Spotlight on Medical Device MMDR Reforms Dr Cheryl McRae Assistant - PowerPoint PPT Presentation

Spotlight on Medical Device MMDR Reforms Dr Cheryl McRae Assistant Secretary Medical Devices Branch, TGA 2017 ARCS Annual Conference August, 2017

Expert Panel Review (MMDR) • Two reports released during 2015 – Medicines and Devices – Complementary medicines and Advertising • Review included discussion papers, submissions and interviews, followed by stakeholder workshops and other meetings • Department considered feedback and advised Minister, who took preferred position to Cabinet • Government intent released in May 2016 budget - full response released on 15 September 2016 – Government accepted 56 of the 58 Recommendations 1 Spotlight on Medical Device MMDR Reforms

Overarching principles for regulation As endorsed by Government • The Australian Government retains 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 • TGA could more appropriately align level of regulation with the actual risk posed by the products in certain areas 2 Spotlight on Medical Device MMDR Reforms

MMDR medical device projects • Key projects • Designation of conformity assessment bodies in Australia • Expedited review process for certain ‘novel’ devices • Use of approvals from comparable overseas regulators • Harmonisation with the European Union • Strengthening of post market monitoring Spotlight on Medical Device MMDR Reforms 3

MMDR medical device projects Other relevant projects • Further reviews - including review of the range of low-risk devices included in the ARTG • TGA advisory committees – includes new Advisory Committee on Medical Devices Related projects • Simplified and more effective regulation of advertising • Streamlined regulation of Patient-Specific Access • SME regulatory assistance Spotlight on Medical Device MMDR Reforms 4

Designation of conformity assessment bodies Implementation scheduled for January 2018 • Legislative change in progress: – Therapeutic Goods Amendment (2016 Measures No 1) Act 2017) – Royal Assent 19 June 2017 – Further legislative change in a further Bill for passage in the Spring 2017 sittings – Regulations also required • Key processes being designed: – TGA as designating authority - Roles and responsibilities, composition, structure, cost recovery and competitive neutrality – Conformity assessment bodies - Roles and responsibilities, requirements and market potential – Designation process - Framework and criteria 5 Spotlight on Medical Device MMDR Reforms

Designation of conformity assessment bodies Implementation will be complex • Few commercial conformity assessment bodies currently exist in Australia. • Is the market big enough to justify setting up Australian notified bodies? • Cost and logistics for TGA in being a designating authority as well as a conformity assessment body. • Flow on impacts of competitive neutrality requirements for TGA conformity assessment. 6 Spotlight on Medical Device MMDR Reforms

Expedited review process - certain ‘novel’ devices Implementation scheduled for January 2018 • Legislation in place (regulations also required) • ‘Front of queue’ approach with normal assessment requirements – Must still comply with EPs, conformity assessment procedures, etc. – Compliance with Clinical Evidence Guidelines critical for fast assessment • Reason for accelerated assessment would be based on health outcomes: – prevents, diagnoses or treats a life threatening or seriously debilitating disease or condition – addresses an unmet clinical need – breakthrough technology 7 Spotlight on Medical Device MMDR Reforms

Expedited review process - certain ‘novel’ devices Implementation will be complex • Need to define strict criteria to warrant expedited evaluation – Will be similar, but not identical, to US FDA criteria  include devices that can ‘prevent diseases and conditions’  include ‘seriously debilitating ’ rather than ‘irreversibly debilitating ’ conditions • Designation process will be under 6 weeks – eligible sponsor must submit application within 3 months • Impacts on other assessments need to be managed • Rejection by a foreign regulator and failure to continue meeting eligibility criteria can result in loss of status 8 Spotlight on Medical Device MMDR Reforms

Comparable overseas regulators Implementation scheduled for January 2018 • Legislation and regulations required – Legislative change in MMDR Bill for passage in the Spring 2017 sittings • Consultation closed 30 June 2017 – Submissions being considered (17 received) • Proposed criteria: – Scope – Life cycle approach – Operational alignment – Communication and cooperation – IMDRF member – Expertise 9 Spotlight on Medical Device MMDR Reforms

Comparable overseas regulators Implementation will be complex • International device regulations different to Australia • Comparable overseas regulators will need to be identified • Regulations undergoing significant change in Europe • Sponsors need to provide submissions and evaluation reports to TGA 10 Spotlight on Medical Device MMDR Reforms

Harmonisation with Europe New European regulations came into effect from 25 May 2017 • 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.” • Consultation has recently commenced on two specific aspects (closes 25 August 2017) : – Up-classification of surgical mesh from Class IIb to Class III – Requirement for patient medical device ID cards (patient implant cards)  Aim to be in place by end of 2017 (with transition aligned with Europe) • Further consultations on harmonisation with Europe will be released in 2018 11 Spotlight on Medical Device MMDR Reforms

Post market monitoring recommendations Accepted by Government • Better integration and timely analysis of available datasets • Electronic reporting of adverse events • Enhanced information-sharing with overseas regulators Deferred • Implementation of registries for all high risk implantable devices 12 Spotlight on Medical Device MMDR Reforms

Post market monitoring Enhanced Post Market Monitoring and Analytics (EPMMA) • TGA has embarked on a project aimed at establishing enhanced post market monitoring and analytics – has already delivered enhanced analytics for medical devices • The next stages in the project will deliver: – electronic data interchange (EDI) for reporting of medical device incident reports – improved TGA adverse event report management systems (AEMS). 13 Spotlight on Medical Device MMDR Reforms

Post market monitoring Electronic Data Interchange (EDI) • Currently, details of adverse events and incidents are manually entered in an online TGA form (via the TGA’s Business Services portal). • EDI will enable sponsors (and other users) to submit the required information directly from their own information management / investigation systems. • Expected to be launched early 2018. 14 Spotlight on Medical Device MMDR Reforms

Low risk product review Consultation closed May 2017 – over 1000 submissions • Part of review includes Class I medical devices: – does not recommend changing the current Australian classification system for medical devices – no specific products have been singled out under this review • Proposed next steps – Systematic review of ARTG to identify non therapeutic goods – Engage with States and Territories Health department procurement branches – Update the Excluded Goods Order – Review the Class I medical device ARTG entry process 15 Spotlight on Medical Device MMDR Reforms

Questions? 16