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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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Expected benefits from the reforms

Communication and stakeholder engagement

Of the 34 projects outlined in the TGA external communications and education framework: Priorities and projects 2013-15, 28 have been completed and work on a further five has commenced, work on additional communication and stakeholder engagement projects is outlined in previous reports and in the text below.

Under the reform program, a number of projects were commenced or progressed in 2014 aimed at improving our business processes and reducing regulatory burden for industry.

Since September 2014, TGA educational information has been shown in 250 GP waiting rooms in all capital cities except Darwin, and these are being viewed each month by more than 850,000 people. The content is shown on the Medical Channel, a company that provides television screens and content in medical waiting rooms. 30 second clips about AUST L and AUST R numbers, how to travel with medicines and warnings about buying medicines and devices over the internet were shown and are also available on our TGA You Tube site.

Working in partnership with NPS MedicineWise, we released two online learning modules, Safety through reporting: online learning modules for health professionals, in December 2014. Health professionals are eligible for continuing professional development points after completing the modules.

In the second half of 2014, fourteen TGA speakers presented at the ARCS Scientific Congress and we also had exhibition space and supplied educational material to the delegates.

In response to the increasing number of enquiries our Public Contact Team is receiving from beauticians and beauty spa owners, we presented on advertising of therapeutic goods and shared exhibition space with the ACCC and NICNAS at the Sydney Spa and Beauty Expo. This event was attended by over 10,000 delegates.

In October we had exhibition space at the GP14 Conference and the Pharmaceutical Society of Australia National Congress.

Towards the end of 2014 TGA speakers presented at various conferences, including the AusBiotech National Conference, MedTech 2014, ASMI Conference, Complementary Medicines Australia National Conference, the Clinical Trial Summit organised by the Medical Oncology Group of Australia (MOGA), as well as the World Cancer Congress. Internationally, speakers presented at the WHO International Conference of Drug Regulatory Authorities (Brazil), the DIA Regulatory Conference (Japan) and the 4th International Workshop on Generic Drugs (China).

We have worked on a number of special projects throughout 2014 to make the TGA website more user-friendly for industry, health professionals and consumers. The Food-Medicine Interface Guidance Tool was built to help manufacturers and importers decide whether their product is regulated as a therapeutic good, and therefore which regulatory requirements apply. We have also created searchable databases providing information on products cancelled from the Australian Register of Therapeutic Goods (ARTG). We updated our online payment portal to make it easier to pay applications fees and allow users to pay without an invoice.

Over the second half of 2014 the entire public website, www.tga.gov.au, was migrated into a new content management system, called Drupal. This allows us to implement features such as more user friendly online forms, improved navigation and search. The mobile website was also upgraded, and with 30% of site traffic now coming from mobile devices we will continue to make sure this version of the website is easy to use and navigate.

The Public Contact Team continued to manage the flow of the TGA's main enquiry lines. From 1 July to 31 December 2014, they managed over 10,000 telephone enquiries and just under 4,000 written enquiries to the TGA's general 1800 number and generic email account. Through analysing the nature of these enquiries, the Public Contact Team has made a significant contribution to identifying the information needs of the TGA's stakeholders.

To get an assessment of the impact of our targeted education activities we used an independent market research company to conduct quantitative market research on awareness and perceptions of the TGA in November and December 2014. We used a similar methodology to the market research conducted in the first half of 2013. Industry, health professionals and consumers were surveyed about their levels of awareness of the therapeutic goods regulatory system, including the role and perceptions of the TGA.

The research found that the awareness of aspects of the regulatory system among health professionals has doubled since 2013. In 2013 and 2014 we targeted many of our educational activities to health professionals, this included having a TGA presence at certain health professional conferences and strongly promoting our email alerting services to this target audience. The consumer research showed that pharmacists and doctors are the most important sources of information about therapeutic goods for consumers. Results from the regulated industry surveys were largely unchanged; however, awareness of TGA consultation activities and of TGA expert advisory committees has significantly increased since 2013 with around three quarters aware of TGA consultations and over two thirds aware of TGA expert advisory committees. In 2013 and 2014 we ran awareness campaigns with industry about our consultation and committee activities.

In line with the TGA International Engagement Strategy, and as part of the Australian Government's agenda to further increase international regulatory cooperation efforts, we have continued our strong program of international stakeholder engagement.

During this period we have continued to explore opportunities to develop bilateral relationships with a number of our international counterparts. We have finalised a new collaborative arrangement with the Singapore Health Sciences Authority, and signed renewed Statements of Authority and Confidentiality Commitments with the United States Food and Drug Administration.

Complementary medicines

Improvements to complementary medicines regulation seek to improve community confidence in the safety and quality of these medicines and strengthen the integrity and transparency of the regulatory framework for complementary medicines. The driver for the reforms was an Australian National Audit Office Audit "Therapeutic Goods Regulation: Complementary Medicines" in 2011.

Whilst some recommendations involve more effective implementation of the existing regulatory framework, implementation of others would require changes to legislation and/or regulations.

  • Key regulatory guidance materials. Sponsors have always been required to hold evidence to support indications for their product. To assist, the Evidence Guidelines document provides sponsors with information on regulatory requirements and guidance on the evidence they are required to hold to support indications made for listed complementary medicines. A replacement version of the existing Evidence Guidelines, providing clearer assistance for sponsors, was published in March 2014. An update to the Australian Regulatory Guidelines for Complementary Medicines was made available in December 2013. Updates continued to be made throughout 2014 to ensure currency of the information.
  • Improving the integrity of the listing system for complementary medicines so as to limit the use of inappropriate claims. The TGA continues to work 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. Additional indications were added in December 2014.
  • Publishing outcomes of listing compliance reviews. The TGA continues to make information available in a timely manner to the Australian public, on cancellations of listed complementary medicines following post-market review.
  • Enhancing post-market monitoring. To improve compliance with the regulatory framework, the TGA will use information from compliance reviews to develop risk profiles of sponsors and characteristics of medicines to inform the targeted compliance review program.
  • Investigation processes for advertising breaches. The TGA has a standard procedure for investigations of advertising breaches in place. Regular reporting on progress with investigations and trends in non-compliance is being developed and implemented.

An area of potential change to the regulatory framework is improvements to the integrity of the listing system for complementary medicines through use of permitted indications and removal of "free text" in the listing. Implementation of this would be dependent on a policy decision by government and require legislative/ regulatory change. Potential reform of the regulation of permitted indications will be considered in the broader context of the Government's deregulatory agenda and the Expert Review of Medicines and Medical Devices Regulation.

Medical devices

This set of regulatory reforms seeks to improve community confidence in the safety and quality of medical devices and strengthen the integrity and transparency of the device regulatory framework to ensure that devices available to the public are of acceptable quality and safety, and perform as intended.

Hip, knee and shoulder joint implants (total and partial) were reclassified on 1 July 2012 from Class IIb (medium-high risk medical devices) to Class III (high risk medical devices), increasing regulatory oversight to better assure the products' safety, quality and performance. Regulatory change to the Therapeutic Goods (Medical Devices) Regulations 2002 includes a transition period, recently extended to 30 June 2015, for devices already in the ARTG. The transition period was extended to enable the TGA to undertake further consultation with affected stakeholders to consider the range of medical devices affected by reclassification, as well as options around the supply of devices for revision surgeries, without affecting the continuity of supply of devices to patients. Communication with industry is ongoing to provide information on the ongoing transition and to ensure that the goals of the reform are achieved.

Recent changes were made to allow Australian medical device manufacturers to use conformity assessment certification from European notified bodies when making applications to the TGA, as was already the case for overseas manufacturers. Previously Australian medical device manufacturers were required to seek a conformity assessment certificate from the TGA if they want to supply their product in Australia. This new approach provides more flexibility for Australian medical device manufacturers and in many cases should remove regulatory duplication and enable products to be available more quickly. Approval for this change was granted as part of the Government's Industry Innovation and Competitiveness Agenda, and the amendments to the Therapeutic Goods (Medical Devices) Regulations 2002 came into effect on 5 November 2014.

For a number of years the TGA has been consulting with stakeholders on reforms to increase premarket scrutiny of high risk medical devices. The Expert Review of Medicines and Medical Devices Regulation will examine options for future change to the medical device regulatory framework. Options for amending the way a kind of medical device is included in the ARTG to improve identification and traceability have been overtaken by development of an international system of Unique Device Identifiers (UDIs). This new global approach is to be rolled out by the US Food and Drug Administration over the next seven years, with corresponding UDI provisions under development in Europe. In providing unique identifiers for medical devices this system will improve device traceability as well as providing for better identification of devices by health care professionals and consumers. As the UDI system is being rolled out internationally, there is scope for Australia to harmonise and gain the advantages and efficiencies of this approach, avoiding the duplication and cost of implementing separate product identification measures.

Advertising of therapeutic products to the general public

The advertising of therapeutic goods to the public and health professionals is currently controlled by a combination of statutory measures administered by the TGA and self-regulation through Codes of Practice administered by the relevant industry associations. Advertising to the general public is permitted for the majority of therapeutic goods available for sale, while advertising of Prescription and certain Pharmacist-Only medicines is prohibited. A number of reviews, along with feedback from public consultations and media coverage over recent years have highlighted stakeholder dissatisfaction with the existing advertising regulatory framework for therapeutic goods. The major concern is that the framework is overly complicated, inconsistent, ineffective and inefficient, lacks transparency, and is difficult and costly to administer. In addition, there has been consistent feedback from consumer groups, supported by some media reports that resolution of advertising complaints is too slow.

TGA developed a set of proposals for reforming the advertising regulatory framework in the Consultation Regulatory Impact Statement (RIS) - Regulating the advertising of therapeutic goods to the general public in 2013.

The consultation RIS proposed a number of options primarily focusing on reforming pre-approvals scheme, improving the efficiency of the complaint handling process and aligning sanctions and penalties for dealing with advertising breaches with other comparable provisions within the legislation.

Further consideration of possible regulatory changes will be considered by Government as part of the response to the recommendations of the Expert Review of Medicines and Medical Devices Regulation.

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