therapeutic goods administration business plan 2017-18 · | tga business plan 2017-18....

Therapeutic Goods Administration Business Plan

2017–18

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Copyright© Commonwealth of Australia 2017

This work is copyright. You may 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 by 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 <[email protected]>.

P. iii | TGA Business Plan 2017-18

Contents

Introduction .......................................................................................................1

Vision ................................................................................................................... 1

Strategic framework .........................................................................................2

Environment .......................................................................................................3

Purpose ............................................................................................................... 4

Principles ........................................................................................................... 5

Priorities .............................................................................................................. 5

Reporting ............................................................................................................ 6

Cost model .........................................................................................................7

Product regulation ...........................................................................................8

Regulatory Reform .........................................................................................12New regulatory pathway for medicines and medical devices ................12Variations to registered medicines ....................................................................12Access to unapproved therapeutic goods .....................................................13Further work .............................................................................................................13

International engagement ...........................................................................17

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P. 1 | TGA Business Plan 2017-18

IntroductionThe Therapeutic Goods Administration (TGA) is part of the Health Products Regulation Group within the Department of Health. This Business Plan sets out our product regulation, regulatory reform and international engagement agenda for 2017–18 and the steps we will undertake to achieve our vision.

This document supplements the 2017–18 Health Portfolio Budget Statements and the Department of Health Corporate Plan 2017–18 and is supported by the Government’s Regulator Performance Framework, the TGA Key Performance Indicators (KPIs), and the TGA International Strategy 2016–2020. Details are provided on how we will meet the Government’s and the Australian public’s expectations 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.

VisionOur 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 by focussing on our:

• Purpose – who we are and what we do• Principles – how we will conduct ourselves• Priorities – what we will focus on.

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Strategic frameworkBy regulating therapeutic goods in accordance with the Therapeutic Goods Act 1989 and supporting regulations we contribute to the department’s strategic priorities of:

• 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 as follows:

• Contributing to Australia’s health system through best practice regulation of health products. We safeguard and enhance the health of all Australians through effective, timely and risk proportionate regulation of therapeutic goods (including medicines, medical devices, blood, cell and tissue products), controlled drugs and drug substances. This applies to goods exported, imported, supplied and manufactured in Australia.

In 2017–18 we will continue to implement the regulatory reforms associated with the Government Response to the Expert Panel’s Review of Medicines and Medical Devices Regulation, and maintain our core activities associated with providing high quality regulation of therapeutic goods in Australia.


EnvironmentChange, especially in health products technology, is occurring at an unprecedented rate. Regulators of therapeutic goods need to be aware of innovation. For example, during 2017–18 it is anticipated that new regulatory frameworks for provisional approval of medicines, regulation of 3D printed devices and autologous cells will be developed to support innovation while maintaining safety standards. Many of the issues we face are also being addressed by our international counterparts.

We need to ensure that we can continue to innovate and contribute to the regulation of therapeutic goods both in Australia and overseas. Consultation with our stakeholders helps us to identify opportunities for continuous improvement in our regulatory practice.

We work collaboratively with our stakeholders including:• consumers• health professionals• industry• technical and scientific specialists• international regulatory counterparts.

In 2017–18 we will implement SME Assist, a new service to support small and medium sized enterprises and help them navigate their way through regulatory requirements.

We provide transparency and are held accountable to our stakeholders by reporting against the KPIs under the Government’s Regulator Performance Framework.

The Framework consists of six outcomes-based KPIs which 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 apply the Framework and continually endeavour to undertake our role with the minimum impact to achieve regulatory objectives and to effect positive, ongoing and lasting change.

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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, effectiveness/performance and quality. We do this in line with the Therapeutic Goods Act 1989 by:

• applying scientific and clinical expertise to ensure that the benefits of a therapeutic good outweigh any risks

• assessing the suitability of therapeutic goods for supply, import and export from Australia

• regulating manufacturers of therapeutic goods to ensure they meet acceptable standards of manufacturing quality

• assessing the quality and compliance of therapeutic goods on the market including through laboratory testing where appropriate

• implementing a range of regulatory actions (in response to non-compliance or unexpected 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 and compliance strategies• promoting regulatory compliance through clear and transparent

decision making and the provision of regulatory guidance• articulating underlying reasons for regulatory decisions and

providing them in a timely manner • using innovative technologies and ideas to streamline business

functions and promote effective and timely communication• supporting innovative technologies by providing clarity on

regulatory requirements• collaborating and sharing best practice regulatory outcomes with

international regulators.


Principles As a Commonwealth regulator we adhere to following principles:

1. We are committed to maintaining the trust and confidence of the Australian public.

2. We are accountable to the government of the day, the Australian public and the industry we regulate.

3. We communicate meaningfully with stakeholders, providing transparency across our regulatory practice.

4. We recognise the value of taking a risk based approach to regulatory action and decision making, compliance and enforcement activity.

5. We perform our functions consistently to ensure predictable outcomes in like decisions.

PrioritiesIn 2017–18 our key priorities are identified under three main activity streams:

1. Product Regulation – core regulatory activity (business as usual) and business process improvement.

2. Regulatory Reform – activity associated with the Expert Panel Review of Medicines and Medical Devices Regulation (the Review), as well as in several other areas.

3. International Engagement – activity associated with international work sharing and regulatory convergence.

Our priorities are derived from:• Our legislative framework• The Health Portfolio Budget Statements 2017–18• The Department of Health Corporate Plan 2017–18• The Government Response to the Review • The KPIs outlined in the Regulator Performance Framework.

As outlined in the Health Portfolio Budget Statements 2017–18 we contribute to achieving Outcome 5 – Regulation, safety and protection through protection of the health and safety of the Australian community and preparedness to respond to national health emergencies and risks, including through regulation of therapeutic goods.

Within this Business Plan we have provided an overview of our key commitments and a list of outcomes we will deliver in 2017–18.

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ReportingWe will respond to the performance commitments outlined in the Health Portfolio Budget Statements 2017–18 in the context of the Department of Health Annual Report 2017–18. In addition, we demonstrate achievement of our priorities through our reports and 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 prepare a Self-Assessment (KPI) Report providing a qualitative measure of our performance against the Regulator Performance Framework. This report involves our external validator (the TGA Industry Forum, comprised of ten peak industry associations) assessing our performance against the six KPIs and assisting us with identifying opportunities for improvement of our practices and processes. 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 for industry by implementing the Government Response to the Review.


Cost modelThe TGA annual revenue is currently around $150 million and is overwhelmingly derived from fees and charges recovered from industry. We use an activity based costing model to calculate the relevant costs for each activity we undertake.

Cost Recovery Implementation Statements (CRIS) provide 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 onto the Australian Register of Therapeutic Goods (ARTG) and their ongoing monitoring and surveillance. The CRIS (available on our website) will be prepared or updated for significant cost recovery arrangements when:

• reviews consistent with the Government’s review schedule for existing cost recovery arrangements are undertaken

• new cost recovery arrangements are proposed• material amendments are made to existing arrangements • periodic reviews of cost recovery arrangements are undertaken.

The 2016-17 Budget measure, Improving the Regulation of Therapeutic Goods in Australia, has permitted $20.4 million to be invested (to be met from TGA reserves) to meet the costs of implementation of regulatory reforms arising from the Review. Any change in ongoing costs as a result of the Review will be met via cost recovery arrangements through new, and changes to existing, fees and charges.

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Product regulationWe are committed to delivering a world class, efficient and timely regulatory system for therapeutic goods. Our two divisions, Medicines Regulation Division and Medical Devices and Product Quality Division, apply risk-based approaches to regulating therapeutic goods. In addition the Regulatory Practice and Support Division underpins work across the Group. We continuously look for opportunities to reduce regulatory burden on industry and health professionals without compromising the health and safety of Australians.

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 entered on the ARTG. These therapeutic goods can be lawfully manufactured and 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 or dentist • 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 • products used to test for various diseases or conditions (IVDs)

such as blood tests • vaccines, blood products, and other biologics.

We regulate therapeutic goods by:• evaluating applications to approve new medicines and medical

devices for supply in Australia within legislated or target timeframes

• monitoring medicines and medical devices approved for supply in Australia using a risk based approach

• ensuring Australian and international therapeutic goods manufacturers meet specified standards

• providing operational regulatory policy advice and support services to ensure efficient, best practice regulatory operations

• updating and maintaining the Standard for the Uniform Scheduling of Medicines and Poisons.


We achieve our regulatory outcomes by implementing appropriate policies to ensure best practice approaches to the assessment of applications and consistent decisions. We support our regulatory outcomes by continuously improving our business processes.

We conduct pre-market assessment, post-market monitoring and enforcement of standards, licensing of Australian manufacturers and verifying overseas manufacturers’ compliance with the same standards as their Australian counterparts. We will undertake a range of specific activities in 2017–18 as outlined in the table below.

Product regulation activities for 2017–18

Outcome Activities

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

Evaluation• Evaluate 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

• 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 and improve the Clinical Trial Notification system

• Consider potential antimicrobial resistance strategies during assessment of antimicrobials

• Develop and implement new regulatory requirements to help ensure the safety of autologous human cell and tissue products

• Implement changes to facilitate access to medicinal cannabis in Australia

Risk Management• Review, in collaboration with industry and health care professionals,

the system for reporting and management of medicine shortages• Ongoing lot release assessments of vaccines, including the seasonal

influenza vaccine • Assess Risk Management Plans within specified timeframes and

educate sponsors in risk minimisation methodology

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Outcome Activities

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

Safety• Investigate safety issues in a timely manner, using a risk-based

framework• Update the Therapeutic Goods (Permissible Ingredients)

Determination on a quarterly basis to reflect evaluation undertaken on the safety and quality of ingredients available for use in listed medicines

• Monitor safety signals associated with the use of therapeutic goods and undertake safety investigations and actions

• Ensure products that pose an unacceptable risk to consumers are removed from the market

• Develop streamlined post-market monitoring processes for complaints and improve the timeliness of compliance reviews

Manufacturing Quality• Regulate manufacturers of therapeutic goods through a risk based

audit and inspection program to ensure the quality of therapeutic goods supplied in Australia from domestic and international manufacturers meet specified standards and principles

• Ongoing risk based testing to monitor medicines and medical devices supplied in Australia for compliance with required standards

• Ongoing six monthly publication of laboratory compliance testing results on the TGA website to increase understanding of the TGA and its procedures

• Continue to regulate manufacturing quality and monitor and enforce Good Manufacturing Practice (GMP) compliance

Education and compliance• Monitor compliance, including the quality, supply and advertising of

therapeutic goods and enforce compliance where required • Continue education and awareness raising activities to support

adverse event reporting by consumers and health professionals• Manage our digital submission and monitoring systems for

prescription and over-the-counter medicines• Monitor and review the new designation process and criteria for

orphan medicines



Outcome Activities

Business activities to support regulatory outcomes and a fully cost recovered framework

Governance and regulation• 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

• Review existing legislation as ‘sunset’ dates approach, remaking legislative instruments such as Therapeutic Goods Orders where required

• 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

• Provide timely, accurate and appropriate information to support parliamentary, Freedom of Information and reporting services

Regulatory guidance• Continue to produce new and updated guidance that is user-

focussed, useful, readable, scannable, findable and accessible• Continue to provide targeted support activities for Small to

Medium Enterprises to help them better understand the regulatory framework

• Implement an enquiry management solution to support and streamline the tracking of general enquiries

Education• Deliver regulatory education materials that improve understanding

of regulatory processes and requirements for consumers, health professionals and industry

• Manage a website that is accessible, easy to navigate, accurate, and enables engagement with stakeholders including industry and the general public

• Manage the TGA’s social media presence through Twitter, YouTube and Slideshare

Monitor and enforce compliance of therapeutic goods

• Reduce low compliance risk through education and guidance undertaken by proactive communication strategies consistent with the regulatory compliance framework

• Monitor the market for signals of potential non-compliance across the range of regulatory areas covered by the Therapeutic Goods Act 1989 and employ a uniform risk-based approach to determining the significance of signals detected and the appropriate regulatory response

• Address high risk compliance through correcting behaviour by deterrence and detection and through cooperation with state, territory, federal and international partners

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Regulatory ReformIn 2016–17 we began implementing the Australian Government Response to the Review of Medicines and Medical Devices Regulation. The 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. In addition we have implemented reforms in other areas such as orphan medicines and autologous cells.

Implementation of the Government Response to the Review will continue throughout 2017–18 building upon the reforms already implemented, such as further amendments to the Therapeutic Goods Act 1989 and supporting regulations, which came into effect on 1 July 2017. Key reforms from these amendments include:

New regulatory pathway for medicines and medical devices A new priority review pathway for prescription medicines was implemented on 1 July 2017 and first applications are being assessed during 2017–18. The priority review pathway provides consumers and health professionals with up to three months faster access to eligible medicines and sponsors with a predictable and transparent pathway. The flexible priority review business process has a target timeframe of 150 working days. Implementation of a new provisional approval pathway for prescription medicines is subject to legislative changes introduced into Parliament in September 2017.

Medical devices reforms include changes to enable implementation of a priority assessment pathway for medical bodies from 1 January 2018 and the potential for Australian bodies to be designated by the TGA to undertake conformity assessment of medical devices.

Variations to registered medicinesA notification process for low risk variations to registered medicines, where these changes do not affect safety, quality or efficacy, is being implemented. Under this process, the sponsor notifies the TGA of the variation and the request is electronically validated allowing a computer program to inform the sponsor that the variation can be implemented.

The notification process for over-the-counter and registered complementary medicines, and the first step in the implementation for prescription medicines – a new e-form – were launched in July 2017. Notifications for prescription medicines will be in place before the end of 2017.


Access to unapproved therapeutic goodsA new ‘Category C’ notification became available under the SAS from July 2017 for certain unapproved therapeutic goods. These therapeutic goods are for patients that are not terminally ill and are available based on health practitioner notifications rather than requiring an application to be made under the Category B SAS scheme. More products will be considered for Category C over time, based on evidence of safe use.

A new online management system for SAS and the Authorised Prescriber scheme is also under development, and practitioners will be encouraged to submit forms online. The Authorised Prescriber process has been simplified and from 1 July 2017 is based on approval by an ethics committee or specialist college.

Further workWork during 2017–18 will focus on further reforms (many are subject to passage of legislation) to:

• establish a provisional approval pathway that will provide earlier access to certain promising new medicines that do not yet have a full dossier of data (in particular clinical data), where there is the potential for a substantial benefit to Australian consumers through the earlier availability of these medicines.

• change the regulation of complementary medicines that will allow consumers to make more informed product choices, including a new assessment pathway for efficacy-assessed listed complementary medicines. Reforms include the establishment of a list of permitted indications and an exclusivity period for new ingredients. Consultation will occur in late 2017 on recommendations to support the use of a new efficacy-assessed assessment pathway with a pilot of the assessed listed medicines pathway to occur in 2018.

• introduce significant reforms to streamline the advertising framework for therapeutic goods, including establishing a single, centralised complaint handling system managed by the TGA from 1 July 2018 with external review of the complaints model after three years. Consultation will occur in late 2017 on principles to be adopted in a new Therapeutic Goods Advertising Code from mid-2018 and the Code itself will be consulted on in early 2018. An education program to support compliance will be undertaken in early 2018 and will cater to different audiences including sponsors, health practitioners and the community through guidance and other material.

• strengthen and broaden the range of investigation and enforcement powers relating to compliance and monitoring. These amendments will standardise monitoring, investigation, infringement notices and injunctions to align with comparable Commonwealth regulators and government policy.

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Timeframes for implementation are subject to Parliamentary processes and anticipated passage of the proposed amendments.

Stakeholder consultation will continue throughout 2017–18, through both targeted and public consultations, to inform options for implementation. Additionally, guidance material and industry workshops will be developed to support understanding of the changes to the regulatory framework and regulatory requirements.

A significant program of IT work is supporting implementation of the reforms, focusing on improvements to supporting software and the development of new IT capabilities.

There are a range of other reforms forecast for delivery in 2017–18 to support better health outcomes for Australians and to reduce regulatory burden. An overview of our 2017–18 activities is provided in the table below.

Regulatory reform activities for 2017–18

Outcome Activities

Prescription medicine reforms

• Develop and implement expedited pathways (priority review and provisional approval) for the registration of novel prescription medicines that address unmet clinical needs

• Undertake priority review designations and assessments of certain new prescription medicines

• Develop supporting IT systems for provisional medicines registration applications

• Implement a revised risk-based process for evaluating variations to registered medicines, specifically the introduction of a notification process for low risk variations

• Expand the list of variations approved for processing as notifications to include biologicals and additional registered medicines

• Re-format Product Information documentation

Complementary and over-the-counter medicine reforms

• Implement the permitted indications reforms for listed complementary medicines

• Implement the new assessed listed medicines pathway including development of: - evidence guidelines to support the new pathway - a claimer for assessed complementary medicines

• Introduction of a market exclusivity period for new ingredients approved for use in listed medicines

Biologicals reforms • Enhance our regulatory framework for biologicals to align with changes made to medicines regulation including publishing guidance on Risk Management Plans for biologicals



Outcome Activities

Medical device reforms • Commence a priority review pathway for medical devices• Establish a process for Australian designated bodies to undertake

conformity assessments of medical devices• Implement criteria to identify comparable overseas regulators for

the approval of medical devices • Propose initial regulatory amendments to harmonise medical

devices regulation, focused on safety concerns, with the European Union regulatory framework

• Undertake a review of the range of products currently classified as Class I medical devices

Post-market monitoring reforms

• Update guidance on pharmacovigilance requirements of medicine sponsors for products on the ARTG and identify mechanisms for enhancing compliance

• Upgrade the database for collecting and analysing adverse events to allow more effective international sharing of information and improved signal detection

• Incorporate expanded classification of adverse events, via work on the International Medical Devices and Regulators Forum working groups, to improve international sharing of information

• Implement the Black Triangle Scheme for new medicines• Implement a new Adverse Event Management System• Access linked datasets including Prescription Sequence Symmetry

Analysis and 45 and Up projects

Access to unapproved therapeutic products reforms

• Implement policies, processes and systems for electronic applications and/or notifications

• Undertake compliance assessments of the new SAS Category C notification pathway

• Develop an external application portal for the SAS and Authorised Prescriber scheme

Scheduling Policy Framework and advertising of pharmacist only medicine reforms

• Revise Scheduling Policy and companion handbook to improve the efficiency and transparency of the scheduling process

• Update guidelines and reform the advertising of S3 (pharmacist only medicines) substances

Advertising of therapeutic goods reforms

• Introduce a new Advertising Code for therapeutic goods• Establish a single complaints management process• Design and implement a new IT system for advertising complaints

management• Develop and implement a sponsor education program to support

compliance• Work towards revised compliance and monitoring powers in the

Therapeutic Goods Act 1989

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Outcome Activities

International cooperation and work sharing reforms

• Develop frameworks to support increased use of overseas reports and work-sharing arrangements in making regulatory decisions and criteria to identify comparable overseas regulators for prescription medicines

• Make effective use of external expertise and regulatory science initiatives led by other regulators

• Improve understanding of international regulators’ processes to increase opportunities for collaboration, for example: - collaborate through the Australia-Canada-Singapore-

Switzerland Consortium, particularly on the generic medicines work sharing trial

- greater use of safety evaluations for new complementary medicine ingredients performed by overseas regulators, including with Canada, Singapore and Switzerland

- progress work sharing opportunities for medicines, including with Health Canada, through the Regulatory Cooperation Initiative

• Continue the Trans-Tasman cooperation between regulatory schemes through: - enhanced information sharing in regulatory compliance and

pharmacovigilance, laboratory tests, investigations into quality defects or manufacturing errors and recall actions undertaken

- continued sharing of a common approach to over-the-counter medicine pre-market business processes

- further mutual recognition of TGA and Medsafe GMP inspections of manufacturers


International engagementWe are committed to advancing Australia’s health interests through international engagement, as detailed in the Therapeutic Goods Administration International Engagement Strategy 2016-2020, by:

• contributing to public health and safety through regulation• working with others to improve the regulatory system• participating in work sharing and convergence activities.

In an increasingly globalised world, Australia’s health policy must respond to the evolving international context. Our international collaborative activities build synergies with overseas regulators and improve health and safety as a result of enhanced efficiency and effectiveness of our regulatory system. These activities benefit the TGA and our international counterparts by providing opportunities to work with others to improve the regulatory system and participate in work sharing and convergence activities. Tangible benefits include reduced regulatory burden, evaluation time and cost, as well as data and facilities inspection information sharing. This helps to address global challenges and emergencies.

Our continued participation in fora such as the International Coalition of Medicines Regulatory Authorities (ICMRA) and the International Medical Devices Regulators Forum (IMDRF) provides us with the opportunity to influence international policy.

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In 2017–18 the Australian Government, through the TGA and the Department of Foreign Affairs and Trade (DFAT), will pilot a program that will give Pacific Island Countries access to the Australian laboratory testing program for medicines quality assurance. Medicines will be tested by our Laboratories Branch with funding provided by DFAT. The TGA will also partner with DFAT in a rigorous regulatory strengthening program to be designed during 2017–18.

Details of the international activities for which the TGA is a contributor are outlined in the following table.

International engagement activities for 2017–18

Outcome Activities

Knowledge sharing • Continue as co vice-chair of the ICMRA and lead its pharmacovigilance project to enhance knowledge sharing between medicines regulatory authorities

• Contribute to regional capacity building through participation in fora such as the Regional Alliance Steering Committee for National Regulatory Authorities for Vaccines

• Continue to contribute to influencing the development and harmonisation of international regulatory standards through strategic engagement with, for example: - European Medicines Agency - International Council for Harmonisation of Technical

Requirements for Pharmaceuticals for Human Use - World Health Organization - Pharmaceutical Inspection Convention and Pharmaceutical

Inspection Co-operation Scheme - International Organisation for Standardisation Standards

• Continue to participate in fora to further cooperation, for example: - Australia, Canada, Singapore and Switzerland Consortium - International Medical Devices Regulators Forum - Medical Device Single Audit Program - International Generic Drugs Regulators Programme - Internal Pharmaceutical Regulators Forum - Regulatory Cooperation Initiative

• Identify new opportunities for augmenting our international engagement


International engagement activities for 2017–18

Outcome Activities

Work sharing and convergence

• Develop protocols and criteria for exchange of manufacturing inspection information with trusted international regulators for example through the Medical Device Single Audit Program

• Progress opportunities for work sharing with Health Canada on GMP inspections and desktop assessments

• Continue our participation in the Pharmaceutical Inspection Corporation Scheme (PICS) with the objective of leading the international development, implementation and maintenance of harmonised GMP standards and quality systems of inspectorates for medicines

• Identify opportunities for work sharing with other trusted international regulators

Support global health outcomes

• Contribute to the reduction in the number of new cases, and improved treatment of, malaria in the Asia-Pacific by: - co-chairing the Asia Pacific Leaders Malaria Alliance regulators

working group - supporting the timely market authorisation of new medicines and

diagnostics for malaria therapy in the Asia-Pacific region• Assist in coordinated responses to global health emergencies

through our contribution to ICMRA’s efforts to strengthen the quality, safety and efficacy of medicinal products globally

• Provide Pacific Island Countries access to Australian laboratory testing for medicines quality assurance

• Continue to work with DFAT to expand the testing program to include additional Pacific Island Countries

Therapeutic Goods AdministrationPO Box 100 Woden ACT 2606 Australia

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

https://www.tga.gov.au

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