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TGA external communication and education framework

Priorities and projects 2013-2015

21 December 2012

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Specific communication and education projects

The TGA is placing increased emphasis on:

  • listening to, educating, and communicating with consumers
  • developing clearer two-way communications with healthcare professionals and the regulated therapeutic goods industry
  • further coordination of communication and education activities with other government organisations and stakeholder bodies.

Consumers

The TGA will provide clear, consistent and relevant information aimed at building consumer awareness and understanding of the regulation of therapeutic goods and how this can help people to make informed decisions about medicines and medical devices.

This will be achieved through a variety of methods including:

  • developing new, targeted publications in online, print and multimedia formats
  • improving TGA websites, the management of phone enquiries and the information written by the TGA for consumers
  • increasing the number of ways to access TGA information, for example, by developing material for sharing via a broad spectrum of media, including social media
  • implementing new processes for obtaining and responding to feedback from consumers, for example feedback forms on TGA websites and undertaking market research
  • working with the NPS and other information providers to provide information to consumers that is consistent with the principles of the quality use of medicines.

Communication and education projects include:

  • adverse reactions - develop a publicly available database where consumers can search information on adverse reactions to medicines and medical devices
  • recalls - deliver a therapeutic goods recalls portal that enables consumers to find information about recalls, and publish all safety alerts and recall notices on the TGA website
  • safety issues - deliver a common early warning system to inform consumers of potential safety issues
  • risks - inform consumers that there are risks associated with all medicines and medical devices, and that they should treat complementary medicines and low risk devices with care
  • travelling with therapeutic goods - consumer friendly information to assist people when travelling
  • purchasing therapeutic goods from overseas, or via the Internet - expand the existing education program on associated risks for consumers
  • complaints about therapeutic goods - what the procedures are, the types of issues the TGA manages, and the issues that are outside its regulatory scope to help consumers know where to go to lodge a complaint
  • registered (AUST R) and listed (AUST L) therapeutic goods - the differences between them and the processes of evaluation so consumers have a better understanding of the products they use
  • herbal medicines and stethescopecomplementary medicines - explain that most are not required under legislation to be evaluated by the TGA for efficacy before being made available in Australia, so consumers have a better understanding of the products they use
  • post-market reviews of complementary medicines - provide information on outcomes of TGA reviews so consumers can see the results
  • advertising - monitoring and investigating advertising issues, the complaints process and how outcomes of complaints are communicated
  • enforcement - TGA powers and procedures, as well as outcomes of enforcement activities, to help consumers better understand the role and work of the TGA
  • nanoparticles in therapeutic goods - in particular, how the TGA regulates the quality, safety and efficacy of sunscreens
  • medical devices - the reform process to their regulation and the benefits and risks associated with different classes of medical devices. Increase understanding amongst consumers that a small proportion of medical devices will and do fail in use
  • food and medicines - how consumers can distinguish the two, and understand the different regulatory roles undertaken by the TGA, Food Standards Australia New Zealand (FSANZ), and the State and Territory Governments
  • generic medicines - information to help consumers understand what a generic medicine is and the process the TGA uses to evaluate generic medicines for registration
  • human cell and tissue therapy products - information to help consumers understand what human cell and tissue therapy products are and the process the TGA uses to evaluate them
  • therapeutic goods cancellations - once the system has been reviewed, provide an option for notifying consumers about therapeutic goods that have been cancelled and removed from the ARTG, and which can no longer be lawfully supplied in Australia

Photo of a medical practitioner talking to a patient about a bottle of medicineConsultation

Consultation activities targeting consumers will be undertaken, including on the following reforms:

  • proposed regulatory changes to the labelling and packaging of medicines
  • guidelines for levels and kinds of evidence for complementary medicines
  • options for maintaining the currency of Consumer Medicines Information (CMI) and approved Product Information (PI)
  • increasing pre-market scrutiny for implantable medical devices
  • the recommendations for advertising reform including a more effective approach to sanctions and penalties.

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Health professionals

The TGA will provide information to health professionals that can be easily received and shared. These communication and education projects will allow health professionals to give advice and make decisions about the safe use of therapeutic goods.

This will be achieved through a variety of methods including:

  • developing stronger relationships with universities, colleges and other health professional education providers
  • making extensive use of pharmacy, medical and mainstream media to publicise new regulations, warnings or safety alerts, and publish all hazard alert and recall notices on the TGA website
  • providing a system for notifying health professionals when certain new products are given marketing authorisation or taken off the market
  • increasing health professional awareness of, and participation in, the adverse event reporting system and continuing to work with stakeholders to improve sharing of information on vaccine adverse events
  • providing targeted information at selected healthcare conferences.

Photo of four smiling medical practitionersCommunication and education projects include:

  • the role of the TGA - information for health professionals on what and how we regulate and what we do not regulate, such as areas of professional practice
  • safety information - improve the system for health professionals to be notified about safety information, including recalls and safety alerts (in particular vaccines and implantable devices)
  • adverse events - develop a publicly available adverse events database that includes advanced searching options for health professionals, with information on adverse reactions to medicines and medical devices
  • therapeutic goods cancellations - once the system has been reviewed, provide an option for notifying health professionals about therapeutic goods that have been cancelled and removed from the ARTG, and thus can no longer be lawfully supplied in Australia
  • the Special Access Scheme - how the scheme operates and how health professionals can access unapproved therapeutic goods
  • statutory advisory committees - clarify the role of committees and how health professionals can express interest in becoming a member of a TGA advisory committee
  • medical devices - updates about the reform process on the regulation of medical devices to increase understanding of the meaning and importance of clinical evidence
  • TGA assessment processes - information on how the products health professionals prescribe or dispense are regulated by the TGA. This includes information on the risk management approach to carrying out a range of assessment and monitoring activities to ensure therapeutic goods available in Australia are of an acceptable standard, and manufactured in accordance with the principles of good manufacturing practice
  • human cell and tissue therapy products - how they are regulated under recently introduced changes for biological products, including information for health professionals on the classification and approval processes
  • Australia New Zealand Therapeutic Products Agency (ANZTPA) - outline changes to the regulatory frameworks for therapeutic products

Photo of a medical practitioner holding an ultrasound deviceConsultation

Consultation activities targeting health professionals will be undertaken on the following reforms:

  • consideration of processes that would help maintain the currency of Consumer Medicines Information (CMI) and approved Product Information (PI)
  • proposed options for regulatory changes to the labelling and packaging of medicines
  • harmonisation of current Australian ingredient naming with international non-proprietary names
  • proposed changes to regulation of extemporaneous compounded medicines
  • guidelines for levels and kinds of evidence for complementary medicines
  • proposals to increase premarket scrutiny for implantable medical devices
  • recommendations for advertising reform for therapeutic products
  • the ANZTPA common regulatory framework.

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Industry

The TGA will provide clearer information for the therapeutic goods industry to make it easier for them to meet regulatory requirements.

This will be achieved through:

  • improving how the TGA presents information on its regulatory processes for different therapeutic goods on the TGA website
  • better management of phone enquiries for industry
  • further improving the written information available to industry
  • providing more opportunities for industry to provide feedback about TGA information

Communication and education projects include:

  • regulatory guidance - ensuring that major regulatory guidance information is up to date, easy to find and user friendly so industry can better meet regulatory requirements
  • creating a timetable - providing a timetable for the conduct of consultations so industry can plan how to respond or change to meet potential new processes. This includes a timetable for the release of revised or new regulatory guidelines for comment.
  • international harmonisation - providing more information on TGA collaborative activities with other major therapeutic products regulators
  • advisory committees - publishing statements following committee meetings that summarise the matters considered so industry can respond to the feedback in future applications
  • advertising:
    • the restrictions placed on advertising therapeutic goods
    • what to do if these restrictions are not being upheld, including the TGA's role in terms of monitoring and investigating advertising issues
    • the complaints process and how outcomes of complaints are communicated
  • publishing outcomes of legal proceedings, investigation activities and compliance by industry with the Therapeutic Goods Act 1989
  • prescription medicines - implementation of changes to how the TGA allows sponsors to make minor variations to prescription medicines on the ARTG
  • generic medicines - provide clarity for industry on TGA's processes for evaluation and registration, and common deficiencies in data sets/applications
  • medical devices - the reform process being undertaken on regulation of medical devices
  • business process reviews - information for industry on existing reviews for over-the-counter medicine regulation, postmarket processes and manufacturing quality
  • Photo of a gloved hand manufacturing tabletsAustralian ingredient naming - to allow industry to have consistency with other international work on harmonisation of current names with international non-proprietary names
  • human cell and tissue therapy products - provide clarity for industry on how they are regulated under recently introduced changes for biologicals, including classification and approval processes
  • other therapeutic goods - provide clarity for industry on the requirements for and regulation of goods including sunscreens, sterilants and disinfectants
  • food and medicines - how they are distinguished in law, and where the division lies between the roles of the TGA, FSANZ and State and Territory Governments to enable sponsors to appropriately describe and regulate their products as therapeutic goods or foods
  • safety - working with industry to ensure that the systems for managing safety concerns are easy to use and transparent
  • complaints procedures - clarify for industry the types of issues that the TGA will manage, and the issues that are outside its regulatory scope
  • ANZTPA - provide updates on the progress of the project and outline changes to the regulatory and governance frameworks
  • TGA performance information - provide quantitative and qualitative information that is useful for industry on the TGA's organisational effectiveness and operational efficiency.

Consultation

Consultation activities targeted to industry will be undertaken on the following reforms:

  • business process reforms underway in relation to Over-the-Counter Medicines and Medical Devices Review
  • options for regulatory changes to the labelling and packaging of medicines
  • guidelines for levels and kinds of evidence for complementary medicines
  • processes and regulatory changes that would help maintain the currency of Consumer Medicines Information (CMI) and approved Product Information (PI)
  • the disclosure of commercially confidential information
  • potential medical devices reform options, including use of third party assessment bodies for Australian manufacturers; provision of device product names; recognition of third party assessment bodies and options for increasing premarket scrutiny for implantable medical devices
  • advertising reform including more effective approaches to sanctions and penalties
  • the ANZTPA common regulatory framework.

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