TGA Focus and Wrap UpWhat we’ve done, and what we still need to do

Adj Proj John Skerritt

Deputy Secretary, Health Products Regulation Group

Australian Department of Health

Device Sponsor Information Day – 11 October 2017

Firstly, thanks for coming along today

• Very important to us that we properly communicate the regulatory

requirements for medical devices, and how you can best comply

• Today’s presentations have been about the current regulatory

framework …my presentation will look forward at some emerging

trends and the regulatory reforms that are underway

1

So….. But we don’t want…

2

This talk

Implementing the Review of Medicines and Medical Devices Regulation:

Priority review of certain novel devices

Australian Conformity Assessment Bodies

Greater use of international regulators’ assessments

Alignment with European regulatory requirements

Strengthening postmarket monitoring

Compliance and Enforcement

Review of “low risk” therapeutic goods (including devices)

Other reforms to the IVD framework

Where to next? – a regulatory scheme fit for the 21st century3

Overarching principles endorsed by Government

• Australia to maintain capacity to undertake assessments of

therapeutic goods for safety, quality and efficacy

• The Australian Government retain responsibility for approving

the inclusion of therapeutic goods in the ARTG

– Rather than automatically accepting international approvals

– However need to make much greater use of overseas evaluations

• Need to introduce greater flexibility in approval pathways for

both medicines and medical devices

• TGA could more appropriately align level regulation with the

actual risk posed by the products in certain areas

4

Seven sets of reforms

1. Increasing Flexibility for Registration and Post-Market Processes for Medicines

2. Increasing Flexibility for Approval and Enhanced Post-Market Monitoring of

Medical Devices

3. Increasing Flexibility for Pre-Market Approval and Increased Evidence of Efficacy

of Complementary Medicines for Consumers

4. Simplified and More Effective Regulation of Advertising of Therapeutic Products

5. Streamlined Regulation of Patient-Specific Access to Therapeutic Products

6. Further Reviews

7. Rationalisation of TGA Statutory Advisory Committees5

Changes for device regulation

• Introduction of multiple pathways:

– Conformity Assessment within Australia by TGA (current)

– Conformity Assessment within Australia by a body designated by TGA

– Utilisation of overseas marketing approval accepted in principle by Government

where the device has been:

Conformity Assessed by a body that has been designated by a comparable overseas

Designating Authority; or

Approved by a comparable overseas regulatory authority

• Expedited review process for certain novel devices

• Further alignment with European regulatory requirements6

Priority assessment of devices from Jan 2018

• Devices designated for Priority Assessment will be

allocated front-of-queue priority

• No reduction in evidence or assessment requirements

• Involves faster processing of conformity assessment

and/or ARTG inclusion

• Priority Review designation will lapse where

timeframes for submission of the application or requests

for information in assessment processes are not met

• There will be a fee for designation applications

additional to the current fees for inclusion or CA

7

Proposed criteria for priority designation

• Device intended for the treatment, prevention or treatment of a life

threatening or seriously debilitating disease or condition; AND

• Device addresses an unmet clinical need in Australian patients; AND

• Breakthrough technology/ clinical advantage/ public health (IVDs only)

• Meets at least one of the following:

– Device represents a major clinical (not just engineering) advantage over

existing technology; OR

– Device offers a major clinical (not just engineering) advantage over existing

alternatives included in the ARTG; OR

– For IVDs, early availability will result in a major public health benefit

8

Australian conformity assessment bodies – current state

• At present conformity assessment can either be from TGA

or from a EU Notified Body

• Independent commercial entities in Europe (Notified

Bodies) are authorised by individual governments there

– mandatory TGA audits for Class III / AIMD, some contraceptives,

disinfectants, intraocular devices and certain IVDs

– TGA can do audits for other devices if there are concerns

• TGA MUST do conformity assessment

– of devices containing medicines, animal, biological or microbial

tissues and of Class 4 IVDs

– sponsors can ask TGA to carry out conformity assessment of other

devices9

Australian conformity assessment bodies – proposed from

Jan 2018

• Government agreed to allow bodies designated by the TGA to be able to

undertake conformity assessment certification in Australia

• Public consultation from Nov 2016 to Jan 2017 outlined proposed details for:

– the TGA designating authority function

– designated conformity assessment bodies

– a designation process, including designation criteria

• To commence January 2018

• Changes included in first MMDR Bill (passed earlier this year), with further changes

in Bill currently before Parliament

• Regulations outlining the requirements also under development 10

Australian CA bodies – we will build it… but will they come?

Montreal Mirabel International Airport. Built for the 1976 Olympics.

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Australian conformity assessment bodies – costs?

• Fees charged to device manufacturers by conformity

assessment bodies will be determined by the CA bodies, not TGA

• TGA’s costs to designate Australian notified bodies still to be

finalised

• Impact on TGA conformity assessment fees also needs to be

clarified because of competitive neutrality

• Competitive neutrality aims to promote efficient competition

between public and private businesses, and to ensure that

government businesses do not enjoy advantages over private

sector competitors simply by virtue of public ownership

.

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Greater use of international regulators’ evaluations

• System is already built on use of EU notified bodies

But the EU system also undergoing significant change

• Potential for greater use of Canadian and US

evaluations

These frameworks are different to Australia

Applicant would need to provide the report

• Consulted on comparable overseas regulators (May to

June 2017)

– Required changes in the Bill before Parliament

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Alignment with Europe

• MMDR Recommendation 20 accepted by Government:

“The regulation of medical devices by the Australian NRA is, wherever possible,

aligned with the European Union framework…Should the Australian NRA seek to

apply specific requirements, there must be a clear rationale to do so.”

• Includes classification, essential principles/requirements, risk-based approach

• Consultation held so far on two specific aspects (July to August 2017):

– Up-classification of surgical mesh from Class IIb to Class III

– Requirement for patient information and patient card for implantable devices

• Consultations on harmonisation with other EU provisions will be undertaken in 2018

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Strengthening post-market monitoring

• Better integration and timely analysis of available

datasets (including matched de-identified patient

administrative data)

• Electronic reporting of adverse events

• Pharmacovigilance inspections of sponsors

• Public reporting of all laboratory testing results

• Enhanced information - sharing with overseas regulators

• Also, continued roll out of InSite Hospital program

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Compliance and enforcement

• The Review recommended that “TGA implement stronger

compliance and enforcement powers to protect the public, and

provide for graduated penalties that allow the TGA to respond

appropriately to the full range of non-compliant behaviors”

• Public consultation on these powers closed on 31 May 2017

• Proposed to bring TGA’s powers on monitoring, investigation,

infringement notices and injunctions, into line with other

Commonwealth regulators

• Proposed to remove the current requirement to prove harm or

likelihood of harm from strict liability offences in the Therapeutic

Goods Act but reduce the penalties for those offences16

Review of “low-risk” products

• Review of Class I medical devices to determine whether:

– they may be excluded from regulation by TGA or

– better regulated by TGA according to risk

• Several other products regulated as Other Therapeutic Goods

Listed or Registered (e.g. hard surface disinfectants)

• Consultation

– Over a thousand submissions received

– Development of policy proposals for Ministerial decision

17

IVD regulatory reforms

• Framework for regulation of In-house (laboratory-developed)

IVDs fully implemented from 1 July 2017

– NATA accreditation and compliance with NPAAC standard

on in-house IVDs for Class 1-3 in-house IVDs

– Notification to TGA

– Class 4 in-house IVDs to be included in ARTG

• Annual charges for IVDs effective from 1 July 2017

– Applied to postmarket monitoring e.g. 2016 comprehensive

assessment of home pregnancy tests performance

• Updating guidance on regulatory requirements for IVDs18

What else is on the horizon?

• Regulation of 3D printed devices

• Software as a medical device

• Risks of device hacking

• Companion diagnostics –

better alignment of assessments of

medicine and IVD components

19

Regulation of 3D printed devices

• 3D printing and personalised implants may fit the definition of a custom-made

device under the current therapeutic goods legislation

– Custom-made devices are exempt from inclusion in the ARTG

– Device typically must comply with the essential principles

– Australian manufacturer or sponsor must notify TGA

– They are required to report on adverse events

• How does regulation keep up with technological change?

– What evidence should a clinical trial for 3D printed device collect?

– How to manage innovations such as patient-matched 3D printed joint implants?

– TGA workshop held in Aug 2017 and we will soon consult publicly on options20

Software as a Medical Device – dilemmas

• Medical Apps: software is a medical device if it is

used for diagnosis, prevention, monitoring, treatment

or alleviation of disease... or is an accessory to a

medical device

– Apps that analyse clinical data, e.g. results of

blood tests or ECGs

– Embedded software in monitors, defibrillators,

pumps

and implantable devices

• Software that just presents or manages information

(e.g. medical records, dosage chart) is not a device21

Device vulnerability through hacking

An issue of real concern, especially with:

• newer cardiac devices such as pacemakers,

implantable cardioverter defibrillators, cardiac

resynchronisation devices

– some hacks can control the pace of the devices

– other hacks can drain the long life battery

• certain 3-D printed devices

– hacking could change the way the device is

printed, changing the shape, strength and

properties of the printed device

– also access to confidential patient information 22

More companion diagnostics coming?

• As of 2017 over 50% of global medicines industry revenue is from oncology

– Histology-based diagnosis and chemotherapy less important

– Greater use of bio-markers for determining target populations

• Drove much of the impetus for medicines priority review and provisional

approval pathways at TGA

– Will generate several priority reviews for related companion IVDs

• Aligning pathways of medicine and IVD product assessment

– Will be logistically complex

– Is a bespoke regulatory category needed to aligning regulatory requirements and

defining particular diagnostics as being “companion products”?23

A regulatory scheme for the 21st century

• Implementation of the MMDR is phased over 2017 to 2019

• TGA has been asked to work out the detail on how changes could be

implemented in consultation with stakeholders

• We are using TGA reserves to pay for cost of design of reforms, but there

will be new (negotiated) fees and charges associated with the new pathways

• Two major sets of changes to our legislation are needed while some other

reforms are to internal processes and development of new IT systems

• We need government policy approval for specific implementation options

• Need to implement review recommendations in parallel with business as

usual and implementing several other reforms24