Presentation on the role of the TGA by Professor John Skerritt at the Sponsor Information and Training Day

2. Plenary
The Role of the TGA
John Skerritt
National Manager
Sponsor Information and Training Day - 9 September 2014

3. Outline
• Structure of the TGA
• Key Facts and Figures
• Business improvement initiatives
• International Medical Device Regulators Forum
• Medical Device Single Audit Program
• Monitoring performance and safety after approval
• Confidence building
• Device regulation – still evolving
Sponsor Information and Training Day - 9 September 2014

4. TGA’s role – part of the Department of Health
• Regulates therapeutic goods including prescription, over-
the-counter and complementary medicines, medical devices,
biologicals, blood and blood products
• Evaluates therapeutic goods before they are marketed and
monitors products once they are on the market
• Assesses the suitability of medicines and medical devices for
export
• Focuses on safety, efficacy and quality
• We do not make regulatory decisions based on cost or value
for money or make decisions about which devices receive
Government subsidy
Sponsor Information and Training Day - 9 September 2014

5. Sponsor Information and Training Day - 9 September 2014

6. Market Authorisation Group
• Makes decisions
whether to approve
market authorisation
of products through
ODA
• Device authorisation
may also involve
OMA and OSE if the
device include
medicines or cells
• market authorisation activities for prescription and
non-prescription medicines, together with the exports
function
Office of
Medicines
Authorisation
• market authorisation activities for
medical devices
Office of Devices
Authorisation
• market authorisation and listing compliance activities
for complementary medicines
Office of
Complementary
Medicines
• scientific capability in the areas of toxicology,
pharmaceutical chemistry and biological sciences,
including blood and tissues products
Office of
Scientific
Evaluation
• services to MAG in the coordination and
administration of HR, Finance, Information
Management and Projects
Group Support
Unit
Sponsor Information and Training Day - 9 September 2014

7. Monitoring and Compliance Group
• Responsible for
ongoing
monitoring of
products
• Regulate how
devices are
manufactured
• Laboratory
testing also
important
• oversees products to ensure they
maintain an appropriate quality, safety
and performance
• includes Advertising and Recalls
Office of Product
Review
•laboratory testing, QA and test development in
microbiology, immunobiology, molecular
biology, biochemistry, chemistry and
biomaterials and engineering
Office of
Laboratories and
Scientific Services
•responsible for ensuring manufacturers of
medicines and medical devices meet
appropriate standards of quality
Office of
Manufacturing
Quality
•HR and Finance as well as providing assistance
with FoI requests and Ministerial response
Group Support
Unit
Sponsor Information and Training Day - 9 September 2014

8. Office of Devices Authorisation – 53 FTE
• Conformity Assessment – reviews evidence of safety,
performance, benefits and risk – compliance with
Essential Principles
• Application and Verifications – decisions on device and
IVD inclusions in ARTG and conduct of regulatory reviews
• Clinical – adequacy of clinical data – premarket
assessment, re-certification, special access use and
clinical trial advice
• Management and Coordination – regulatory reform,
MDSAP and stakeholder relations and information
Sponsor Information and Training Day - 9 September 2014

9. Conformity Assessment Facts and Figures
Internal Business process redesign enabled us to increase numbers of
applications handled without increasing staff numbers, through:
• Dedicated coordinating assessors, triage of applications, move to electronic
files
• Review of internal Conformity Assessment processes, enhanced risk
management
• Will be described in more detail later today
Results
• 25% increase in CA applications since 2011/12
• 66% increase in CA closure rates since 2011/12 – from 171 to 284
• 130 applications on hand on 30/6/14 versus 190 one year earlier
• Average completion time decreased from 293 to 215 working days in
2013/14
Sponsor Information and Training Day - 9 September 2014

10. Applications for inclusion of devices in the ARTG
Medical Devices (non-IVD) IVDs
2012/13 2013/14 2012/13 2013/14
Received 6500 (3700) 6300 (3400) 550 640
Complete 5850 (3050) 6700 (3800) 520 610
* Values in brackets indicate applications that are assessed or audited and not
automatically included
Sponsor Information and Training Day - 9 September 2014

11. TGA-wide Business Improvement Program aims
sponsors and manufacturers can contribute to its development
• Easier engagement with TGA
– Continue to enable electronic submissions for device regulatory
processes
– Strengthened guidelines and supporting information for sponsors
and manufacturers to enhance their interactions with TGA
• Ensuring accurate and useful information available in real
time
– Centralised data repository – single source of data
– New client portal for sponsors and manufacturers – to check
application status, receive invoices, and respond to requests for
additional information
– Rollout of a client relationship management system within TGA
Sponsor Information and Training Day - 9 September 2014

12. International devices alignment
• International Medical Device Regulators Forum
(IMDRF)
• Third party GMP audits being institutionalised to
satisfy several countries under the Medical Devices
Single Audit Program
• Potential for utilisation of US FDA Premarket
Assessments for devices with new and novel
technology
• Confidence building in European Notified bodies
to reduce the number of mandatory application
audits
Sponsor Information and Training Day - 9 September 2014

13. • Established 2011 to build on the Global Harmonisation
Task Force
• Members: Australia, Brazil, China, EU, Japan, Canada,
Russia and the USA
• Affiliate members: WHO, APEC’s Life Sciences Innovation
Forum Regulatory Harmonization Steering Committee and
Asian Harmonization Working Party
Sponsor Information and Training Day - 9 September 2014

14. IMDRF program
• Review system for confidential exchange of information on
serious adverse events, to
– Better address potentially serious signal detections which have not yet
resulted in recalls
– Develop a rapid communication exchange mechanism and
harmonised format for serious recalls
• Implementation of Unique Device Identification system
– Define roadmap to implementing a globally harmonised approach to
uniform device identification system
– Framework for regulators to develop their own UDI systems
• Review of recognised standards for devices to increase
consistency
Sponsor Information and Training Day - 9 September 2014

15. Regulated product submission
• Beta testing of standard to make sure it meets business requirements
for electronic filing of device applications
• Common, modular table of contents for device applications
• Defining common data elements, structure and electronic format
standard to support device identification over product lifecycle
• Table of Contents divided into 7 different chapters:
– Chapter 1 – Regional Administrative
– Chapter 2 – Submission Context
– Chapter 3 – Non-Clinical Evidence
– Chapter 4 – Clinical Evidence
– Chapter 5 – Labelling and Promotional Material
– Chapter 6A – QMS Procedures
– Chapter 6B – QMS Device Specific Information
Sponsor Information and Training Day - 9 September 2014

16. • Definitions document finalised
and published
• Framework for Risk
Categorization to be finalised
to introduce foundational
approach
• Harmonised vocabulary and
considerations for
manufacturers, regulators, and
users to address unique
challenges with SaMD
Software as a (Standalone) Medical Device
Sponsor Information and Training Day - 9 September 2014

17. Medical Devices Single Audit Program
• Will allow a single regulatory audit of a medical devices
manufacturer
– Australia, Brazil, Canada and the USA are participating
– Japan, the European Commission and WHO are observers
• Modelled after Health Canada’s third party program but also
draws upon best practices and experience of participants
• Several Notified Bodies have agreed to participate and 2-3
audits already carried out
• Challenge is now to encourage manufacturer participation
• Currently in pilot stage and will run through till 2016
Sponsor Information and Training Day - 9 September 2014

18. Monitoring Performance and Safety after Approval –
even more important for devices than medicines
• Reporting of Adverse Events – many are not reported due to
a lack of clarity on what to report
• Is it device caused? Role of health professional and
procedure ?
• Signal detection can be difficult – range of types and
causes of events
• Sporadic reporting – limited active reporting, post-market
surveillance regimes usually not mandated
• Liaison and sponsor related issues – incentives/ training for
reporting ?
Sponsor Information and Training Day - 9 September 2014

19. Recall actions
• Taken to resolve a problem with a device when there are
issues or deficiencies in relation to safety, quality,
performance or presentation
• Three types of recall actions:
– Recall – e.g. due to possibility of microbial contamination of
device
– Recall for product correction – e.g. potential safety issue if
fluids came in contact with insulin infusion set connector
– Hazard alert – e.g. for humeral resurfacing arthroplasty device,
due to potential to break after being implanted
You can search for recall actions via the
System for Australian Recall Actions (SARA) database
Sponsor Information and Training Day - 9 September 2014

20. Today’s workshop is about explaining the
current regulatory system – but it is evolving
….and regulations are able to be updated !
One, such as the member
of a governmental
regulatory agency, that
ensures compliance with
laws, regulations, and
established rules
reg·u·la·tor (rgy-ltr)n
Sponsor Information and Training Day - 9 September 2014

21. Potential regulatory reforms current
being discussed with stakeholders
• Option of removing requirement for Australian
Conformity Assessment by local manufacturers (2013 RIS)
• Enabling scrutiny of highest risk devices through a range
of possible pathways
• Other options to reduce potential duplication in parts of
local Conformity Assessment
• Development of clinical assessment guidance documents
• Potential publication of information on devices
Sponsor Information and Training Day - 9 September 2014

22. Confidence building program with notified bodies
 Program of joint inspections of notified bodies with
European regulators being undertaken, but as Australia is
not part of the EU
‒ We have to be invited to take part – variable
enthusiasm in EU
‒ We have limited legal standing and are just an
“observer”
 Direct confidence building in notified bodies now
planned, also integrating where possible with MDSAP
program
 Must be ongoing to maintain confidence in individual
Notified Bodies
Sponsor Information and Training Day - 9 September 2014

23. Proposal - ‘Level 3’ audits to apply for the highest risk
(AIMD and Class III) devices where:
• The TGA has not already ‘built confidence’ with the particular
notified body that has certified the type of medical device in
question, OR
• There are concerns about the device, such as where the
technology is novel, or there have been significant safety issues
with similar devices, OR
• Where the applicant is seeking inclusion on the Prostheses List or
MBS and requests TGA to undertake the audit to avoid duplication
A Level 3 audit reviews the raw clinical data underpinning the
conformity assessment report, the Notified Body’s Design Examination
report and the manufacturer’s quality management system.
Sponsor Information and Training Day - 9 September 2014

24. Development of clinical assessment guidance
documents
• Purpose is to clarify approaches to assessment of clinical
evidence for TGA/PLAC, industry and health care professionals
• Evaluating what is in place in US, Canada and Europe but specific
guidance documents for Australia will be needed
• Working with ASERNIPS (Australian Safety and Efficacy Register of
New Interventional Procedures – Surgical) and Clinical Groups
• Need to consider
– duration of clinical experience with the product, validation of
endpoints
– whether ISO standards exist for the device group
– post market data duration, registries
– bench testing requirements, use of data from predicate devices
Sponsor Information and Training Day - 9 September 2014

25. Potential publication of information on devices
• Publication of information about TGA regulatory decisions
in an AusPAR-like document - only publish rejection decisions
where they relate to issues involving the medical device’s
safety or efficacy
• Implementation of electronic instructions for use to reduce
regulatory burden
• Implementation of the TGA Transparency Review
recommendation that TGA publish information on devices,
such as a picture of the device, instructions for use and
labelling
• These initiatives would be implemented after further
consultation with industry and healthcare professionals
Sponsor Information and Training Day - 9 September 2014

26. The next steps
• Further consultation required
on options
‒ the fee structures that would apply
‒ guidance on options for which particular devices
would be subject to audit vs confidence building
‒ appropriate transition arrangements
• Reforms would not be retrospectively applied to devices
already on the ARTG
• Confidence building program with EU being pursued in
the meantime
Sponsor Information and Training Day - 9 September 2014

27. Conclusion: many challenges, but....
• The pace of scientific and policy change is challenging
but exciting
• Critical for regulators to keep up with developments –
no longer just gatekeepers
• Strong and open dialogue with stakeholders is
essential
• International collaboration and worksharing will be
critical in working with a globalised industry
Sponsor Information and Training Day - 9 September 2014

28. Subscribe to the TGA
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stay up-to-date:
www.tga.gov.au
Receive information on:
• Regulatory guidance
• Proposed reforms
• Safety alerts
• Recall actions
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• Consultations
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Sponsor Information and Training Day - 9 September 2014

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