Variations to registered medicines Further work to develop a better - PowerPoint PPT Presentation

Variations to registered medicines Further work to develop a better risk-based approach Jenny Burnett Director, Scientific Operations Management Section Scientific Evaluation Branch Medicines Regulation Division, TGA ARCS Annual Conference 2018 22 August 2018

Outline • Reforms to date – the new notification processes • Getting the most from your notification • Opportunities for further refinement – known issues • Continuous improvement … what next? 1 Variations to registered medicines – ARCS 2018

Staged approach Phase 1 : Notifications for low risk changes to medicines Launched July 2017 • Non-prescription medicines • Automated processing and approval Launched December 2017 • Prescription medicines • Electronic submission of data • Automated processing and approval • Additional notification codes for non-prescription medicines Variations to registered medicines – ARCS 2018

Benefits of phase 1 improvements Registered non-prescription medicines Prescription medicines Reduced approval time Reduced approval time 20 working days 45 working days 48 hours 48 hours Cost savings* Cost savings* $1620 $1680 $790 $790 *fees per application as at 1 July 2018 3 Variations to registered medicines – ARCS 2018

How to get the most out of your notifications Check that your variation meets all assurances • If you do not meet all conditions, the proposed change is not a notification Follow conditions in guidance document • Ensure correct data requirements are attached Avoid letting GMP clearances expire • Expired clearances cause manufacturer validation errors; have to be ‘ceased’ and re-entered with the new clearance ID ions to registered medicines – ARCS 2018 4 Variat

Using variation types • Splitting of requests results in – multiple fees – inefficiencies for TGA processing – complexities for sponsors – requests potentially not meeting requirements for notifications • Have TGA’s statutory requirements been met when considering the s23 application? • Is the relevant legislation still ‘fit for purpose’? 5 Variations to registered medicines – ARCS 2018

Using Agile methodology- an iterative approach Reform program Phase 1 Identification of notification • ‘ Easy win’ notifications codes o SAR codes only IT development project • Project team o 9D requests only • Product Owner: • Industry stakeholders Phase 2 o from project team • Evaluation areas: prescription, • Refinements o key liaison point non-prescription, biologicals • Complex notifications o decision-maker • Legal services • Framework • Subject Matter Experts • Administrative areas • IT developers (application processing, finance) • Business analyst • Scrum master 6 Variations to registered medicines – ARCS 2018

Scope for refinement • Issues with attachments – a small number of applications have had attachments not come through – Using an internal report to identify instances for follow up with applicants • Not all ‘variations’ are on the e-form • Need clearer guidance on variations that create a separate and distinct good • More granularity in variation codes 7 Variations to registered medicines – ARCS 2018

Phase 2: Investigating further improvements Continuous improvement • Enhancements to notification processes and e-form • Extending electronic functionality Major reforms • Review of minor variations categorisation policy and cost-recovery framework 8 Variations to registered medicines – ARCS 2018

Investigating further improvements Paper-based e-forms Possible new notifications • Extension of Indications • Affecting Product Information (generic medicines) • Low risk ingredient changes • Additional trade names Requires Act change where variation can create a • Section 23 Self Assessable separate and distinct good Requests 9 Variations to registered medicines – ARCS 2018

Tipping point for a new approach When minor fixes aren’t sufficient • Lack of clarity when conditions for notifications/SARs aren’t met – which change type should be selected? • ‘Bundling’ of requests and ‘Splitting’ of evaluation processes leads to – increased admin burden – inappropriate fees – increased risk of fragmented decision making Extensive consultation and involvement of industry would be critical 10 Variations to registered medicines – ARCS 2018

Questions 11