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?

Variations to registered medicines – ARCS 2018 1

Staged approach

Phase 1: Notifications for low risk changes to medicines

• Non-prescription medicines
• Automated processing and approval
• Prescription medicines
• Electronic submission of data
• Automated processing and approval
• Additional notification codes for non-prescription medicines

Launched July 2017 Launched December 2017

Variations to registered medicines – ARCS 2018

Benefits of phase 1 improvements

Registered non-prescription medicines

Reduced approval time 20 working days 48 hours Cost savings* $1620 $790

Prescription medicines

Reduced approval time 45 working days 48 hours Cost savings* $1680 $790

*fees per application as at 1 July 2018 Variations to registered medicines – ARCS 2018 3

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

Variat

ions to registered medicines – ARCS 2018

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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’?

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Using Agile methodology- an iterative approach

Reform program Phase 1

• ‘Easy win’ notifications
• SAR codes only
• 9D requests only

Phase 2

• Refinements
• Complex notifications
• Framework

Identification of notification

codes

• Project team
• Industry stakeholders
• Evaluation areas: prescription,

non-prescription, biologicals

• Legal services
• Administrative areas

(application processing, finance)

IT development project

• Product Owner:
• from project team
• key liaison point
• decision-maker
• Subject Matter Experts
• IT developers
• Business analyst
• Scrum master

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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

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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

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Investigating further improvements

Possible new notifications

• Affecting Product Information
• Low risk ingredient changes

Requires Act change where variation can create a separate and distinct good

Paper-based e-forms

• Extension of Indications

(generic medicines)

• Additional trade names
• Section 23 Self Assessable

Requests

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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

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Questions

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