{
  "entity_id": "B-002544",
  "folder": "Advisory-Committee-on-Vaccines",
  "name": "Advisory Committee on Vaccines",
  "type": "Statutory Body",
  "jurisdiction": "Commonwealth",
  "portfolio": "Health, Disability and Ageing",
  "website": "https://www.tga.gov.au/about-tga/advisory-bodies-and-committees/advisory-committee-vaccines-acv",
  "data_status": "partial",
  "completeness": {
    "has_strategy_brief": true,
    "has_strategy_structured": true,
    "has_vision": false,
    "has_kpi_targets": false,
    "has_kpi_results": false,
    "has_strategy_overview": true,
    "has_legislation_text": true,
    "has_legislation_structured": false,
    "has_global_initiatives_text": false,
    "has_global_initiatives_structured": false,
    "n_global_initiatives": 0,
    "has_ideas": true,
    "has_artifacts": true,
    "n_ideas": 12,
    "n_legislation": 0,
    "n_artifacts": 2,
    "n_kpi_targets": 0,
    "n_kpi_results": 0,
    "n_outcomes": 1,
    "verified_own_data": true
  },
  "strategy_profile": {
    "status": "needs_review",
    "confidence": "medium",
    "summary": "The Medical Devices Consumer Working Group (MDCWG) provides a forum for the Therapeutic Goods Administration (TGA) to work with consumer and patient groups to implement the TGA’s 2019 Action Plan for Medical Devices (Action Plan) and seek consumer perspectives on medical devices regulatory reforms.",
    "official_site_url": "https://www.tga.gov.au/about-tga/advisory-bodies-and-committees/advisory-committee-vaccines-acv",
    "source_documents": [],
    "purpose": {
      "text": "The Medical Devices Consumer Working Group (MDCWG) provides a forum for the Therapeutic Goods Administration (TGA) to work with consumer and patient groups to implement the TGA’s 2019 Action Plan for Medical Devices (Action Plan) and seek consumer perspectives on medical devices regulatory reforms.",
      "source_url": "https://www.tga.gov.au/sites/default/files/2024-05/medical-devices-consumer-working-group-terms-of-reference.pdf",
      "source_page": 4,
      "source_deep_url": "https://www.tga.gov.au/sites/default/files/2024-05/medical-devices-consumer-working-group-terms-of-reference.pdf#page=4"
    },
    "vision": null,
    "strategic_priorities": [],
    "values": [],
    "outcomes": [
      {
        "name": "Outcome 1: Patient-centred medical device regulations",
        "description": "The MDCWG ensures that medical device regulations and the reforms are patient-centred, and transparent, supporting the Action Plan in strengthening Australia’s regulatory system, to improve health outcomes for patients who require medical devices.",
        "activities": [
          "Consider and provide advice on proposed actions to improve medical devices regulatory transparency",
          "Discuss concerns affecting consumer groups to provide consumer viewpoints on medical devices and its regulation",
          "Assist the TGA with engaging with relevant stakeholders through their networks",
          "Progress activities recommended in agreed workplans"
        ],
        "source_url": "https://www.tga.gov.au/sites/default/files/2024-05/medical-devices-consumer-working-group-terms-of-reference.pdf",
        "source_page": 4,
        "source_deep_url": "https://www.tga.gov.au/sites/default/files/2024-05/medical-devices-consumer-working-group-terms-of-reference.pdf#page=4"
      }
    ],
    "performance_measures": [],
    "document_alignment_terms": {
      "must_support": [
        "The Medical Devices Consumer Working Group (MDCWG) provides a forum for the Therapeutic Goods Administration (TGA) to work with consumer and patient groups to implement the TGA’s 2"
      ],
      "watch_terms": [],
      "avoid_claiming_without_evidence": []
    },
    "review_note": "Structured strategy exists but is incomplete."
  },
  "global_initiatives": null,
  "strategy": {
    "reporting_period": "2024-25",
    "corporate_plan_period": "2025-26",
    "vision": null,
    "vision_source_page": null,
    "purposes": "The Medical Devices Consumer Working Group (MDCWG) provides a forum for the Therapeutic Goods Administration (TGA) to work with consumer and patient groups to implement the TGA’s 2019 Action Plan for Medical Devices (Action Plan) and seek consumer perspectives on medical devices regulatory reforms.",
    "purposes_source_page": 4,
    "how_we_deliver": null,
    "how_we_deliver_source_page": null,
    "government_priorities": [],
    "outcomes": [
      {
        "name": "Outcome 1: Patient-centred medical device regulations",
        "description": "The MDCWG ensures that medical device regulations and the reforms are patient-centred, and transparent, supporting the Action Plan in strengthening Australia’s regulatory system, to improve health outcomes for patients who require medical devices.",
        "key_activities": [
          "Consider and provide advice on proposed actions to improve medical devices regulatory transparency",
          "Discuss concerns affecting consumer groups to provide consumer viewpoints on medical devices and its regulation",
          "Assist the TGA with engaging with relevant stakeholders through their networks",
          "Progress activities recommended in agreed workplans"
        ],
        "source_page": 4
      }
    ],
    "values": [],
    "values_framework_name": null,
    "kpi_targets_2025_26": [],
    "kpi_results_2024_25": [],
    "_source_urls": {
      "annual_report_url": "",
      "corporate_plan_url": ""
    }
  },
  "ideas": [
    {
      "entity_id": "B-002544",
      "entity_name": "Advisory Committee on Vaccines",
      "folder_name": "Advisory-Committee-on-Vaccines",
      "category": "Regulation & Policy",
      "scale": "small",
      "title": "Regulatory burden scan for forms, guidance, and reporting",
      "idea": "Identify the top 10 highest-friction reporting obligations and simplify guidance, forms, or evidence requirements.",
      "quote": "TGA key performance indicators and measures: Regulator Performance Framework\n1 May 2015\nPage\nThe Regulator Performance Framework was developed to measure the performance of regulators and will apply from 1 July 2015.",
      "impact": "High",
      "effort": "Low",
      "proof": "Evidence-backed",
      "beneficiaries": "Regulated entities / policy teams",
      "source": "pages/corporate-plans-index.html (https://www.tga.gov.au/about-us/corporate-plans-and-reports)",
      "implementation": [
        "Pick one high-volume process or document family.",
        "Name an owner and baseline current volume, time, cost, and satisfaction.",
        "Run a 4-8 week pilot with clear before/after metrics.",
        "Publish lessons and decide whether to scale."
      ],
      "risks": [
        "Privacy and data quality",
        "Change fatigue",
        "Unclear accountability",
        "Regulatory capture",
        "Over-automation of judgement"
      ]
    },
    {
      "entity_id": "B-002544",
      "entity_name": "Advisory Committee on Vaccines",
      "folder_name": "Advisory-Committee-on-Vaccines",
      "category": "Regulation & Policy",
      "scale": "large",
      "title": "Adaptive regulation program with live feedback loops",
      "idea": "Create an adaptive regulation model using sandboxes, industry data, risk scoring, and regular rule updates.",
      "quote": "TGA key performance indicators and measures: Regulator Performance Framework\n1 May 2015\nPage\nThe Regulator Performance Framework was developed to measure the performance of regulators and will apply from 1 July 2015.",
      "impact": "Very High",
      "effort": "High",
      "proof": "Evidence-backed",
      "beneficiaries": "Regulated entities / policy teams",
      "source": "pages/corporate-plans-index.html (https://www.tga.gov.au/about-us/corporate-plans-and-reports)",
      "implementation": [
        "Create a senior responsible owner and cross-functional delivery team.",
        "Map legislation, data, privacy, procurement, cyber, and workforce constraints.",
        "Co-design with users and frontline staff before technology selection.",
        "Stage delivery through pilots, benefits tracking, and public reporting."
      ],
      "risks": [
        "Privacy and data quality",
        "Change fatigue",
        "Unclear accountability",
        "Regulatory capture",
        "Over-automation of judgement"
      ]
    },
    {
      "entity_id": "B-002544",
      "entity_name": "Advisory Committee on Vaccines",
      "folder_name": "Advisory-Committee-on-Vaccines",
      "category": "Risk & Assurance",
      "scale": "small",
      "title": "Recommendation tracker for audits, reviews, and inquiries",
      "idea": "Publish a single internal tracker for audit/review recommendations, owners, due dates, and implementation evidence.",
      "quote": "In addition to responding to high-risk allegations of non-compliance regarding these products we will:\nengage with industry regarding its regulatory obligations for the advertising of associated therapeutic goods\nprovide community education regarding the risks associated with the use of unapproved therapeutic goods as issues and trends emerge or are foreseen\ngather and use intelligence to identify higher-risk trends and products\ncontinue to use compliance projects to address these trends and products as identified\ncontinue to target advertising of unapproved products on digital platforms.",
      "impact": "High",
      "effort": "Low",
      "proof": "Evidence-backed",
      "beneficiaries": "Executives / assurance teams",
      "source": "pages/announcements-index__12.html (https://www.tga.gov.au/safety/compliance-and-enforcement/compliance-management-enforcement/import-advertising-and-supply-compliance-priorities-2023-25)",
      "implementation": [
        "Pick one high-volume process or document family.",
        "Name an owner and baseline current volume, time, cost, and satisfaction.",
        "Run a 4-8 week pilot with clear before/after metrics.",
        "Publish lessons and decide whether to scale."
      ],
      "risks": [
        "Privacy and data quality",
        "Change fatigue",
        "Unclear accountability",
        "Regulatory capture",
        "Over-automation of judgement"
      ]
    },
    {
      "entity_id": "B-002544",
      "entity_name": "Advisory Committee on Vaccines",
      "folder_name": "Advisory-Committee-on-Vaccines",
      "category": "Risk & Assurance",
      "scale": "large",
      "title": "Integrated assurance and lessons-learned system",
      "idea": "Create an assurance system that connects audit findings, risk registers, delivery reviews, and investment decisions.",
      "quote": "In addition to responding to high-risk allegations of non-compliance regarding these products we will:\nengage with industry regarding its regulatory obligations for the advertising of associated therapeutic goods\nprovide community education regarding the risks associated with the use of unapproved therapeutic goods as issues and trends emerge or are foreseen\ngather and use intelligence to identify higher-risk trends and products\ncontinue to use compliance projects to address these trends and products as identified\ncontinue to target advertising of unapproved products on digital platforms.",
      "impact": "Very High",
      "effort": "High",
      "proof": "Evidence-backed",
      "beneficiaries": "Executives / assurance teams",
      "source": "pages/announcements-index__12.html (https://www.tga.gov.au/safety/compliance-and-enforcement/compliance-management-enforcement/import-advertising-and-supply-compliance-priorities-2023-25)",
      "implementation": [
        "Create a senior responsible owner and cross-functional delivery team.",
        "Map legislation, data, privacy, procurement, cyber, and workforce constraints.",
        "Co-design with users and frontline staff before technology selection.",
        "Stage delivery through pilots, benefits tracking, and public reporting."
      ],
      "risks": [
        "Privacy and data quality",
        "Change fatigue",
        "Unclear accountability",
        "Regulatory capture",
        "Over-automation of judgement"
      ]
    },
    {
      "entity_id": "B-002544",
      "entity_name": "Advisory Committee on Vaccines",
      "folder_name": "Advisory-Committee-on-Vaccines",
      "category": "Data & Performance",
      "scale": "small",
      "title": "KPI evidence register with named owners",
      "idea": "Create a simple register mapping each KPI to source data, owner, frequency, target, and last result.",
      "quote": "TGA key performance indicators and measures: Regulator Performance Framework\n1 May 2015\nPage\nThe Regulator Performance Framework was developed to measure the performance of regulators and will apply from 1 July 2015.",
      "impact": "High",
      "effort": "Low",
      "proof": "Evidence-backed",
      "beneficiaries": "Executives / Parliament / public",
      "source": "pages/corporate-plans-index.html (https://www.tga.gov.au/about-us/corporate-plans-and-reports)",
      "implementation": [
        "Pick one high-volume process or document family.",
        "Name an owner and baseline current volume, time, cost, and satisfaction.",
        "Run a 4-8 week pilot with clear before/after metrics.",
        "Publish lessons and decide whether to scale."
      ],
      "risks": [
        "Privacy and data quality",
        "Change fatigue",
        "Unclear accountability"
      ]
    },
    {
      "entity_id": "B-002544",
      "entity_name": "Advisory Committee on Vaccines",
      "folder_name": "Advisory-Committee-on-Vaccines",
      "category": "Data & Performance",
      "scale": "large",
      "title": "Outcome dashboard linking budget, delivery, and public impact",
      "idea": "Build a public-facing outcome dashboard showing spend, outputs, outcomes, and delivery confidence.",
      "quote": "TGA key performance indicators and measures: Regulator Performance Framework\n1 May 2015\nPage\nThe Regulator Performance Framework was developed to measure the performance of regulators and will apply from 1 July 2015.",
      "impact": "Very High",
      "effort": "High",
      "proof": "Evidence-backed",
      "beneficiaries": "Executives / Parliament / public",
      "source": "pages/corporate-plans-index.html (https://www.tga.gov.au/about-us/corporate-plans-and-reports)",
      "implementation": [
        "Create a senior responsible owner and cross-functional delivery team.",
        "Map legislation, data, privacy, procurement, cyber, and workforce constraints.",
        "Co-design with users and frontline staff before technology selection.",
        "Stage delivery through pilots, benefits tracking, and public reporting."
      ],
      "risks": [
        "Privacy and data quality",
        "Change fatigue",
        "Unclear accountability"
      ]
    },
    {
      "entity_id": "B-002544",
      "entity_name": "Advisory Committee on Vaccines",
      "folder_name": "Advisory-Committee-on-Vaccines",
      "category": "Citizen Participation",
      "scale": "small",
      "title": "Consultation feedback summaries with response tracking",
      "idea": "Summarise consultation submissions by theme and publish what changed in response.",
      "quote": "ACM meeting statement, Meeting 55, 5 February 2026\n5 March 2026\nMeeting statements\nAdvisory Committee on Medicines meeting statement\nAll publications\nLatest consultations\nConsultation: Improvements to the regulation of sunscreens in Australia\n23 May 2026\nConsultation\nWe are seeking feedback on proposed changes to improve the regulation of therapeutic sunscreens in Australia.",
      "impact": "High",
      "effort": "Low",
      "proof": "Evidence-backed",
      "beneficiaries": "Citizens / stakeholders / policy teams",
      "source": "pages/news-latest.html (https://www.tga.gov.au/news)",
      "implementation": [
        "Pick one high-volume process or document family.",
        "Name an owner and baseline current volume, time, cost, and satisfaction.",
        "Run a 4-8 week pilot with clear before/after metrics.",
        "Publish lessons and decide whether to scale."
      ],
      "risks": [
        "Privacy and data quality",
        "Change fatigue",
        "Unclear accountability",
        "Digital exclusion",
        "Low public trust if feedback is not acted on"
      ]
    },
    {
      "entity_id": "B-002544",
      "entity_name": "Advisory Committee on Vaccines",
      "folder_name": "Advisory-Committee-on-Vaccines",
      "category": "Citizen Participation",
      "scale": "large",
      "title": "Always-on policy participation platform",
      "idea": "Create a standing participation platform where citizens and stakeholders can propose, vote, and track ideas.",
      "quote": "ACM meeting statement, Meeting 55, 5 February 2026\n5 March 2026\nMeeting statements\nAdvisory Committee on Medicines meeting statement\nAll publications\nLatest consultations\nConsultation: Improvements to the regulation of sunscreens in Australia\n23 May 2026\nConsultation\nWe are seeking feedback on proposed changes to improve the regulation of therapeutic sunscreens in Australia.",
      "impact": "Very High",
      "effort": "High",
      "proof": "Evidence-backed",
      "beneficiaries": "Citizens / stakeholders / policy teams",
      "source": "pages/news-latest.html (https://www.tga.gov.au/news)",
      "implementation": [
        "Create a senior responsible owner and cross-functional delivery team.",
        "Map legislation, data, privacy, procurement, cyber, and workforce constraints.",
        "Co-design with users and frontline staff before technology selection.",
        "Stage delivery through pilots, benefits tracking, and public reporting."
      ],
      "risks": [
        "Privacy and data quality",
        "Change fatigue",
        "Unclear accountability",
        "Digital exclusion",
        "Low public trust if feedback is not acted on"
      ]
    },
    {
      "entity_id": "B-002544",
      "entity_name": "Advisory Committee on Vaccines",
      "folder_name": "Advisory-Committee-on-Vaccines",
      "category": "Staff Productivity",
      "scale": "small",
      "title": "Reusable briefing and summary assistant for internal documents",
      "idea": "Create controlled templates for summarising reports, submissions, minutes, and ministerial briefs.",
      "quote": "The ACV considered this data in the context of the over 200,000 doses administered to females aged 15 to 49 years as reported to the Australian Immunisation Register.",
      "impact": "High",
      "effort": "Low",
      "proof": "Evidence-backed",
      "beneficiaries": "APS staff / executives",
      "source": "pages/announcements-index.html (https://www.tga.gov.au/resources/publication/meeting-statements/acv-meeting-statement-meeting-56-8-april-2026)",
      "implementation": [
        "Pick one high-volume process or document family.",
        "Name an owner and baseline current volume, time, cost, and satisfaction.",
        "Run a 4-8 week pilot with clear before/after metrics.",
        "Publish lessons and decide whether to scale."
      ],
      "risks": [
        "Privacy and data quality",
        "Change fatigue",
        "Unclear accountability",
        "Sensitive information leakage",
        "Inconsistent quality of generated drafts"
      ]
    },
    {
      "entity_id": "B-002544",
      "entity_name": "Advisory Committee on Vaccines",
      "folder_name": "Advisory-Committee-on-Vaccines",
      "category": "Staff Productivity",
      "scale": "large",
      "title": "Department-wide knowledge and briefing platform",
      "idea": "Build a secure knowledge platform that lets staff search, summarise, and cite approved departmental material.",
      "quote": "The ACV considered this data in the context of the over 200,000 doses administered to females aged 15 to 49 years as reported to the Australian Immunisation Register.",
      "impact": "Very High",
      "effort": "High",
      "proof": "Evidence-backed",
      "beneficiaries": "APS staff / executives",
      "source": "pages/announcements-index.html (https://www.tga.gov.au/resources/publication/meeting-statements/acv-meeting-statement-meeting-56-8-april-2026)",
      "implementation": [
        "Create a senior responsible owner and cross-functional delivery team.",
        "Map legislation, data, privacy, procurement, cyber, and workforce constraints.",
        "Co-design with users and frontline staff before technology selection.",
        "Stage delivery through pilots, benefits tracking, and public reporting."
      ],
      "risks": [
        "Privacy and data quality",
        "Change fatigue",
        "Unclear accountability",
        "Sensitive information leakage",
        "Inconsistent quality of generated drafts"
      ]
    },
    {
      "entity_id": "B-002544",
      "entity_name": "Advisory Committee on Vaccines",
      "folder_name": "Advisory-Committee-on-Vaccines",
      "category": "Case Processing",
      "scale": "small",
      "title": "Triage queue for stuck or ageing cases",
      "idea": "Use existing case data to flag ageing, duplicate, incomplete, or high-risk cases for earlier intervention.",
      "quote": "The working group continued discussions on the TGA risk assessment framework for breast implants, including how to enhance the framework’s adaptability to include a broader spectrum of topics on breast implant-related issues.",
      "impact": "High",
      "effort": "Low",
      "proof": "Evidence-backed",
      "beneficiaries": "Applicants / case officers",
      "source": "pages/taskforces-index__09.html (https://www.tga.gov.au/about-us/committees-and-advisory-bodies/breast-implant-expert-and-consumer-working-groups)",
      "implementation": [
        "Pick one high-volume process or document family.",
        "Name an owner and baseline current volume, time, cost, and satisfaction.",
        "Run a 4-8 week pilot with clear before/after metrics.",
        "Publish lessons and decide whether to scale."
      ],
      "risks": [
        "Privacy and data quality",
        "Change fatigue",
        "Unclear accountability"
      ]
    },
    {
      "entity_id": "B-002544",
      "entity_name": "Advisory Committee on Vaccines",
      "folder_name": "Advisory-Committee-on-Vaccines",
      "category": "Case Processing",
      "scale": "large",
      "title": "End-to-end case processing redesign",
      "idea": "Redesign the case pathway around risk-based triage, reusable evidence, and automated eligibility checks.",
      "quote": "The working group continued discussions on the TGA risk assessment framework for breast implants, including how to enhance the framework’s adaptability to include a broader spectrum of topics on breast implant-related issues.",
      "impact": "Very High",
      "effort": "High",
      "proof": "Evidence-backed",
      "beneficiaries": "Applicants / case officers",
      "source": "pages/taskforces-index__09.html (https://www.tga.gov.au/about-us/committees-and-advisory-bodies/breast-implant-expert-and-consumer-working-groups)",
      "implementation": [
        "Create a senior responsible owner and cross-functional delivery team.",
        "Map legislation, data, privacy, procurement, cyber, and workforce constraints.",
        "Co-design with users and frontline staff before technology selection.",
        "Stage delivery through pilots, benefits tracking, and public reporting."
      ],
      "risks": [
        "Privacy and data quality",
        "Change fatigue",
        "Unclear accountability"
      ]
    }
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      "year": "2024",
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      "year": "2023",
      "url": "https://www.tga.gov.au/sites/default/files/2023-05/patient-information-materials-for-medical-implants-a-fact-sheet-for-consumers.PDF",
      "file": "other-pdfs/patient-information-materials-for-medical-implants-a-fact-sheet-for-consumers.pdf",
      "bytes": 1646717,
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