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TGA reforms: A blueprint for TGA's future: Progress report as at 31 December 2014

8 April 2015

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Appendix A: TGA Reforms - Blueprint recommendation status

Key Implemented On track Material delayed
Recommendations relating to communication and stakeholder engagement
Blueprint recommendations addressed Achievements 1 Jan 2012 - 31 Dec 2014 Planned activity/next steps 1 Jan - 30 Jun 2015
Transparency Review Rec 1 - Establish an Australian Therapeutic Goods Advisory Council, with membership representative of major stakeholder groups, to enable more effective stakeholder input into future directions and program implementation. The Council will have an oversight role in the implementation, ongoing monitoring, and evaluation of the recommendations of this review.

Implemented.

The Australian Therapeutic Goods Advisory Council (the Council) held its inaugural meeting in 2012. Meetings were also held in February 2013, August 2013, February 2014 and August 2014. The Council provides an oversight role in the implementation, monitoring and evaluation of the Blueprint recommendations.

The Council will next meet in February 2015.
Transparency Review Rec 2 - Define, adopt and publish consultation principles to guide regulatory transparency and accountability.

Implemented.

Development of two consultation documents. TGA Consultation Principles and TGA Consultation principles - A Guide for Staff have been finalised and published. A strategy and schedule for participating in events to raise awareness of the TGA has been developed. Participated in a number of public events and conferences.

These principles are being used to guide regulatory transparency and accountability.
Transparency Review Rec 3 - Develop and implement a comprehensive communication strategy to inform and educate. A dedicated communications team should be established within TGA to implement that strategy.

Implemented.

Communication team established and resourced. Development and publication, of the TGA External Communication and Education Framework: Priorities and Projects 2013-15 occurred in 2012, and was rolled out in 2013. Development of an accompanying guide for TGA staff.

Published reports on market research conducted in relation to TGA communication activities in 2013.

Continue to work on projects outlined in TGA External Communication and Education Framework: Priorities and Projects 2013–15.
Transparency Review Rec 4 - Work transparently with other key providers of information to enhance the information available to the public consistent with the principles of the quality use of medicines.

Implemented.

Partnerships with key information providers (including the NPS, Australian Commission on Safety and Quality in Health Care and Australian Medical Association) have been formalised. Letters sent to 56 organisations inviting them to link to material on the TGA website. Consultations with other major information providers have been conducted in the context of the development of the communication and education strategy. Initial focus has been the identification of priorities and opportunities for collaboration.

Worked in partnership with NPS to create and disseminate information on topics such as biosimilar medicines.

Stronger relationships developed with Australian universities. This includes publishing on the TGA website a series of education modules for final year University students on the work of the TGA, and TGA presentation of lectures at university partners.

Major work commenced on the dissemination of education materials identified above, as part of the ongoing work under the Communications and Education Framework.

Participated in numerous public events and conferences. A major function at Parliament House recognising 50 years of independent expert advice on prescription medicines.

We will also continue our conference activities including, high-profile participation as keynote speakers for major industry and healthcare professional conferences.

Transparency Review Rec 5 - Develop a plan to ensure information on the key public access portal, the TGA website, is current, accurate, relevant, timely and up to date, and meets the needs of its audiences.

On track.

The Public Contact Team implemented. Identification of the most common public enquiries received, to inform the further development of the TGA website and improvements to handling of enquiries.

New TGA website homepage launched in November 2013. General improvements to the accessibility of information on the TGA website. A tender process commenced to upgrade the website.

Communication about TGA's post-market regulatory activities on the website strengthened through the launch of databases of adverse events and recalls. An early warning system to inform consumers of potential safety issues.

Mobile device version for viewing the full TGA website on devices and smartphones has been launched.

Users can now search the Australian Register of Therapeutic Goods from the TGA website.

Six videos have been published on the TGA website on:

  • the role of the TGA (for consumers and for health professionals)
  • the risk versus benefit approach we take to regulating therapeutic goods
  • information about higher- and lower- risk medicines (AUST R and AUST L)
  • travelling with medicines and medical devices; and
  • a summary of supplying therapeutic goods in Australia

First education materials were available via social media.

The website Content Management System has been upgraded.

Continue to use information gathered through sources such as the Public Contact Team and other enquiries to TGA to identify needs of TGA's stakeholders.
Transparency Review Rec 6 - The TGA provide user-friendly information on the risk based framework under which it operates, including detailed explanations of how this operates for different classes of therapeutic goods. As a priority, the differences between registered and listed therapeutic goods, and their processes of evaluation, should be explained.

Implemented.

A clear explanation of the TGA's risk based framework for therapeutic goods has been published on the TGA website. Explanation of benefits vs risk approach to regulating therapeutic goods is a particular focus of the External Communication and Education Framework and addressed in several subprojects. New education materials for consumers and health professionals providing information on higher and lower risk medicines have been developed and tested with target audiences.

New education materials for consumers and health professionals have been published that specifically describe how we evaluate products and manage risk.

Transparency Review Rec 7 - The TGA implement mechanisms to educate and inform the public that listed medicines are not evaluated for effectiveness by the TGA prior to market.

Implemented.

The TGA is working in partnership with other information providers to achieve a wider public understanding that listed medicines are not evaluated for effectiveness by the TGA prior to market. The booklet "Listed medicines - The role of Australia's medicines regulator" has been published on the website, and distributed to consumer and health professional groups.

New education materials on role of the TGA, risk based approach to regulation and higher and lower risk medicines have been published that specifically describe how we evaluate products and manage risk.

Transparency Review Rec 8 - The TGA provide clear information on the role of its statutory advisory committees, and adopt a consistent and transparent approach to the publication of information from those committees.

Implemented.

Publication on the TGA website of a statement clarifying the role of advisory committees in the context of the TGA's regulatory decision making process. A standardised template developed for commissioning expert advice from committees.

A consistent and transparent approach to the publication of committee meeting information has been implemented. Principles for the publishing of committee meeting information have been developed and implemented with the issuing of a meeting statement for all committee meetings from 2013.

More comprehensive meeting information has been published during 2014. The initial focus has been on TGA's post-market advisory committees as 'For Official Use Only' issues constrain full public reporting of advice from pre-market advisory committees.

Transparency Review Rec 9 - The TGA improve access and quality of information on the processes for regulation of advertising of therapeutic goods, including the complaint process and the outcomes of complaints.

Material variation.

Development of specifications for the development of a complaints handling IT system, including a reporting function. A consultation on options for reforms to the advertising framework closed on 12 July 2013. Public submissions in response to the consultation RIS reviewed and possible improvements submitted to government to inform the next steps.

Refer to Advertising reforms - rec 2.

Development of a workflow system for advertising complaints has progressed to user acceptance testing phase. Documentation for workflow system implementation for advertising complaints has been finalised.

Consideration of possible regulatory changes will be considered through the Expert Review of Medicines and Medical Devices Regulation.
Transparency Review Rec 10 - The TGA, in conjunction with key stakeholders, develop and publish agreed Key Performance Indicators to provide quantitative and qualitative information on the TGA's organisational effectiveness and operational efficiency.

Implemented.

The Australian Therapeutic Goods Advisory Council and TGA-Industry Consultative Committee consulted on the Key Performance Indicators.

Key Performance Indicators and reporting measures for providing information on TGA's organisational effectiveness and operational efficiency have been published on the TGA website.

Phased implementation of reporting against Key Performance Indicators began, with reporting against KPIs for the period July-Dec 2013 published in March 2014.

Initial public reporting against the full set of Key Performance Indicators occurred in August 2014.

Six-monthly reports on the Key Performance Indicators will continue.

Review and revise KPIs to ensure they address the common set of performance measures required as part of the Government's new Regulator Performance Framework.

Transparency Review Rec 11 - Develop and publish a policy on the disclosure of commercially confidential information, noting significant issues for each therapeutic product type. The policy should take into account the practices followed by comparable international regulators.

Implemented.

Following formal consultation from other international regulators, industry and interested parties the document "TGA Approach to disclosure of commercially confidential information" was finalised providing guidance as to how official information of a business or commercial nature, provided to the TGA, is treated.

References to 'commercial in confidence' have been changed to 'For Official Use Only' in relevant TGA forms.

A link is provided to an explanatory statement on the treatment by the TGA of information (including commercially confidential information).

Finalise the guidance documents on the TGA website to remove references to commercial-in-confidence as guidance documents are reviewed.

Provide links from all therapeutic area webpages to the commercial-in-confidence material on the TGA website.

Transparency Review Rec 12 - The TGA explore mechanisms for providing explanations on its various regulatory processes, and the TGA adopt publication principles on the outcomes of application assessments, using as an exemplar the Australian Public Assessment Reports (AusPAR).

Implemented

The Australian Regulatory Guidelines for Prescription Medicines and its appendices have been updated and published.

Over-the-Counter medicines guidelines updated and published, reflecting reformed pre-market evaluation processes.

New format developed for presenting regulatory guidelines on the web which is simpler for applicants to use and for the TGA to update.

Developed a new concept for explaining the various regulatory processes for the therapeutic goods industry.

Developed a program for updating regulatory guidelines using the new web based format.

Ongoing review, updates and maintenance to regulatory guidance will occur as part of business as usual activity.
Transparency Review Rec 13 - Assess the feasibility of developing an on-line system for the submission and tracking of all applications for assessment, which enables the sponsor to ascertain the progress of an application.

Implemented.

The TGA electronic Business System (eBS) allows sponsors to see what stage applications are up to.

The supporting documentation for medicine applications is large and complex. The TGA published technical specifications for electronic Common Technical Document (eCTD) submissions. These specifications were then used as part of a pilot and TGA successfully received eleven electronic submissions.

TGA consulted and received comments from industry on the draft eCTD specifications.

The TGA will develop and publish final specification and guidance material for eCTD submissions so that industry can develop electronic submission systems.

The TGA will assess the readiness of industry and the TGA to submit and receive these dossiers in the eCTD format.

Transparency Review Rec 14 - The TGA work with stakeholders to improve labelling and packaging requirements to educate and assist consumers and health practitioners to make informed decisions about the quality use of therapeutic goods.

On track.

Stakeholder consultation on an initial paper on proposed regulatory changes to the labelling and packaging of medicines to address consumer safety risks completed. Paper on evidence base published, along with discussion paper on options for regulatory change.

A revised Therapeutic Goods Order (TGO) has been drafted.

Public consultation was undertaken on the general requirements for medicines, including proposed options in the Regulatory Impact Statement.

Submissions have been reviewed.

Publish submissions on TGA website.

Revise TGO based on feedback received from public consultation.

Consult with stakeholders on proposed changes, and seek advice from Government on next steps.

Transparency Review Rec 15 - The TGA conduct, and report on, a feasibility study into the development of an early post-marketing risk communication scheme for therapeutic goods, with consideration of international models.

Implemented.

An assessment of international models was undertaken. Stakeholder consultation on the feasibility of implementing a new-to-market risk communication scheme which signals to people using therapeutic products that a particular product is new, or newly available for a particular use.

This work is to be further progressed in the context of the ongoing maintenance and accuracy of Approved Product Information (PI) and Consumer Medicines Information (CMI) (see comment on Transparency Review Rec 17).
Transparency Review Rec 16 - The TGA actively promote the distribution of therapeutic goods safety information, and examine mechanisms for improving the timely communication of alerts and recalls, to health practitioners and to consumers.

On track.

Development, with Medsafe NZ, of a common approach to capturing, management and publication of recall information. The System of Australian Recall Actions providing access to information about recalls action that have been undertaken in Australia The Recall Portal provides access to information about recall actions occurring in Australia and New Zealand. Both databases hold information on Australian recall actions from 1 July 2012.

The Early Warning System (EWS) webpage was launched providing information on potential safety concerns.

The TGA has identified a number of areas for improvement to the updated Uniform Recall Procedure for Therapeutic Goods (URPTG) and has prepared consultation documentation.

Consultation is expected to be undertaken with a view to finalising the updated URPTG.
Transparency Review Rec 17 - The TGA explore mechanisms to maintain the currency of Consumer Medicines Information (CMI) and Approved Product Information (PI).

Implemented.

Stakeholder consultation on the development of proposals to improve access to, and the currency of, PI and CMI to foster quality use of medicines. Consultation included public consultation and industry consultation workshops.

Advice has been provided to Government based on the consultations.

The Registered Indications Reference Group met in September to consider issues relating to updating registered indications for prescription medicines as they relate to off-label use. The initial focus has been on three medicines (ramipril, dacarbazine and tamoxifen).

A broader reference group will focus on identifying potential solutions to reduce barriers to updating registered indications for prescription medicines in the longer term.
Transparency Review Rec 18 - The TGA progressively develop and implement a system to publish the outcomes of investigations and compliance actions taken.

Implemented.

Information on listed complementary medicines cancellations from the ARTG following compliance reviews, including the grounds for cancellation have been published on the TGA Website since October 2012. TGA published a description of its regulatory compliance framework.

Continue to progressively publish outcomes of compliance actions across a fuller range of product types.
Transparency Review Rec 19 - The TGA more effectively facilitate the recognition and reporting of adverse events by health practitioners and consumers, and promote the adverse event reporting system.

Implemented.

Strategy to increase consumer and health professional awareness of, and participation in, the adverse event reporting system is being implemented. The strategy includes activities to:

  • promote adverse event reporting
  • educate health professionals about how and why to report adverse events
  • improve access to reporting methods

Online education activities for health professionals about adverse event reporting relating to medicines, vaccines and medical devices.

Online consumer form developed for consumers to report adverse events.

Develop materials to improve consumer and health professional awareness of adverse event reporting.
Transparency Review Rec 20 - The TGA make its Adverse Events Database available to and searchable by, the public in a manner that supports the quality use of therapeutic goods.

Implemented.

The public have access to Australian and New Zealand medicines and medical device adverse events data through the release of publicly-searchable databases - the Database of adverse events (DAEN) on TGA.gov.au and the Joint Adverse Event Notification System on ANZTPA.org.

Transparency Review Rec 21 - The TGA work with State and Territory governments, stakeholders, and other relevant agencies, to improve the visible management of adverse event reporting in support of consumer safety and consistent with the findings of the Horvath Review into Immunisation.

Implemented.

Work with the Office of Health Protection (Department of Health), States and Territories has resulted in a better two way exchange of information about adverse events following immunisation (AEFI), including: intensive monitoring of influenza vaccines; enhanced surveillance of Gardasil to include males; and preparation for enhanced surveillance for the new combined measles-mumps-rubella-varicella vaccine.

Two searchable databases provide public access to Australian and NZ medicine adverse event data (including for vaccines) and medical devices adverse event data.

An Advisory Committee on the Safety of Vaccines (ACSOV) has been established advising both the TGA, on regulatory aspects of vaccine safety, and the Office of Health Protection, on national program aspects.

Strategy to increase consumer and health professional awareness of, and participation in, the adverse event reporting system is being implemented.

The Advisory Committee on the Safety of Vaccines (ACSOV) will continue to advise both the TGA, on regulatory aspects of vaccine safety, and the Office of Health Protection, on national program aspects.
Recommendations relating to complementary medicines
Blueprint recommendations addressed Achievements 1 Jan 2012 - 31 Dec 2014 Planned activity/next steps 1 Jan - 30 Jun 2015

Auditor-General's Report - Rec 1 - To achieve timely completion of key guidance material for complementary medicines,

  1. provide a target date for the completion and publication of each key guidance document.
  2. provide regular progress reports on the development of key guidance documents on the TGA website, to keep industry, health professionals and consumers informed.

Implemented.

Target dates for the completion of each key guidance document published. Regular progress reports on the development of the key guidance documents published. An update to the Australian Regulatory Guidelines for Complementary Medicines has been finalised and published. Revised Evidence Guidelines were published.

Auditor-General's Report - Rec 2 - To improve the integrity of the self-assessment process for listing complementary medicines on the Australian Register of Therapeutic Goods, the ANAO recommends that Health seeks to finalise work on the 'coded indications' project so as to limit the use of inappropriate claims and indications on the ARTG.

Material variation to delivery.

Public and industry consultations held on permitted (coded) indications. Development of enhancements to Electronic Listing Facility (ELF) application portal to enable implementation of the proposed changes.

The TGA has worked with industry on updating a comprehensive list of indications which meets the needs of the complementary medicines industry and improves compliance with the regulatory framework.

Options for reform of the regulation of complementary medicines will be considered by the Expert Review of Medicines and Medical Devices Regulation.
Auditor-General's Report - Rec 3 - TGA makes information available in a timely manner to the Australian public, for each listed complementary medicine, stating whether it has been subject to post- market review by the TGA, when it was reviewed, and the outcome of that review.

Implemented.

Publication of a Compliance Review Framework on the TGA website.

Regular publication on the TGA website of listed complementary medicines cancelled as a result of compliance reviews.

Information on the cancellations of listed complementary medicines following post-market reviews will be published on the TGA website.

Auditor-General's Report - Rec 4 - To improve compliance with the regulatory framework, the ANAO recommends that the TGA:

  1. use its random sampling review of listed medicines to develop risk profiles of sponsors and the most significant characteristics of medicines
  2. use the profiles to inform its program of post-market reviews.

Implemented.

IT reporting system for post-market reviews developed. Risk profiling begun.

Data collected from listing compliance reviews will be used to develop risk profiles to prioritise future compliance review activity.
Auditor-General's Report - Rec 5 a - The ANAO recommends that the TGA adopt a standard operating procedure for completing investigations of advertising breaches, incorporating: appropriate timeframes for completing the investigations of advertising breaches; in non- compliance.

Implemented.

A standard operating procedure for investigating advertising breaches is in place.

Auditor-General's Report Rec 5 b - The ANAO recommends that the TGA adopt a standard operating procedure for completing investigations of advertising breaches, incorporating: provision of regular reports to the TGA executive on progress with investigations and trends in non- compliance.

Implemented.

Business requirements reviewed and functional specifications for the development of a new advertising workflow system finalised.

A workflow system for advertising complaints, to facilitate regular reporting to the TGA Executive progress with complaint investigations and trends in non-compliance.

Reports will be considered by the TGA’s Regulatory Compliance Committee.
Informal Working Group Rec 1a - Provide increased information on product labels regarding regulatory assessment undertaken by TGA of complementary medicines.

Implemented.

Options in this area were considered in 2012-13 and it was decided not to progress changes at this time.

Transparency Recommendation 7 ("educate and inform the public that listed medicines are not evaluated for effectiveness by the TGA prior to market") will continue to be pursued.
Informal Working Group Rec 1b - Provide increased information on TGA website regarding regulatory assessment undertaken by TGA of complementary medicines.

Implemented.

See comment on Auditor General’s Report Rec 3 above.

Informal Working Group Rec 2a - Modify Electronic Listing Facility system, to include restriction or elimination of access by sponsors to 'free text'.

Material variation to delivery.

Proposed legislative amendments associated with the permitted (coded) indications for listed medicines are on hold.

Options for reform of the regulation of complementary medicines will be considered by the Expert Review of Medicines and Medical Devices Regulation.
Informal Working Group Rec 2b - Modify Electronic Listing Facility system, to provide guidance and cautionary notes for sponsors using the Electronic Listing Facility, regarding the consequences of misleading and unsubstantiated claims.

Implemented

Guidance and cautionary notes have been included in the Electronic Listing Facility system.

Informal Working Group Rec 3 - Update 'Guidelines for levels and kinds of evidence' and include 'Guidelines for levels and kinds of evidence' in regulation.

Implemented.

The Evidence Guidelines document has been revised following two rounds of consultation. Options to include the Evidence Guidelines in regulation were considered and it was decided not to progress changes at this time.

Informal Working Group Rec 4 - Review current 'coded indications' project based on the document 'Guidelines for levels and kinds of evidence' and either restrict or eliminate access by sponsors to 'free text' in the Electronic Listing Facility.

Material variation to delivery.

See comments on Auditor-General's Report Rec 2 and Informal Working Group Rec 2a above.

Informal Working Group Rec 5 - Apply, enforce and publicise sanctions and penalties, including for advertising breaches, including recalling products from the market that are removed from the ARTG as a result of regulatory action.

Implemented.

Regulatory Compliance Framework published.

Informal Working Group Rec 6 - Enhance sanctions and penalties for repeated breaches of non- compliance (as well as strengthening sanctions and penalties for advertising).

On track.

Refer to Advertising Rec 2.

Recommendations relating to medical devices
Blueprint recommendations addressed Achievements Achievements 1 Jan 2012 - 31 Dec 2014 Planned activity/next steps 1 Jan - 30 Jun 2015

Medical Device Reforms - Proposal 1 Reclassification of joint replacement implants.

Implemented.

Joint replacement implants re-classified as of 1 July 2012, with a two year transition period concluding on 30 June 2014. Industry and health care practitioner information sessions held.

Transition period has been extended to 30 June 2015. TGA will continue to work with the Medical Technology Association of Australia, the Australian Orthopaedic Association and other stakeholders to resolve issues to ensure the continued availability of orthopaedic devices that are safe and perform as intended. This includes regular communications with industry about the changes and required next steps as well as liaison with healthcare professionals using these products.

Medical Device Reforms

Proposal 2a - Use of third party assessment bodies for Australian manufacturers.

Proposal 2b - Increasing pre-market scrutiny for implantable medical devices.

Proposal 2c - Recognition of third party assessment bodies.

Implemented.

The Regulatory Impact Statement: Changes to premarket assessment requirements for medical devices was released on 1 August 2013, outlining proposals to enhance premarket scrutiny of the higher risk devices, publication of medical device regulatory decisions, and removing the requirement for TGA conformity assessment for Australian medical device manufacturers.

Australian medical device manufacturers are able to used conformity assessment certification from European notified bodies when making applications to the TGA.

Medical Device Reforms - Proposal 3(i) - Amend the way in which a kind of medical device is included in the ARTG.

Implemented.

Stakeholder views have been sought on exploring alternative ways to improve traceability of medical devices. International developments and the emerging e-Health agenda are being considered in developing alternate options to amending the way devices are included on the ARTG.

The advantages and efficiencies through a global approach in providing international Unique Device Identifiers in Europe and the USA will be harnessed.

Medical Device Reforms - Proposal 4 - Publication of device product information on the TGA Website.

Material variation to delivery.

The RIS exposure draft addressing Proposal 2 incorporated an intention to seek stakeholder views on publication of an AusPAR style document for medical devices.

Possible regulatory changes will be considered by the Expert Review of Medicines and Medical Devices Regulation.
Recommendations relating to advertising of therapeutic products to the general public
Blueprint recommendations addressed Achievements 1 Jan 2012 - 31 Dec 2014 Planned activity/next steps 1 Jan - 30 Jun 2015
Advertising Consultation - Rec 1 Publish the report on advertising reform on the website, once finalised.

Implemented.

The Advertising Regulatory Framework - Options for Reform report published on the TGA website in May 2012.

Advertising Consultation - Rec 2 - Reforms to advertising framework.

Implemented.

Public consultation paper incorporating proposals for future regulation of advertising - "Consultation Regulation Impact Statement - Regulating the advertising of therapeutic goods to the general public" (consultation RIS) closed on 12 July 2013. 1276 public submissions in response to the consultation RIS reviewed and submitted to Government options for improvements to the regulatory arrangements for the advertising of therapeutic goods to the general public.

Advertising Consultation - Rec 2a - Modify pre-approvals process to include medical devices and pay TV (advertising claims about the efficacy of a product to be assessed by the TGA).

Implemented.

See comment on Advertising Rec 2 above.

Advertising Consultation - Rec 2b - Establish a single entry point for all complaints, with some handled by TGA (complaints about the efficacy of a product to be assessed by the TGA).

On track.

The public consultation paper - "Consultation Regulation Impact Statement - Regulating the advertising of therapeutic goods to the general public" (consultation RIS) which closed on 12 July 2013 incorporated consideration of a single entry point.

Possible regulatory changes will be considered by the Expert Review of Medicines and Medical Devices Regulation.
Advertising Consultation - Rec 2c - Develop a more effective approach to sanctions and penalties (including use of the infringement notice provisions).

Implemented.

See comment on Advertising Rec 2 above.

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