Plan to target unapproved, unregistered and counterfeit therapeutic goods used in the cosmetic industry.
We will also include updates to the sanctions and penalties applicable to breaches of the Therapeutic Goods Act 1989 and supporting regulations.
This year, as we do every year, we will work to improve our relationships with key stakeholders within the Commonwealth and our state and territory counterparts. These relationships facilitate intelligence-led, risk-based activity and provide us with further opportunities to remove illegal and/or non-compliant therapeutic goods from the Australian market, thereby protecting the Australian public from goods that pose an unacceptable risk to health and safety.
Further compliance and enforcement activities are planned for 2018-19 as detailed in the table below.
|Protect the health of the Australian public through intelligence-led, risk-based compliance and enforcement activities||
|Collaboration across TGA on compliance target areas||