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Delivering reforms - Implementation plan for TGA Reforms: A blueprint for TGA's future

16 July 2012

Book pagination

Attachment B - The Blueprint implementation schedule

The table below outlines the phase in which each recommendation for which the TGA is responsible is expected to be completed.

Legend
TR=Transparency Review
A-G=Auditor-General Report on Complementary Medicines
Adv=Advertising Consultations
IWG= Informal Working Group on Complementary Medicines
MD=Medical Devices Reform Consultations
Phase 1 - January 2012 to June 2012
Better managing our communication

Establish capability
Plan and design
Build momentum
Progress all themes
Phase 2 – July 2012 to June 2013
Better managing our practice

Align regulatory processes
Consult stakeholders
Deliver core foundational recommendations
Phase 3 – July 2013 to December 2015
Mature and sustainable performance

Implement all recommendations
Upgrade business systems
Realise benefits
Monitoring and Evaluation
Recommendations Completed Recommendations Completed Recommendations Completed

STREAM 1 – GOVERNANCE & MANAGEMENT

Managing and governing projects to deliver an integrated program of reform

  • Planning
  • Resourcing
  • Governance
  • Program Management
  • Strategic Alignment
  • Governance
  • Program Management
  • Annual Reviews
  • Governance
  • Program Management
  • Annual Reviews

STREAM 2 – COMMUNICATION & STAKEHOLDER ENGAGEMENT

Projects that deliver on recommendations for better communications and stakeholder engagement

  • Australian Therapeutic Goods Advisory Council
  • Consultation principles
  • Communication strategy
  • Application processing review
  • Regulatory Risk Framework
  • Evaluate post-market risk communication scheme
  • Public access to adverse event data
  • Publicise compliance outcomes
TR1
TR2
TR3
TR7
TR8
TR11
TR13
TR15
TR18
TR20
IWG5
  • Improved guidelines
  • Improved communication of adverse events, alerts and recalls
  • CMI/PI updated
  • Consult and provide advice to government on sanctions
TR4
TR5
TR6
TR9
TR10
TR12
TR14
TR16
TR17
TR19
TR21
IWG6

STREAM 3 – ADVERTISING

Projects that deliver on recommendations for reform of Advertising

  • 'Options for Reform' Report released
Adv1
  • Consult and provide advice to government
Adv2
Adv2a
Adv2c
  • Single entry point for advertising complaints
Adv2b

STREAM 4 – COMPLEMENTARY MEDICINES

Projects that deliver on recommendations for reform of Complementary Medicines

  • Publication of key guidance documents
A-G1(a)
A-G1(b)
  • Improved guidelines and information
  • Post market compliance reforms
  • Procedures for investigating advertising breaches
A-G2
A-G3
A-G4(a)
A-G4(b)
A-G5(a)
A-G5(b)
IWG1(a)
IWG1(b)
IWG2(a)
IWG2(b)
IWG3
IWG4

STREAM 5 – MEDICAL DEVICES

Projects that deliver on recommendations for reform of Medical Devices

  • Reclassify joint replacement implants
MD1
  • Consult on improved device information
  • Consult and provide advice to government on proposals for increased pre-market scrutiny and third party assessment bodies
MD2A
MD2B
MD2C
  • Provide product name information
  • Production product information
MD3(i)
MD4

STREAM 6 – ORGANISATION CHANGE

Projects and activities that support reform and deliver sustainable outcomes, including engaging TGA staff to understand, support and adopt reform changes

  • Develop TGA staff engagement strategy
  • Establish organisational change capability
  • Implement organisational change and staff engagement strategy
  • Identify IT system requirements
  • Assess implications for regulatory framework and legislation
  • Embed organisational change
  • Progressively implement business systems upgrade
  • Progressively implement amendments to legislation
Key Milestones Implementation Plan Published Annual Review 1 Annual Review 2 Annual Review 3

Book pagination