Therapeutic Goods Administration Business Plan …P. 4 | TGA Business Plan 2019-20 Introduction The...

Therapeutic Goods Administration

Business Plan 2019-20

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Contents Introduction __________________________________________ 4

Vision ________________________________________________ 5

Strategic framework __________________________________ 5

Environment _________________________________________ 6

Purpose ______________________________________________ 7

Principles _____________________________________________ 8

Priorities _____________________________________________ 8

Reporting ____________________________________________ 9

Funding _____________________________________________ 10

Product regulation __________________________________ 10

International engagement ___________________________ 18

P. 4 | TGA Business Plan 2019-20

Introduction 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.


Vision 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.

Strategic framework 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.


Environment 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.


Purpose “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, providing education and guidance, and using innovative technologies and ideas to streamline business functions.


Principles 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.

Priorities In 2019–20 our key priorities are implemented through four activity streams:

1. Product regulation and safety – through our core regulatory activity and business process improvements.

2. Regulatory reform – including activities associated with the continued implementation of recommendations from the Review of Medicines and Medical Devices Regulation.

3. 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.

4. Regulatory education and compliance – through education, monitoring, targeted compliance and enforcement activities and appropriate action.

Our priorities are derived from: · The Therapeutic Goods Act 1989 and related regulations · Health Portfolio Budget Statements · the Department of Health Corporate Plan · the TGA International Engagement Strategy 2016-2020 · the Key Performance Indicators (KPIs) outlined in the Regulator Performance

Framework · the Government Response to the Review of Medicines and Medical Devices Regulation

(MMDR)

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.


Reporting 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:

1. Regulators do not unnecessarily impede the efficient operation of regulated entities 2. Communication with regulated entities will be clear, targeted and effective 3. Actions undertaken by regulators are proportionate to the regulatory risk being managed 4. Compliance and monitoring approaches are streamlined and coordinated 5. Regulators are open and transparent in their dealings with regulated entities 6. 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.

Outcomes

Department of Health Annual Report

TGA Performance Reporting

TGA Business Plan

Health Portfolio Budget Statements

Plan

ning

Reporting


Funding 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.

Product regulation 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.

Regulatory reform

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:

Major regulatory reform activities for 2019-20

Outcome Activities

Prescription medicine · Enhance business processes and IT systems to support prescription medicines process, reforms and future electronic submissions

· Finalise and support the adoption of the revised Consumer Medicine Information template by industry

· Continue work-sharing product evaluations with Australia-Canada-Singapore-Switzerland consortium partners

· Support utilisation of appropriate comparable overseas regulator reports for registration of medicines and new indications

· Implementation of reforms to business and regulatory processes, relating to the evaluation of generic medicines

· Implement further improvements to business processes for minor variations to prescription medicines, including recognition of additional types of variations that can be ‘notified’ to the TGA

Complementary and over-the-counter medicine reforms

· Consult with stakeholders to develop and implement a mechanism to make it clear which products, including sports supplements, are considered therapeutic goods for the purposes of the Therapeutic Goods Act 1989

· Use of evaluation reports from comparable overseas regulators for evaluation of registered complementary medicines, assessed listed medicines and listed medicine ingredients

· Enhancements to the listed medicines post-market compliance scheme, including publication of review outcomes and increased use of data linkage and analytics

· Update guidance material for evidence requirements for listed medicines

· Update the Australian Regulatory Guidelines for Complementary Medicines

· Develop new approval pathways for sunscreen ingredients and excipients.



Outcome Activities

Biologicals reforms · Implement restrictions to the advertising and supply of autologous cell and tissue therapies that involve significant processing

· Implement policies and regulatory changes for the regulation of faecal microbial transplant products

Medical device reforms

· Propose an improved regulatory framework for the emerging technologies of software as a medical device, companion diagnostics, and the medical application of 3D printing

· Improve traceability of medical devices in the supply chain through development and adoption of a Unique Device Identification (UDI) system

· Continue to recognise opportunities to align medical device regulations with comparable overseas regulations

· Strengthen consumer awareness of how safety and performance of medical devices are assessed

· Consult on new proposals outlined in an Action Plan for Medical Devices that focus on enhancing patient safety and increase information available to patients

Good Clinical Practice reforms

· Implement a voluntary pilot program of Good Clinical Practice inspections of Australian Clinical Trials

Post-market monitoring reforms

· Enhance the post-market monitoring system for medical devices including early detection and action in relation to emerging issues

· Implement regulatory options supported by public consultation to address the issue of opioid abuse and misuse. This includes review of opioid indications, pack sizes, Consumer Medicines Information and label warnings in addition to working with external stakeholders to improve healthcare professional and patient education

· Update the Pharmaceutical Inspection Cooperation Scheme guidance to reflect current best practice (version PE009-14)

Scheduling reforms · Implement a framework for the use of Appendix M of the Poisons Standard to allow additional conditions on medicines that are down-scheduled from Prescription only to Pharmacist only medicines



Outcome Activities

Advertising reforms · Implement the Government’s decision to remove advertising pre-approvals

· Make the advertising of all therapeutic goods to the public consistent across product types

· Continue a comprehensive education program to underpin advertising reforms and aid advertiser compliance

Core regulatory activities Our product regulation activities for 2019-20 are outlined in the table below:

Product regulation activities for 2019-20

Outcome Activities

Pre-market evaluation, assessment and approval of medicines, medical devices, biologicals and other therapeutic goods supplied in Australia

Evaluation and assessment · Evaluate and process applications within legislated or

target timeframes for market authorisation of prescription, over-the-counter and complementary medicines, biologicals, blood components and medical devices (including IVDs) that are imported into, exported from, manufactured and/or supplied in Australia

· Embed new orphan criteria and expedited prescription medicines approval pathways as a core regulatory activity

· Regulate devices and medicines through their lifecycle (pre and post-market) by efficient and accountable regulatory practice

· Provide access to unapproved therapeutic goods for use in Australia where no alternative treatment is available through the Special Access Scheme (SAS) and the Authorised Prescriber scheme

· Process notifications and applications for SAS, Clinical Trials, Authorised Prescriber, and short term access to alternative medicines within specified timeframes



Outcome Activities

· Issue licenses and permits for medicinal cannabis to support domestic patient and international export requirements

· Update and maintain the Poisons Standard (Standard for the Uniform Scheduling of Medicines and Poisons)

· Continue review of Chemical Scheduling in relation to cosmetics and fragrance ingredients.

Risk management · Monitor Risk Management Plans required by

sponsors for high risk medicines to ensure they are undertaking the monitoring and risk mitigation activities identified in the plan

· Continue to publish sponsor notifications of critical medicines shortages and monitor sponsor compliance with medicine shortage notification obligations

Transparency · Continue publication on our website of prescription

medicine transparency documents such as Australian Public Assessment Reports (AusPARs) and announcements of the registration of new prescription medicines in Australia

Ongoing monitoring of the safety, efficacy, performance and quality of medicines, medical devices, biologicals and other therapeutic goods

Safety · Investigate and monitor safety issues in a timely

manner, using a risk-based framework · Continue enforcement activity jointly with other

Commonwealth, state and territory agencies, targeting registered and unregistered therapeutic goods non-compliance

· Undertake risk-based inspections of sponsors’ pharmacovigilance systems to assess compliance with requirements

· Utilise and further explore large health datasets such as the Medicare Benefits Schedule and the Pharmaceutical Benefits Scheme in detection of potential safety issues

· Remove from the market products that pose an unacceptable risk to consumers

· Continue to monitor and review the appropriate use of strong opioids



Outcome Activities

· Continue to update the Therapeutic Goods (Permissible Ingredients) Determination to reflect evaluation undertaken on the safety and quality of ingredients available for use in listed medicines

· Continue to maintain the Poisons Standard, the national regulatory framework for the access of substances, and provide advice to key stakeholders within the department, across industry, government and consumer sectors

Manufacturing quality · Regulate manufacturers of therapeutic goods

through risk-based inspection and desk-top assessment programs to confirm the quality of therapeutic goods supplied in Australia from domestic and international manufacturers meet specified standards and principles

· Undertake risk-based testing to monitor medicines, medical devices and biologicals supplied in Australia for compliance with required standards and essential principles respectively

· Six monthly publication of laboratory compliance testing results on the TGA website

Education and compliance · Monitor compliance, including the quality, supply

and advertising of therapeutic goods, and enforce compliance utilising new sanction and penalty tools where necessary

· Continue education and awareness raising activities to support adverse event reporting by consumers and health professionals

· Educate consumers about counterfeit therapeutic goods through publishing safety alerts and other education material

· Continue to provide guidance and education to small-to-medium enterprises, start-ups, researchers and new industry stakeholders through SME Assist

· Manage our digital submission and monitoring systems for prescription and over-the-counter medicines

· Monitor and review the new designation process and eligibility criteria for orphan drugs



Outcome Activities

· Publish compliance review outcomes and ratings for listed medicines and educate consumers about the compliance review ratings scheme

· Support stakeholders in completing the transition to updated labelling and harmonised ingredient name requirements

Business activities to support regulatory outcomes and a cost recovered framework

Governance and support functions · Ensure that fees and charges appropriately reflect

the regulatory effort involved and our cost recovery obligations

· Implement agreed recommendations of the Australian National Audit Office’s Application of Cost Recovery Principles Audit

· Continue to support and maintain governance arrangements for our statutory advisory committees, manage specialist expert advisory groups, and source specialist advice when necessary to strengthen our regulatory decision making processes

· Provide timely, accurate and appropriate information to support parliamentary, media, Freedom of Information, reporting and secretariat services

· Continue to assess the performance of legislative instruments that are scheduled to sunset to ensure that instruments are achieving their objectives

· Ongoing stakeholder engagement through stakeholder surveys, public consultations, market research, and formal and informal forums

· More streamlined management of general email and phone enquiries from external stakeholders.

Regulatory guidance · Continue to produce new and updated regulatory

guidance that is accessible and user friendly.



Outcome Activities

Education · Deliver and share regulatory education materials,

including video and animations, eLearning, articles, webinars and fact sheets, that improve understanding of regulatory processes and requirements for consumers, health professionals and industry

· Support small to medium enterprises, start-ups, researchers and those unfamiliar with therapeutic goods regulation to better understand regulatory requirements

· Improve the TGA website, ensuring it is accessible, easy to navigate, accurate, and enables engagement with stakeholders including industry and the general public

· Build our education capability and offerings by partnering with strategic groups to enhance our engagement with consumer, health professional and industry stakeholders on a broad range of issues impacting the regulation of therapeutic goods and consumer health outcomes

· Manage the TGA’s social media and blog content including Facebook, Twitter, YouTube and Slideshare

Monitor and enforce compliance of therapeutic goods

· Reduce low level non-compliance through education and guidance using proactive communication strategies

· Monitor the market for signals of potential non-compliance, through complaints, referrals and intelligence activities, and carry out investigations against a risk based compliance framework, utilising appropriate education and enforcement approaches to address and deter non-compliance

· Develop compliance plans to address compliance priorities identified during the year through monitoring, data analysis and intelligence activities

· Continue to collaborate with state, territory, federal and international partners on matters of compliance and intelligence


International engagement

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.


International engagement activities for 2019-20

Outcome Activities

Improved public health and safety

· Continue to work closely with countries and coordinate activities with partners in the region for the purpose of delivering the Indo-Pacific Regulatory Strengthening Program and Pacific Medicines Testing Program in partnership with the Department of Foreign Affairs and Trade

· Participate in international regulator forums when considering vaccines, medical devices, complementary or prescription medicines or the implementation of pharmacovigilance activities to ensure emerging regulatory policy is aligned with international best practice

· Support bilateral and multilateral agreements that underpin our international engagement

Improved regulatory systems

· Establish new relationships specifically with countries in our region, and working with comparable overseas regulators to increase efficiencies in regulatory systems and processes. For example, to accelerate regulatory alignment, faster approval processes for certain medicines and medical devices, and explore how risk assessments and determinations by comparable regulators can be used more extensively

· Enhance pharmacovigilance activities and engagement with overseas counterparts to identify sources of supply to alleviate medicine shortages; undertake quality system audits of manufacturing facilities; strengthen intelligence with respect to provisionally approved medicines; and facilitating the exchange of information about medical device adverse events

Advanced work sharing, information sharing and regulatory convergence

· Participate in programs to develop enhanced collaboration frameworks with comparable overseas counterparts and promote the use of aligned regulatory systems and processes to reduce unnecessary duplication of effort across regulators

· Support the development of standards that ensure the safety and quality of products by working with standard setting bodies, including the International Organization for Standardization and Standards Australia

Further information about our work with international agencies and overseas regulators is available on the International page <https://www.tga.gov.au/international> on the TGA website.

Therapeutic Goods Administration

PO Box 100 Woden ACT 2606 Australia

Email: [email protected] Phone: 1800 020 653 Fax: 02 6203 1605

https://www.tga.gov.au

mailto:[email protected]

https://www.tga.gov.au/

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