TGA reforms: A blueprint for TGA's future: Progress report as at 31 December 2012
Appendix: TGA reforms: Blueprint recommendation status
| Key | Recommendation completed | On track | Completion potentially delayed |
|---|
| Blueprint recommendations addressed | Outputs 1 Jan - 31 Dec 12 | Planned outputs 1 Jan - 30 Jun 13 |
|---|---|---|
| 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. |
Completed. Announcement, selection of members for the Australian Therapeutic Goods Advisory Council (the Council). The Council held its inaugural meeting in 2012. |
The Council will meet early in 2013 and continue to meet twice a year. |
| Transparency Review Rec 2 - Define, adopt and publish consultation principles to guide regulatory transparency and accountability. |
On track. Development of two draft consultation documents. TGA Consultation Principles and TGA Consultation Principles - A Guide for Staff. |
On track. Finalisation and release, of consultation documents. |
| 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. |
Completed. Communication team established and resourced. Development and publication, of the TGA External Communication and Education Framework: Priorities and Projects 2013-15 occurred in 2012. Development of an accompanying guide for TGA staff. |
Implementation of new framework. |
| 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 |
On track. 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. |
On track. Continue work with NPS and other information providers to establish agreement on the provision of information and development of initial joint projects. |
| 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. Improvements, to the e-Business Services (eBS) website implemented to make it easier to find information in the Australian Register of Therapeutic Goods (ARTG) and permit storage and analysis of search results. Commencement of a dedicated Public Contact Team pilot. Identification of the most common public enquiries received, to inform the further development of the TGA website and improvements to handling of enquiries. General improvements to the accessibility of information on the TGA website. |
On track. Evaluating the effectiveness of information on the TGA website in meeting the communication and information needs of key stakeholders. Refinement of Public Contact Team model. |
| 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. |
Completed. 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. |
Further work to develop a media plan to communicate the TGA's risk based framework more broadly. |
| 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. |
On track. To commence following release of External Communication and Education Framework. The TGA to work 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. |
|
| 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. |
Completed. 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. |
Ongoing work includes development of a standardised template for commissioning expert advice from committees. Principles for the publishing of committee meeting information, including agendas and deliberations (where appropriate) will also be developed. |
| 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. |
On track. Development of specifications for the development of a complaints handling IT system, including a reporting function. Public discussion paper released and policy options for future regulation of advertising developed for discussion with Parliamentary Secretary. |
On track. Regulation Impact Statement developed and public consultation on advertising regulation options. Development of improved information on advertising regulation including a publicly accessible database containing information on complaints and their outcomes; publishing decisions on advertising matters, including any advertising sanctions. |
| 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 |
On track. Develop Key Performance Indicators providing information on TGA's organisational effectiveness and operational efficiency. |
|
| 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. |
On track. Completion of a stock-take of the circumstances in which the TGA holds commercially confidential information and of a comparative analysis of international approaches. Circulation of a paper and lead session on handling of Commercial-in-Confidence material to participants of the Summit of Heads of Medicines Regulatory Agencies. |
On track. Circulation of a policy paper for stakeholder feedback, describing the TGA's approach to managing commercially confidential information. |
| 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). |
On track. The appendices to the Australian Regulatory Guidelines for Prescription Medicines have been updated and formatted in web styles for web pages. Guidance documents relating to the streamlined submission process have been edited and formatted in web style for internal review. Where possible, guidance on regulatory processes common to other medicines has been amalgamated into one document. Identified guidance to be drafted for processes that are pre-requisites to submitting the applications. |
On track. Review acronyms and terminology in guidance documents, and deletion of superseded documents. Usability testing, in the first quarter of 2013, of user friendly explanations and website navigation relating to processes to register a prescription medicine. Implementation of outcomes of the review of business processes for making minor variations to prescription medicines. Commencement of development of explanations of other regulatory processes. |
| 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. |
On track. Request for Tender documents to implement an electronic Common Technical Document (eCTD) Review Tool published and tenders closed. |
On track. Evaluation of eCTD systems and selection of appropriate system. Commence work on development of system to make information available to sponsors on the status of applications. |
| 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. |
Completion potentially delayed. Stakeholder consultation on an initial paper on proposed regulatory changes to the labelling and packaging of medicines to address consumer safety risks completed. |
Completion potentially delayed. Paper on evidence base published, along with discussion paper on options for regulatory change. Completion of second phase of stakeholder consultation, and finalisation of proposals for policy approval. A revised Therapeutic Goods Order (TGO) may be drafted by 30 June 2013. |
| 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. |
On track. Development, with Medsafe NZ, of a common approach to capturing, management and publication of recall information, based on international best practice. |
On track. Stakeholder consultation will be followed by adoption of an early post marketing system to increase awareness of products recently registered for the Australian market. |
| 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. |
On track. Stakeholder consultation on the development of a trans-Tasman early warning system for advising the public of investigations into potential safety risks associated with medicines and medical devices. Consultation, with State and Territory Governments, industry, health professionals and consumers on a streamlined recall process. Design of a Publicly searchable database of Recall Actions. |
| Transparency Review Rec 17 - The TGA explore mechanisms to maintain the currency of Consumer Medicines Information (CMI) and Approved Product Information (PI). |
On track. Stakeholder consultation on the development of proposals to improve access to, and the currency of, PI and CMI to foster quality use of medicines. |
|
| Transparency Review Rec 18 - The TGA progressively develop and implement a system to publish the outcomes of investigations and compliance actions taken. |
On track. 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. |
On track. Broader communication of outcomes of investigations and time frames for completing the investigations of breaches. |
| 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. |
On track. Review of current systems for reporting and promotion to identify possible improvements completed. Release of an online system for the reporting of problems with medical devices. Booths at key health professional conferences focusing on promoting adverse event reporting. |
On track. Development of a strategy to increase consumer and health professional awareness of, and participation in, the adverse event reporting system. |
| 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. |
Completion potentially delayed. The public have access to Australian and New Zealand medicines adverse events data through the release of publicly-searchable databases in 2012. |
Completion potentially delayed. Completion of the database development for adverse events relating to medical devices requires a change to how device data (including device naming) is captured by the TGA. This requires significant modification of proprietary software packages, along with industry consultation and user acceptance testing. |
| 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. |
On track. Provision of information on seasonal influenza vaccines for use in children and encouragement of health professionals and consumers to report all adverse events associated with influenza vaccinations. Provision of public access, through the release of a searchable database, to Australian and NZ medicine adverse event data (including for vaccines). Establishment of the Advisory Committee on the Safety of Vaccines (ACSOV). |
On track. Development with State and Territory Chief Officers and Council of Australian Therapeutic Advisory Groups (CATAG) on options and with Medicare Locals and RACGP for strengthened adverse event reporting in primary and hospital care respectively. Inaugural meeting of ACSOV held. Development of templates for nationally consistent reporting of adverse events following immunisation. Communication program to raise professional and consumer awareness of vaccine safety monitoring. |
| Blueprint recommendations addressed | Outputs 1 Jan - 31 Dec 12 | Planned outputs 1 Jan – 30 Jun 13 |
|---|---|---|
|
Auditor-General's Report - Rec 1 - To achieve timely completion of key guidance material for complementary medicines,
|
Completed. Target dates for the completion of each key guidance document published. |
Continued provision of target dates and progress reports for the completion of each key guidance document. Finalisation of the revised Australian Regulatory Guidelines for Complementary Medicines. |
| 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 DoHA seeks to finalise work on the ‘coded indications’ project so as to limit the use of inappropriate claims and indications on the ARTG. |
Completion potentially delayed. Stakeholder consultation on Standard (coded) Indications commenced. Improvements to the Electronic Listing Facility (ELF) to implement Standard Indications changes. |
Completion potentially delayed. Finalisation of list of standard indications and proposal on how they would be used. RIS and legislative amendments drafted for introduction into Parliament in 2013, to enable elimination of the free text field and require sponsors to use only the available indications, or to apply for a new indication. However, consideration of the legislation may be delayed due to legislative timetables. |
| 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. |
Completed. Publication of a Compliance Review Framework on the TGA website. Regular publication on the TGA website of a list of listed complementary medicines cancelled during the previous 3 month period. |
Building on the work already completed, further updates to IT systems to deliver additional published reports in relation to listing compliance activities. Publication on the TGA website of further information on compliance reviews. Analysis of information from reviews to be used to develop risk profiles for compliance activity. |
|
Auditor-General's Report – Rec 4 - To improve compliance with the regulatory framework, the ANAO recommends that the TGA:
|
On track. Development of an IT reporting system for post-market reviews. |
On track. Analysis and development of risk profiles to better inform the selection of products for post-market reviews. |
| 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. |
Completed. 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. |
On track. Commence design of a workflow system for complaints, to facilitate reporting to the TGA Executive. Regular reporting on progress with investigations and trends in non-compliance developed and implemented. |
|
| Informal Working Group – Rec 1a - Provide increased information on product labels regarding regulatory assessment undertaken by TGA of complementary medicines. |
On track. Outcomes of work addressing Transparency Recommendation 7 will inform this work. Progress is dependent upon further consultation. |
|
| Informal Working Group – Rec 1b - Provide increased information on TGA website regarding regulatory assessment undertaken by TGA of complementary medicines. |
Completed. See comment on Auditor General's Report – Rec 3 above. |
|
|
Informal Working Group – Rec 2 - Modify Electronic Listing Facility system, to:
|
Completion potentially delayed. See comment on Auditor-General's Report - Rec 2 above. |
|
| Informal Working Group – Rec 3 - Update 'Guidelines for levels and kinds of evidence' and include 'Guidelines for levels and kinds of evidence' in regulation. |
Completion potentially delayed. Completion of stakeholder consultation on Evidence Requirements. |
Completion potentially delayed. Publication, in early 2013, of response to stakeholder consultation on the Evidence Requirements. Legislative amendments drafted for introduction into the Parliament in 2013. However, consideration of the legislation may be delayed due to legislative timetables. |
| 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. |
Completion potentially delayed. 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. AND 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. Commencement of stakeholder consultation on proposals for the future regulatory framework for the advertising of therapeutic products. Options arising from consultation and internal review endorsed by DoHA Secretary. |
Obtain policy approval for proposals for the future regulatory framework for the advertising of therapeutic products, including more effective approaches to sanctions and penalties. Development of a Regulation Impact Statement. |
| Blueprint recommendations addressed | Outputs 1 Jan - 31 Dec 12 | Planned outputs 1 Jan – 30 Jun 13 |
|---|---|---|
| Medical Device Reforms – Proposal 1 Reclassification of joint replacement implants. |
Completed. 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 continues until 30 June 2014. |
|
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. Proposal 3(i) - Amend the way in which a kind of medical device is included in the ARTG. Proposal 4 - Publication of device product information on the TGA Website. |
On track. Development of reform options for each recommendation based (in part) on initial 2010 consultation. |
On track. Stakeholder consultation will be undertaken on this suite of reforms. Policy approval to be sought from Government on proposed changes. |
| Blueprint recommendations addressed | Outputs 1 Jan - 31 Dec 12 | Planned outputs 1 Jan – 30 Jun 13 |
|---|---|---|
| Advertising Consultation - Rec 1 Publish the report on advertising reform on the website, once finalised. |
Completed. The Advertising Regulatory Framework - Options for Reform report published on the TGA website in May 2012. |
|
|
Advertising Consultation – Rec 2 - Reforms to advertising framework. 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). 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). Develop a more effective approach to sanctions and penalties (including use of the infringement notice provisions). |
On track. Commencement of stakeholder consultation on proposals for the future regulatory framework for the advertising of therapeutic products. Review of pre-approval business requirements and internal consultation on implementation of the pre-approval system. Development of a draft Functional Specification for the development of a new advertising workflow database. Options arising from consultation and internal review endorsed by DoHA Secretary. |
On track. Obtain policy approval for proposals for the future regulatory framework for the advertising of therapeutic products, including more effective approaches to sanctions and penalties. Development of a Regulation Impact Statement. |