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TGA reforms: A blueprint for TGA's future: Progress report as at 31 December 2013
Expected benefits from the reforms
Over the last six months, the TGA has continued to improve its communication, education and stakeholder engagement activities through the implementation of the TGA external communication and education framework: Priorities and projects 2013-2015.
There has been a significant focus on the development of educational materials targeting specific audiences. In December 2013 we published and disseminated six information modules to educate final year university students on the work of the TGA. These modules have been provided in editable form so that can either be viewed in isolation, delivered by a lecturer as provided or particular slides incorporated into teaching materials by universities.
We have also developed new educational materials for consumers and health professionals on five topics: the role of the TGA; 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 how to become a commercial supplier of a therapeutic good. These were tested with target audiences in December 2013 and following some modifications will be released publicly in February 2014.
In addition to these projects, we have worked in partnership with other medicines and health information providers to create and disseminate information on a number of topics such as: the regulation of sunscreens containing nanoparticles, biosimilar medicines, adverse event reporting and medicine shortages.
We continued to participate in numerous public events and conferences in various capacities, ranging from providing speakers to purchasing exhibition space at conferences. Since July 2013, this has included exhibition spaces at events held by the Australian College of Nursing, the Pharmaceutical Society of Australia, the Australian Society of Anaesthetists and the Australian Students' Medical Association.
The TGA has also provided speakers to events held both domestically and internationally. This includes providing speakers at events organised by the Australian Self Medication Industry, New Zealand Self Medication Industry, Medical Technology Association of Australia, Medical Technology Association of New Zealand, the Public Health Association of Australia and the Complementary Healthcare Council. Presentations given at other events are available on our website.
Over the period we have also regularly engaged with many other stakeholders through formal meetings, including the Global Drug Safety Colloquium held in Brisbane and the Food Regulation Implementation Standing Committee in Perth. These opportunities enhance the ongoing stakeholder engagement that occurs through regular interactions and through our advisory and consultative committees.
Efforts to improve our website are ongoing. A major upgrade to the website occurred in November 2013; a new homepage was launched and the site was made more user friendly for people viewing it on devices and smartphones.
In July 2013 we incorporated the Australian Register of Therapeutic Goods (ARTG) into the website search engine. Users can now get results quickly and easily, and view the ARTG entries alongside all other information about the product/s without having to conduct the search separately through the eBusiness portal. (The eBS search functionality is still available.)
From August 2012 to July 2013 the TGA piloted a central unit, the Public Contact Team (PCT) to manage the flow of the TGA's main enquiry lines. This pilot was successful, and the PCT became an operational unit from July 2013. During 2013 we received 32,907 enquiries to the TGA's general 1800 number and generic email account, and through documenting the nature of these enquiries the PCT has made a significant contribution to identifying the needs of the TGA's stakeholders.
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 is an Australian National Audit Office Audit "Therapeutic Goods Regulation: Complementary Medicines" which reported in 2011. Major recommendations of that audit were:
- Timely completion of key guidance materials
- Improving the integrity of the listing system for complementary medicines so as to limit the use of inappropriate claims
- Achieving greater transparency regarding the post-market review of listed products
- Enhancing post-market monitoring so as to more efficiently focus post-market resources towards problem areas
- Developing more efficient processing of advertising complaints
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, is being finalised for publication. In addition, an update to the Australian Regulatory Guidelines for Complementary Medicines was made available in December 2013.
- Publishing outcomes of listing compliance reviews. The TGA will continue 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 reports 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, Public and industry consultations have been held to develop potential approaches for discussion with government.
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 from 1 July 2012 to 30 June 2014 for devices already in the ARTG. During this reporting period the assessment of reclassification applications has been a priority, with the TGA receiving applications to reclassify existing medical devices from late 2012. Communication with industry is ongoing to provide information on the ongoing transition and to ensure that the goals of the reform are achieved.
The Regulation 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. Options to enhance the premarket scrutiny of the highest risk devices are being further developed in consultation with stakeholders. The aim of reforms is to ensure appropriate regulatory scrutiny of devices to protect public health and safety while also reducing unnecessary administrative and regulatory burden and delays to market for industry and delays in access to new technologies for healthcare consumers. It is expected further consultation on these options will be undertaken in the first half of 2014.
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.
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-Only, Controlled Drug and certain Pharmacist -Only medicines is prohibited, and only price information can be provided in print materials.
A number of reviews, along with feedback from public consultations and media coverage over recent years have highlighted the dissatisfaction with the existing advertising regulatory framework for therapeutic goods. The major concern is that the framework is overly complicated, 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.
To address the above concerns, the TGA developed a set of proposals for reforming the advertising regulatory framework based upon the outcomes of the recent advertising reviews. These proposals were further refined in the Consultation Regulatory Impact Statement (RIS) - Regulating the advertising of therapeutic goods to the general public (31 May 2013) which closed on 19 July 2013.
The RIS proposed a number of reform options primarily focusing on the pre-approvals scheme, complaint handling procedures and sanctions and penalties for dealing with advertising breaches.
Over the last 6 months, the TGA has reviewed the submissions made in response to the Consultation RIS and submitted to Government options for improvements to the regulatory arrangements for the advertising of therapeutic goods to the general public.