TGA Focus and Wrap Up What weve done, and what we still need to do - - PowerPoint PPT Presentation

TGA Focus and Wrap Up

What 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

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So….. But we don’t want…

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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 century

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Overarching principles endorsed by Government

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• 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

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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
• f 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 Committees

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Changes for device regulation

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• 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 requirements

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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

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Proposed criteria for priority designation

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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

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Australian conformity assessment bodies – current state

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At present conformity assessment can either be from TGA

• r 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

• f devices containing medicines, animal, biological or microbial

tissues and of Class 4 IVDs sponsors can ask TGA to carry out conformity assessment of other devices

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Australian conformity assessment bodies – proposed from Jan 2018

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• 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

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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 ?

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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

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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

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• 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 offences

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Review of “low-risk” products

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• 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

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IVD regulatory reforms

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Framework for regulation of In-house (laboratory-developed) IVDs fully implemented from 1 July 2017 NATA accreditation and compliance with NPAAC standard

• n 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 IVDs

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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

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Regulation of 3D printed devices

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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 options

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Software as a Medical Device – dilemmas

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

used for diagnosis, prevention, monitoring, treatment

• r 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 device

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Device vulnerability through hacking

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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 –

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• ther 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

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More companion diagnostics coming?

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• 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

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– 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” ?

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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 reforms

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