{ "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_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." }, "strategy_brief_md": "# Advisory Committee on Vaccines — Strategy Brief\n\n**Reporting period**: 2024-25\n**Corporate plan in force**: 2025-26\n**Corporate Plan**: [2025-26](https://www.tga.gov.au/sites/default/files/2024-05/medical-devices-consumer-working-group-terms-of-reference.pdf)\n\n## Our purpose / purposes\n\n> 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. [[CP p.4](https://www.tga.gov.au/sites/default/files/2024-05/medical-devices-consumer-working-group-terms-of-reference.pdf#page=4)]\n\n## Outcomes\n\n### Outcome 1: Patient-centred medical device regulations\nThe 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. [[CP p.4](https://www.tga.gov.au/sites/default/files/2024-05/medical-devices-consumer-working-group-terms-of-reference.pdf#page=4)]\n\n**Key activities:**\n- Consider and provide advice on proposed actions to improve medical devices regulatory transparency\n- Discuss concerns affecting consumer groups to provide consumer viewpoints on medical devices and its regulation\n- Assist the TGA with engaging with relevant stakeholders through their networks\n- Progress activities recommended in agreed workplans", "strategy_overview_evidence_md": null, "internal_strategy_evidence_md": "# Advisory Committee on Vaccines - Strategy, Performance, and Operating Profile\n\n**Generated at**: 2026-05-09T22:18:32.781433+00:00\n**Entity ID**: B-002544\n**Entity type**: Statutory Body\n**Jurisdiction**: Commonwealth\n**Portfolio**: Health, Disability and Ageing\n**Website**: https://www.tga.gov.au/about-tga/advisory-bodies-and-committees/advisory-committee-vaccines-acv\n\n> Draft generated from scraped source material. Treat this as an evidence pack for editorial review, not a final judgement.\n\n## Source Coverage\n\n| Source type | Count |\n|---|---:|\n| other-pdfs | 2 |\n| pages | 21 |\n\n## Executive Readout\n\n### Purpose\n\n- [Page 3]\nTherapeutic Goods Administration\nContents\nPurpose _______________________________________4\nScope ______________________________________________________4\nTerms of Reference ______________________________4\nRole of Individual Working Group Members ________________________5\nMembership ____________________________________5\nMembership Structure ___________________________5\nConsumer Members _____________________________6\nProxy ______________________________________________________6\nResignation _________________________________________________6\nMeeting frequency ______________________________6\nSub-working groups ___________________________________________6\nRemuneration __________________________________7\nConflicts of Interest and Confidentiality _____________7\nSecretariat _____________________________________7\nMeeting Management ____________________________7\n Source: `other-pdfs/medical-devices-consumer-working-group-terms-of-reference.pdf (https://www.tga.gov.au/sites/default/files/2024-05/medical-devices-consumer-working-group-terms-of-reference.pdf)`\n- Terms of Reference\nFor more information about the purpose and structure of the Group, see the Terms of Reference which was updated in May 2024:\nMedical Devices Consumer Working Group: Terms of Reference\n[PDF, 324.51 KB]\nMedical Devices Consumer Working Group: Terms of Reference\n[DOCX, 375.08 KB]\nMembership\nArthritis Australia\nAustralian Patients Association\nCancer Council Australia\nConsumers Health Forum of Australia\nContinence Foundation of Australia\nDiabetes Australia\nFederation of Ethnic Communities’ Councils of Australia\nHaemochromatosis Australia\nHaemophilia Foundation Australia\nHealth Consumers NSW\nLimbs 4 Life\nLung Foundation Australia\nMulticultural Centre For Women's Health\nNational Aboriginal and Torres Strait Islander Ageing and Aged Care Council\nNational Older Persons Reference Group\nNational Seniors Australia\nOlder Persons Advocacy Network\nPain Australia\n Source: `pages/taskforces-index__03.html (https://www.tga.gov.au/about-us/committees-and-advisory-bodies/medical-devices-consumer-working-group-mdcwg)`\n- Its purpose is to:\ndiscuss issues relating to the regulation of women's health products as they relate to women's health\nprovide advice to the Minister on relevant issues\nsupport other evidence-based outcomes under the National Women’s Health Strategy 2020-30.\n Source: `pages/taskforces-index__08.html (https://www.tga.gov.au/about-us/committees-and-advisory-bodies/womens-health-products-working-group)`\n- Meeting dates\nACV 56\n8 April 2026\nACV 57\n3 June 2026\nACV 58\n5 August 2026\nACV 59\n30 September 2026\nACV 60\n2 December 2026\nContact us\nACV enquiries\nCommittee support enquiries\nEmail\nacv@health.gov.au\nCommittees@health.gov.au\nPostal Address\nAdvisory Committee on Vaccines\nTherapeutic Goods Administration\nPO Box 100\nWODEN ACT 2606\nAttn: Prescription Medicines Authorisation Branch, MDP 122\nCommittee Support Unit\nTherapeutic Goods Administration\nPO Box 100\nWODEN ACT 2606\nAttn: Regulatory Engagement Branch, MDP 122\nOutcomes\nACV meeting statement, meeting 56, 8 April 2026\n7 May 2026\nMeeting statements\nAdvisory Committee on Vaccines meeting statement 56\nACV meeting statement, meeting 55, 2 December 2025\n20 January 2026\nMeeting statements\nAdvisory Committee on Vaccines meeting statement 55\nACV meeting statement, meeting 54, 1 October 2025\n21 November 2025\nMeeting statements\n Source: `pages/homepage.html (https://www.tga.gov.au/about-tga/advisory-bodies-and-committees/advisory-committee-vaccines-acv)`\n\n### Role and Functions\n\n- [Page 3]\nTherapeutic Goods Administration\nContents\nPurpose _______________________________________4\nScope ______________________________________________________4\nTerms of Reference ______________________________4\nRole of Individual Working Group Members ________________________5\nMembership ____________________________________5\nMembership Structure ___________________________5\nConsumer Members _____________________________6\nProxy ______________________________________________________6\nResignation _________________________________________________6\nMeeting frequency ______________________________6\nSub-working groups ___________________________________________6\nRemuneration __________________________________7\nConflicts of Interest and Confidentiality _____________7\nSecretariat _____________________________________7\nMeeting Management ____________________________7\n Source: `other-pdfs/medical-devices-consumer-working-group-terms-of-reference.pdf (https://www.tga.gov.au/sites/default/files/2024-05/medical-devices-consumer-working-group-terms-of-reference.pdf)`\n- 2025\n2024\n2023\n2022\n2021\n2020\n2019\n2018\n2017\n2016\n2015\n2014\nOpen all\n|\nClose all\n2025\nMeeting 38, 19 November 2025\nTopics discussed included\nReview of Action item from previous meeting\nMQB Section and TIWGG member updates -\nRecent PIC/S Seminar in Hong Kong with presentations provided by TGA staff.\n Source: `pages/taskforces-index__05.html (https://www.tga.gov.au/about-us/committees-and-advisory-bodies/tga-industry-working-group-good-manufacturing-practice-gmp-tiwgg/tiwgg-meeting-summaries)`\n- [pages 5,6,7,8,9]\ncture\nChair: First Assistant Secretary, MDPQD\nResponsibilities:\n• Direct and facilitate the business and discussion of the working group\n• Monitor the progress in the Working Group activities and its workplan(s)\n• Preside over working group meetings, maintaining order and guiding the meeting through the\nagenda items\n• Certify that the meeting occurred, attendance and the duration of the meeting\n• Clarify the definitions of meeting, preparation time, travelling time, and the nature of ‘other\nworking group-related business’\n• Make recommendations on working group related expenses, and\n• Present reports and/or recommendations to the Minister for Health and Aged Care, or Department\nof Heath and Aged Care.\n Source: `other-pdfs/medical-devices-consumer-working-group-terms-of-reference.pdf (https://www.tga.gov.au/sites/default/files/2024-05/medical-devices-consumer-working-group-terms-of-reference.pdf)`\n- 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.\n Source: `pages/announcements-index.html (https://www.tga.gov.au/resources/publication/meeting-statements/acv-meeting-statement-meeting-56-8-april-2026)`\n- Import, Advertising and Supply Compliance Priorities 2023-25\nRead about our new priority areas for compliance activities relating to the import, advertising and supply requirements of the Therapeutic Goods Act 1989 from 2023 to 2025.\n 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)`\n- The table below sets out our priority areas for compliance activities relating to the import, advertising and supply requirements of the\nTherapeutic Goods Act 1989\nfrom 1 July 2024 to 30 June 2025.\n 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)`\n\n### Strategic Priorities\n\n- Import, Advertising and Supply Compliance Priorities 2023-25\nRead about our new priority areas for compliance activities relating to the import, advertising and supply requirements of the Therapeutic Goods Act 1989 from 2023 to 2025.\n 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)`\n- The table below sets out our priority areas for compliance activities relating to the import, advertising and supply requirements of the\nTherapeutic Goods Act 1989\nfrom 1 July 2024 to 30 June 2025.\n 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)`\n- Plans and frameworks\nOur business plans\n21 July 2025\nPage\nThe business plan provides an overview of our strategic priorities and activities.\n Source: `pages/corporate-plans-index.html (https://www.tga.gov.au/about-us/corporate-plans-and-reports)`\n- 2025\n2024\n2023\n2022\n2021\n2020\n2019\n2018\n2017\n2016\n2015\n2014\nOpen all\n|\nClose all\n2025\nMeeting 38, 19 November 2025\nTopics discussed included\nReview of Action item from previous meeting\nMQB Section and TIWGG member updates -\nRecent PIC/S Seminar in Hong Kong with presentations provided by TGA staff.\n Source: `pages/taskforces-index__05.html (https://www.tga.gov.au/about-us/committees-and-advisory-bodies/tga-industry-working-group-good-manufacturing-practice-gmp-tiwgg/tiwgg-meeting-summaries)`\n- We have extended our Import, Advertising and Supply Compliance Priorities from the 2023-24 period into 2024-25.\n 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)`\n- Import, Advertising and Supply Compliance Priorities 2023-25\nCompliance Priority\nFocus\nDetect, deter and disrupt the unlawful import, advertising and supply of nicotine vaping products.\n 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)`\n- 2024\nMeeting 35, 21 November 2024\nTopics discussed included -\nReview of Action items from previous meetings\nGMP Forum Wrap Up\nMQB Section and TIWGG member updates\nUpdate on new Working Groups\nNew Sterile Medicines Technical Working Group - newly formed as a result of upcoming adoption of PIC/S Version 17.\n Source: `pages/taskforces-index__05.html (https://www.tga.gov.au/about-us/committees-and-advisory-bodies/tga-industry-working-group-good-manufacturing-practice-gmp-tiwgg/tiwgg-meeting-summaries)`\n- Meeting 9, 16 March 2017\nTopics discussed included -\nthe review of the regulation of low risk therapeutic goods\nan update from the February 2017 PIC/S Committee of Officials Meeting\ncurrent and future updates to PIC/S Guide (including Annex 1 revision timelines)\nthe Licensing and Certification Guidance Document and various GMP Clearance Issues\na proposed plan for adoption of the PIC/S Guide\na proposal to host an inaugural GMP Annual Industry Forum\na proposal concerning E-signatures on GMP Licences and Certificates\nTIWGG also welcomed an informative presentation from MTP Connect (the MedTech and Pharma Growth Centre).\n Source: `pages/taskforces-index__05.html (https://www.tga.gov.au/about-us/committees-and-advisory-bodies/tga-industry-working-group-good-manufacturing-practice-gmp-tiwgg/tiwgg-meeting-summaries)`\n- [Page 3]\nTherapeutic Goods Administration\nContents\nPurpose _______________________________________4\nScope ______________________________________________________4\nTerms of Reference ______________________________4\nRole of Individual Working Group Members ________________________5\nMembership ____________________________________5\nMembership Structure ___________________________5\nConsumer Members _____________________________6\nProxy ______________________________________________________6\nResignation _________________________________________________6\nMeeting frequency ______________________________6\nSub-working groups ___________________________________________6\nRemuneration __________________________________7\nConflicts of Interest and Confidentiality _____________7\nSecretariat _____________________________________7\nMeeting Management ____________________________7\n Source: `other-pdfs/medical-devices-consumer-working-group-terms-of-reference.pdf (https://www.tga.gov.au/sites/default/files/2024-05/medical-devices-consumer-working-group-terms-of-reference.pdf)`\n- Latest Meeting statements\nACV meeting statement, meeting 56, 8 April 2026\n7 May 2026\nMeeting statements\nAdvisory Committee on Vaccines meeting statement 56\nAdvisory Committee on Medical Devices, Meeting 88\n14 April 2026\nMeeting statements\nThe 88th meeting of the Advisory Committee on Medical Devices (ACMD) was held on 11 December 2025.\n Source: `pages/announcements-index__13.html (https://www.tga.gov.au/resources/publication/meeting-statements)`\n\n## KPIs, Targets, and Where They Are At\n\n- 2024\nMeeting 35, 21 November 2024\nTopics discussed included -\nReview of Action items from previous meetings\nGMP Forum Wrap Up\nMQB Section and TIWGG member updates\nUpdate on new Working Groups\nNew Sterile Medicines Technical Working Group - newly formed as a result of upcoming adoption of PIC/S Version 17.\n Source: `pages/taskforces-index__05.html (https://www.tga.gov.au/about-us/committees-and-advisory-bodies/tga-industry-working-group-good-manufacturing-practice-gmp-tiwgg/tiwgg-meeting-summaries)`\n- 2025\n2024\n2023\n2022\n2021\n2020\n2019\n2018\n2017\n2016\n2015\n2014\nOpen all\n|\nClose all\n2025\nMeeting 38, 19 November 2025\nTopics discussed included\nReview of Action item from previous meeting\nMQB Section and TIWGG member updates -\nRecent PIC/S Seminar in Hong Kong with presentations provided by TGA staff.\n Source: `pages/taskforces-index__05.html (https://www.tga.gov.au/about-us/committees-and-advisory-bodies/tga-industry-working-group-good-manufacturing-practice-gmp-tiwgg/tiwgg-meeting-summaries)`\n- Import, Advertising and Supply Compliance Priorities 2023-25\nRead about our new priority areas for compliance activities relating to the import, advertising and supply requirements of the Therapeutic Goods Act 1989 from 2023 to 2025.\n 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)`\n- The table below sets out our priority areas for compliance activities relating to the import, advertising and supply requirements of the\nTherapeutic Goods Act 1989\nfrom 1 July 2024 to 30 June 2025.\n 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)`\n- 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.\n Source: `pages/corporate-plans-index.html (https://www.tga.gov.au/about-us/corporate-plans-and-reports)`\n- TIWGG work plan for 2022\nDiscussion regarding topics for future 2022 TIWGG meetings:\nContinued updates regarding return to onsite inspections\nAdoption and updates of PIC/S GMP - routine item\nOngoing education - topics and concerns from industry to assist in identification of target education materials and approaches\nEducation on the different mechanisms available to support clearance application\nSub working groups - review the status of sub working groups and scope of their activities.\n Source: `pages/taskforces-index__05.html (https://www.tga.gov.au/about-us/committees-and-advisory-bodies/tga-industry-working-group-good-manufacturing-practice-gmp-tiwgg/tiwgg-meeting-summaries)`\n- Meeting 9, 16 March 2017\nTopics discussed included -\nthe review of the regulation of low risk therapeutic goods\nan update from the February 2017 PIC/S Committee of Officials Meeting\ncurrent and future updates to PIC/S Guide (including Annex 1 revision timelines)\nthe Licensing and Certification Guidance Document and various GMP Clearance Issues\na proposed plan for adoption of the PIC/S Guide\na proposal to host an inaugural GMP Annual Industry Forum\na proposal concerning E-signatures on GMP Licences and Certificates\nTIWGG also welcomed an informative presentation from MTP Connect (the MedTech and Pharma Growth Centre).\n Source: `pages/taskforces-index__05.html (https://www.tga.gov.au/about-us/committees-and-advisory-bodies/tga-industry-working-group-good-manufacturing-practice-gmp-tiwgg/tiwgg-meeting-summaries)`\n- The patient information leaflets are required to be available to patients by 14 February 2020 as a result of regulatory action taken by the TGA.\n Source: `pages/taskforces-index__09.html (https://www.tga.gov.au/about-us/committees-and-advisory-bodies/breast-implant-expert-and-consumer-working-groups)`\n- [Page 3]\nTherapeutic Goods Administration\nContents\nPurpose _______________________________________4\nScope ______________________________________________________4\nTerms of Reference ______________________________4\nRole of Individual Working Group Members ________________________5\nMembership ____________________________________5\nMembership Structure ___________________________5\nConsumer Members _____________________________6\nProxy ______________________________________________________6\nResignation _________________________________________________6\nMeeting frequency ______________________________6\nSub-working groups ___________________________________________6\nRemuneration __________________________________7\nConflicts of Interest and Confidentiality _____________7\nSecretariat _____________________________________7\nMeeting Management ____________________________7\n Source: `other-pdfs/medical-devices-consumer-working-group-terms-of-reference.pdf (https://www.tga.gov.au/sites/default/files/2024-05/medical-devices-consumer-working-group-terms-of-reference.pdf)`\n- Latest Meeting statements\nACV meeting statement, meeting 56, 8 April 2026\n7 May 2026\nMeeting statements\nAdvisory Committee on Vaccines meeting statement 56\nAdvisory Committee on Medical Devices, Meeting 88\n14 April 2026\nMeeting statements\nThe 88th meeting of the Advisory Committee on Medical Devices (ACMD) was held on 11 December 2025.\n Source: `pages/announcements-index__13.html (https://www.tga.gov.au/resources/publication/meeting-statements)`\n- ACM meeting statement, Meeting 55, 5 February 2026\n5 March 2026\nMeeting statements\nAdvisory Committee on Medicines meeting statement\nACCM meeting statement, Meeting 38, 6 November 2025\n23 January 2026\nMeeting statements\nAdvisory Committee on Complementary Medicines meeting statement for 6 November 2025\nACV meeting statement, meeting 55, 2 December 2025\n20 January 2026\nMeeting statements\nAdvisory Committee on Vaccines meeting statement 55\nACM meeting statement, Meeting 54, 4-5 December 2025\n19 January 2026\nMeeting statements\nAdvisory Committee on Medicines meeting statement\nAuthorised Prescriber scheme for psychedelics targeted consultation meeting statement\n24 December 2025\nMeeting statements\nOverview of the meeting to discuss proposed changes to the Authorised Prescriber application process\nWomen’s Health Products Working Group, Meeting 11\n15 December 2025\nMeeting statements\n Source: `pages/announcements-index__13.html (https://www.tga.gov.au/resources/publication/meeting-statements)`\n- An Action Plan for Medical Devices\n4 April 2019\nCorporate reports\nThe Action Plan will further improve Australia’s medical device regulatory system and place patient safety first\nHealth Products Regulation Group: Regulatory Science Strategy, 2020-2025\n16 January 2020\nCorporate reports\nOur plan for how HPRG will maintain and build its regulatory science capability over the next 5 years\nReports\nPerformance reports\n19 March 2025\nCorporate reports\nDetailed statistical information on Therapeutic Goods Administration performance in pre- and post-market activities.\n Source: `pages/corporate-plans-index.html (https://www.tga.gov.au/about-us/corporate-plans-and-reports)`\n- Meeting dates\nACV 56\n8 April 2026\nACV 57\n3 June 2026\nACV 58\n5 August 2026\nACV 59\n30 September 2026\nACV 60\n2 December 2026\nContact us\nACV enquiries\nCommittee support enquiries\nEmail\nacv@health.gov.au\nCommittees@health.gov.au\nPostal Address\nAdvisory Committee on Vaccines\nTherapeutic Goods Administration\nPO Box 100\nWODEN ACT 2606\nAttn: Prescription Medicines Authorisation Branch, MDP 122\nCommittee Support Unit\nTherapeutic Goods Administration\nPO Box 100\nWODEN ACT 2606\nAttn: Regulatory Engagement Branch, MDP 122\nOutcomes\nACV meeting statement, meeting 56, 8 April 2026\n7 May 2026\nMeeting statements\nAdvisory Committee on Vaccines meeting statement 56\nACV meeting statement, meeting 55, 2 December 2025\n20 January 2026\nMeeting statements\nAdvisory Committee on Vaccines meeting statement 55\nACV meeting statement, meeting 54, 1 October 2025\n21 November 2025\nMeeting statements\n Source: `pages/homepage.html (https://www.tga.gov.au/about-tga/advisory-bodies-and-committees/advisory-committee-vaccines-acv)`\n- Key Promotional Products and an individual ordered to pay $2 million for the unlawful import and supply of COVID-19 rapid antigen tests\n1 May 2026\nMedia releases\nThe Federal Court of Australia has ordered Key Promotional Products Pty Ltd to pay $1,750,000 for the unlawful import and supply of over 240,000 COVID-19 detection rapid antigen test kits.\n Source: `pages/news-latest.html (https://www.tga.gov.au/news)`\n\n## Key Metrics\n\n| Values found | Evidence | Source |\n|---|---|---|\n| $2 million, $1,750,000 , 2 million | Key Promotional Products and an individual ordered to pay $2 million for the unlawful import and supply of COVID-19 rapid antigen tests\n1 May 2026\nMedia releases\nThe Federal Court of Australia has ordered Key Promotional Products Pty Ltd to pay $1,750,000 for the unlawful import and supply of over 240,000 COVID-19 detection rapid antigen test kits. | `pages/news-latest.html (https://www.tga.gov.au/news)` |\n| $79,200 | TGA issues infringement notices for alleged unlawful advertising of therapeutic goods involving prohibited representations\n28 April 2026\nMedia releases\nWe have issued 4 infringement notices totalling $79,200 to Switch Nutrition Pty Ltd (Switch Nutrition) for the alleged unlawful advertising of therapeutic goods. | `pages/news-latest.html (https://www.tga.gov.au/news)` |\n| $2 million, $1,750,000 , 2 million | Key Promotional Products and an individual ordered to pay $2 million for the unlawful import and supply of COVID-19 rapid antigen tests\n1 May 2026\nMedia releases\nThe Federal Court of Australia has ordered Key Promotional Products Pty Ltd to pay $1,750,000 for the unlawful import and supply of over 240,000 COVID-19 detection rapid antigen test kits. | `pages/news-latest.html (https://www.tga.gov.au/news)` |\n\n## Key Achievements\n\n- 2016\nMeeting 8, 17 November 2016\nTopics discussed included -\nvarious GMP Clearance Issues including the development of a new e-form and associated workflow\nthe consultation process for revisions to the PIC/S Guide\nthe GMP standard for medicinal cannabis\nthe likelihood of impact of the Medicines and Medical Devices Review (MMDR) reforms on MQB\ncurrent and future updates to the PIC/S Guide\nconsultation on the PIC/S gap analysis: Version 9 vs Version 13\nconsultation on an ISO Standard gap analysis - ISO14644:2015 (Part 1 and 2) Cleanrooms and associated controlled environments\nPIC/S Guidance on Data Integrity\nAustralian implications for European API inspection requirements\nTGA hosting of an API PIC/S Expert Circle Meeting\nstatus of the revised Uniform Recall Procedure for Therapeutic Goods\n Source: `pages/taskforces-index__05.html (https://www.tga.gov.au/about-us/committees-and-advisory-bodies/tga-industry-working-group-good-manufacturing-practice-gmp-tiwgg/tiwgg-meeting-summaries)`\n- 2025\n2024\n2023\n2022\n2021\n2020\n2019\n2018\n2017\n2016\n2015\n2014\nOpen all\n|\nClose all\n2025\nMeeting 38, 19 November 2025\nTopics discussed included\nReview of Action item from previous meeting\nMQB Section and TIWGG member updates -\nRecent PIC/S Seminar in Hong Kong with presentations provided by TGA staff.\n Source: `pages/taskforces-index__05.html (https://www.tga.gov.au/about-us/committees-and-advisory-bodies/tga-industry-working-group-good-manufacturing-practice-gmp-tiwgg/tiwgg-meeting-summaries)`\n- 2022\n25 November 2022\nOn 25 November 2022, we met with the VEWG and Philips as part of the TGA’s ongoing effort to support patients and healthcare professionals and to track the progress of Philips’ repair and replacement program.\n Source: `pages/taskforces-index__07.html (https://www.tga.gov.au/about-us/committees-and-advisory-bodies/ventilator-expert-working-group-vewg)`\n- 28 October 2022\nAt the meeting with VEWG, on 28 October 2022, Philips’ representatives provided an update on the progress of the repair and replacement program, stating that 82% of the registered devices had been remediated.\n Source: `pages/taskforces-index__07.html (https://www.tga.gov.au/about-us/committees-and-advisory-bodies/ventilator-expert-working-group-vewg)`\n- 29 April 2022\nOn 29 April 2022, we met with the VEWG and Philips to discuss progress with the repair and replacement program, noting that 52% of the devices registered for correction have been remediated.\n Source: `pages/taskforces-index__07.html (https://www.tga.gov.au/about-us/committees-and-advisory-bodies/ventilator-expert-working-group-vewg)`\n- [pages 5,6,7,8,9]\ncture\nChair: First Assistant Secretary, MDPQD\nResponsibilities:\n• Direct and facilitate the business and discussion of the working group\n• Monitor the progress in the Working Group activities and its workplan(s)\n• Preside over working group meetings, maintaining order and guiding the meeting through the\nagenda items\n• Certify that the meeting occurred, attendance and the duration of the meeting\n• Clarify the definitions of meeting, preparation time, travelling time, and the nature of ‘other\nworking group-related business’\n• Make recommendations on working group related expenses, and\n• Present reports and/or recommendations to the Minister for Health and Aged Care, or Department\nof Heath and Aged Care.\n Source: `other-pdfs/medical-devices-consumer-working-group-terms-of-reference.pdf (https://www.tga.gov.au/sites/default/files/2024-05/medical-devices-consumer-working-group-terms-of-reference.pdf)`\n- Import, Advertising and Supply Compliance Priorities 2023-25\nRead about our new priority areas for compliance activities relating to the import, advertising and supply requirements of the Therapeutic Goods Act 1989 from 2023 to 2025.\n 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)`\n- The table below sets out our priority areas for compliance activities relating to the import, advertising and supply requirements of the\nTherapeutic Goods Act 1989\nfrom 1 July 2024 to 30 June 2025.\n 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)`\n- 2024\nMeeting 35, 21 November 2024\nTopics discussed included -\nReview of Action items from previous meetings\nGMP Forum Wrap Up\nMQB Section and TIWGG member updates\nUpdate on new Working Groups\nNew Sterile Medicines Technical Working Group - newly formed as a result of upcoming adoption of PIC/S Version 17.\n Source: `pages/taskforces-index__05.html (https://www.tga.gov.au/about-us/committees-and-advisory-bodies/tga-industry-working-group-good-manufacturing-practice-gmp-tiwgg/tiwgg-meeting-summaries)`\n- Meeting 9, 16 March 2017\nTopics discussed included -\nthe review of the regulation of low risk therapeutic goods\nan update from the February 2017 PIC/S Committee of Officials Meeting\ncurrent and future updates to PIC/S Guide (including Annex 1 revision timelines)\nthe Licensing and Certification Guidance Document and various GMP Clearance Issues\na proposed plan for adoption of the PIC/S Guide\na proposal to host an inaugural GMP Annual Industry Forum\na proposal concerning E-signatures on GMP Licences and Certificates\nTIWGG also welcomed an informative presentation from MTP Connect (the MedTech and Pharma Growth Centre).\n Source: `pages/taskforces-index__05.html (https://www.tga.gov.au/about-us/committees-and-advisory-bodies/tga-industry-working-group-good-manufacturing-practice-gmp-tiwgg/tiwgg-meeting-summaries)`\n- 3 February 2023\nOn 3 February 2023, we met with the VEWG and Philips as part of the TGA’s ongoing effort to support patients and healthcare professionals and to track the progress of Philips’ repair and replacement program.\n Source: `pages/taskforces-index__07.html (https://www.tga.gov.au/about-us/committees-and-advisory-bodies/ventilator-expert-working-group-vewg)`\n- 30 September 2022\nOn 30 September 2022, we met with the VEWG and Philips as part of the TGA’s ongoing effort to support patients and healthcare professionals and to track the progress of Philips’ repair and replacement program.\n Source: `pages/taskforces-index__07.html (https://www.tga.gov.au/about-us/committees-and-advisory-bodies/ventilator-expert-working-group-vewg)`\n\n## Key Issues, Risks, and Recommendations\n\n- Meeting 9, 16 March 2017\nTopics discussed included -\nthe review of the regulation of low risk therapeutic goods\nan update from the February 2017 PIC/S Committee of Officials Meeting\ncurrent and future updates to PIC/S Guide (including Annex 1 revision timelines)\nthe Licensing and Certification Guidance Document and various GMP Clearance Issues\na proposed plan for adoption of the PIC/S Guide\na proposal to host an inaugural GMP Annual Industry Forum\na proposal concerning E-signatures on GMP Licences and Certificates\nTIWGG also welcomed an informative presentation from MTP Connect (the MedTech and Pharma Growth Centre).\n Source: `pages/taskforces-index__05.html (https://www.tga.gov.au/about-us/committees-and-advisory-bodies/tga-industry-working-group-good-manufacturing-practice-gmp-tiwgg/tiwgg-meeting-summaries)`\n- 2016\nMeeting 8, 17 November 2016\nTopics discussed included -\nvarious GMP Clearance Issues including the development of a new e-form and associated workflow\nthe consultation process for revisions to the PIC/S Guide\nthe GMP standard for medicinal cannabis\nthe likelihood of impact of the Medicines and Medical Devices Review (MMDR) reforms on MQB\ncurrent and future updates to the PIC/S Guide\nconsultation on the PIC/S gap analysis: Version 9 vs Version 13\nconsultation on an ISO Standard gap analysis - ISO14644:2015 (Part 1 and 2) Cleanrooms and associated controlled environments\nPIC/S Guidance on Data Integrity\nAustralian implications for European API inspection requirements\nTGA hosting of an API PIC/S Expert Circle Meeting\nstatus of the revised Uniform Recall Procedure for Therapeutic Goods\n Source: `pages/taskforces-index__05.html (https://www.tga.gov.au/about-us/committees-and-advisory-bodies/tga-industry-working-group-good-manufacturing-practice-gmp-tiwgg/tiwgg-meeting-summaries)`\n- 2014\nMeeting 1, 16 December 2014\nTopics discussed included -\nthe government's consideration of its deregulation agenda\nthe Productivity Commission's report on reducing unnecessary regulatory burden on industry and a Regulator Performance Framework\nTIWGG's Terms of Reference and operating processes\nTIWGG's Technical Working Groups (TWGs)\nadoption of the PIC/S Guide to GMP for Medicinal Products (\"PIC/S Guide\")\nthe GMP Clearance application process\nthe PIC/S recommended model for risk based inspection planning in the GMP environment\nProduct types\nBiologicals\nMedicines\nUnapproved therapeutic goods\nBoundary and combination products\nTopics\nManufacturing\n Source: `pages/taskforces-index__05.html (https://www.tga.gov.au/about-us/committees-and-advisory-bodies/tga-industry-working-group-good-manufacturing-practice-gmp-tiwgg/tiwgg-meeting-summaries)`\n- In response to these issues, Philips has worked with the TGA to release two recall market notifications, these are covered under notices: RC-2023-RN-00209-1 and RC-2023-RN-00318-1.\n Source: `pages/taskforces-index__07.html (https://www.tga.gov.au/about-us/committees-and-advisory-bodies/ventilator-expert-working-group-vewg)`\n- 3 May 2022\nWe held a teleconference with the Breast Implant Expert Working Group on 3 May 2022 to discuss our updated clinical evidence guidelines on breast implants and tissue expanders and proposed updates to the TGA website and Breast Implant Hub, including data relating to the estimated risk of BIA-ALCL within Australia.\n Source: `pages/taskforces-index__09.html (https://www.tga.gov.au/about-us/committees-and-advisory-bodies/breast-implant-expert-and-consumer-working-groups)`\n- 15 August 2019\nWe held a teleconference with its breast implant expert working group on 15 August 2019 to facilitate input from consumer representatives and to table the identified risk and benefit factors for the breast implant devices available in Australia.\n Source: `pages/taskforces-index__09.html (https://www.tga.gov.au/about-us/committees-and-advisory-bodies/breast-implant-expert-and-consumer-working-groups)`\n- The potential risk of preterm birth was previously considered by the ACV at meeting 47 (31 January 2024) when advising on the optimal timing for the administration of ABRYSVO in pregnant women prior to registration.\n Source: `pages/announcements-index.html (https://www.tga.gov.au/resources/publication/meeting-statements/acv-meeting-statement-meeting-56-8-april-2026)`\n- 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.\n 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)`\n- TGA issues infringement notices for alleged unlawful advertising of therapeutic goods involving prohibited representations\n28 April 2026\nMedia releases\nWe have issued 4 infringement notices totalling $79,200 to Switch Nutrition Pty Ltd (Switch Nutrition) for the alleged unlawful advertising of therapeutic goods.\n Source: `pages/news-latest.html (https://www.tga.gov.au/news)`\n- 2025\n2024\n2023\n2022\n2021\n2020\n2019\n2018\n2017\n2016\n2015\n2014\nOpen all\n|\nClose all\n2025\nMeeting 38, 19 November 2025\nTopics discussed included\nReview of Action item from previous meeting\nMQB Section and TIWGG member updates -\nRecent PIC/S Seminar in Hong Kong with presentations provided by TGA staff.\n Source: `pages/taskforces-index__05.html (https://www.tga.gov.au/about-us/committees-and-advisory-bodies/tga-industry-working-group-good-manufacturing-practice-gmp-tiwgg/tiwgg-meeting-summaries)`\n- 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.\n Source: `pages/taskforces-index__09.html (https://www.tga.gov.au/about-us/committees-and-advisory-bodies/breast-implant-expert-and-consumer-working-groups)`\n- 23 March 2023\nWe held a teleconference with the Breast Implant Expert Working Group on 23 March 2023 to present an overview of updates to the TGA’s clinical evidence guidelines having considered the recommendations and advice previously provided by the working group in May 2022.\n Source: `pages/taskforces-index__09.html (https://www.tga.gov.au/about-us/committees-and-advisory-bodies/breast-implant-expert-and-consumer-working-groups)`\n- [pages 5,6,7,8,9]\ncture\nChair: First Assistant Secretary, MDPQD\nResponsibilities:\n• Direct and facilitate the business and discussion of the working group\n• Monitor the progress in the Working Group activities and its workplan(s)\n• Preside over working group meetings, maintaining order and guiding the meeting through the\nagenda items\n• Certify that the meeting occurred, attendance and the duration of the meeting\n• Clarify the definitions of meeting, preparation time, travelling time, and the nature of ‘other\nworking group-related business’\n• Make recommendations on working group related expenses, and\n• Present reports and/or recommendations to the Minister for Health and Aged Care, or Department\nof Heath and Aged Care.\n Source: `other-pdfs/medical-devices-consumer-working-group-terms-of-reference.pdf (https://www.tga.gov.au/sites/default/files/2024-05/medical-devices-consumer-working-group-terms-of-reference.pdf)`\n- Import, Advertising and Supply Compliance Priorities 2023-25\nRead about our new priority areas for compliance activities relating to the import, advertising and supply requirements of the Therapeutic Goods Act 1989 from 2023 to 2025.\n 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)`\n\n## Corporate Values and Operating Culture\n\n- Membership\nMembers of the WHPWG come from consumer, health professional and industry groups and academia:\nAustralian Clinical Trials Alliance\nAustralian College of Rural and Remote Medicine\nAustralian Nursing and Midwifery Federation\nAustralian Women’s Health Alliance\nBreast Cancer Network Australia\nConsumers Health Forum of Australia\nFederation of Ethnics Communities’ Councils of Australia\nJean Hailes for Women’s Health\nNational Aboriginal Community Controlled Health Organisation\nPharmaceutical Society of Australia\nThe Royal Australian College of General Practitioners\nThe Royal Australian and New Zealand College of Obstetricians and Gynaecologists\nRoyal Australasian College of Surgeons\nContact us\nCommittee Support Unit\nCollaboration Services Section\nRegulatory Education Branch\nEmail:\ncommittees@health.gov.au\nOutcomes\nWomen’s Health Products Working Group, Meeting 11\n15 December 2025\n Source: `pages/taskforces-index__08.html (https://www.tga.gov.au/about-us/committees-and-advisory-bodies/womens-health-products-working-group)`\n- Terms of Reference\nFor more information about the purpose and structure of the Group, see the Terms of Reference which was updated in May 2024:\nMedical Devices Consumer Working Group: Terms of Reference\n[PDF, 324.51 KB]\nMedical Devices Consumer Working Group: Terms of Reference\n[DOCX, 375.08 KB]\nMembership\nArthritis Australia\nAustralian Patients Association\nCancer Council Australia\nConsumers Health Forum of Australia\nContinence Foundation of Australia\nDiabetes Australia\nFederation of Ethnic Communities’ Councils of Australia\nHaemochromatosis Australia\nHaemophilia Foundation Australia\nHealth Consumers NSW\nLimbs 4 Life\nLung Foundation Australia\nMulticultural Centre For Women's Health\nNational Aboriginal and Torres Strait Islander Ageing and Aged Care Council\nNational Older Persons Reference Group\nNational Seniors Australia\nOlder Persons Advocacy Network\nPain Australia\n Source: `pages/taskforces-index__03.html (https://www.tga.gov.au/about-us/committees-and-advisory-bodies/medical-devices-consumer-working-group-mdcwg)`\n- 22 August 2025\nMeeting 16, 25 March 2025\nMeeting 15, 8 November 2024\nMeeting 14, 2 July 2024\nMeeting 13, 27 February 2024\nMeeting 12, 19 October 2023\nMeeting 11, 22 June 2023\nMeeting 10, 14 March 2023\nMeeting 9, 9 December 2022\nMeeting 8, 26 August 2022\nMeeting 7, 4 May 2022\nMeeting 6, 25 February 2022\nMeeting 5, 15 December 2021\nMeeting 4, 27 November 2021\nMeeting 3, 18 June 2020\nMeeting 2, 20 February 2020\nMeeting 1, 19 November 2019\nInitiatives\nThe Medical Devices Consumer Working Group has collaborated with us on consumer resources, including:\nTravelling with medicines and medical devices\nFive questions to ask your health professional before you get a medical implant\nPatient information materials for medical implants: a fact sheet for consumers\nThe Medical Devices Consumer Working Group has provided input to our hubs of information for:\nMedical devices reforms\nBreast implants\n Source: `pages/taskforces-index__03.html (https://www.tga.gov.au/about-us/committees-and-advisory-bodies/medical-devices-consumer-working-group-mdcwg)`\n- 2016\nMeeting 8, 17 November 2016\nTopics discussed included -\nvarious GMP Clearance Issues including the development of a new e-form and associated workflow\nthe consultation process for revisions to the PIC/S Guide\nthe GMP standard for medicinal cannabis\nthe likelihood of impact of the Medicines and Medical Devices Review (MMDR) reforms on MQB\ncurrent and future updates to the PIC/S Guide\nconsultation on the PIC/S gap analysis: Version 9 vs Version 13\nconsultation on an ISO Standard gap analysis - ISO14644:2015 (Part 1 and 2) Cleanrooms and associated controlled environments\nPIC/S Guidance on Data Integrity\nAustralian implications for European API inspection requirements\nTGA hosting of an API PIC/S Expert Circle Meeting\nstatus of the revised Uniform Recall Procedure for Therapeutic Goods\n Source: `pages/taskforces-index__05.html (https://www.tga.gov.au/about-us/committees-and-advisory-bodies/tga-industry-working-group-good-manufacturing-practice-gmp-tiwgg/tiwgg-meeting-summaries)`\n- 2025\n2024\n2023\n2022\n2021\n2020\n2019\n2018\n2017\n2016\n2015\n2014\nOpen all\n|\nClose all\n2025\nMeeting 38, 19 November 2025\nTopics discussed included\nReview of Action item from previous meeting\nMQB Section and TIWGG member updates -\nRecent PIC/S Seminar in Hong Kong with presentations provided by TGA staff.\n Source: `pages/taskforces-index__05.html (https://www.tga.gov.au/about-us/committees-and-advisory-bodies/tga-industry-working-group-good-manufacturing-practice-gmp-tiwgg/tiwgg-meeting-summaries)`\n- Import, Advertising and Supply Compliance Priorities 2023-25\nRead about our new priority areas for compliance activities relating to the import, advertising and supply requirements of the Therapeutic Goods Act 1989 from 2023 to 2025.\n 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)`\n- The table below sets out our priority areas for compliance activities relating to the import, advertising and supply requirements of the\nTherapeutic Goods Act 1989\nfrom 1 July 2024 to 30 June 2025.\n 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)`\n- 2024\nMeeting 35, 21 November 2024\nTopics discussed included -\nReview of Action items from previous meetings\nGMP Forum Wrap Up\nMQB Section and TIWGG member updates\nUpdate on new Working Groups\nNew Sterile Medicines Technical Working Group - newly formed as a result of upcoming adoption of PIC/S Version 17.\n Source: `pages/taskforces-index__05.html (https://www.tga.gov.au/about-us/committees-and-advisory-bodies/tga-industry-working-group-good-manufacturing-practice-gmp-tiwgg/tiwgg-meeting-summaries)`\n\n## Global Ideas and Case Study Inputs\n\n_No global-intelligence source text found yet. Run `CLAUDE/global-ideas-scraper.py ` to populate case-study sources._\n\n## Source Artifacts Used\n\n- `pages/about.html` - pages - https://www.tga.gov.au/about-us\n- `pages/announcements-index.html` - pages - https://www.tga.gov.au/resources/publication/meeting-statements/acv-meeting-statement-meeting-56-8-april-2026\n- `pages/announcements-index__11.html` - pages - https://www.tga.gov.au/resources/publication/meeting-statements/acv-meeting-statement-meeting-56-8-april-2026\n- `pages/announcements-index__12.html` - pages - https://www.tga.gov.au/safety/compliance-and-enforcement/compliance-management-enforcement/import-advertising-and-supply-compliance-priorities-2023-25\n- `pages/announcements-index__13.html` - pages - https://www.tga.gov.au/resources/publication/meeting-statements\n- `pages/corporate-plans-index.html` - pages - https://www.tga.gov.au/about-us/corporate-plans-and-reports\n- `pages/corporate-plans-index__00.html` - pages - https://www.tga.gov.au/about-us/corporate-plans-and-reports/tga-website-redevelopment-2022\n- `pages/homepage.html` - pages - https://www.tga.gov.au/about-tga/advisory-bodies-and-committees/advisory-committee-vaccines-acv\n- `pages/leadership.html` - pages - https://www.tga.gov.au/about-us/leadership-and-business-divisions\n- `pages/news-latest.html` - pages - https://www.tga.gov.au/news\n- `pages/taskforces-index.html` - pages - https://www.tga.gov.au/about-us/committees-and-advisory-bodies/advisory-committee-vaccines-acv\n- `pages/taskforces-index__01.html` - pages - https://www.tga.gov.au/about-us/committees-and-advisory-bodies/point-care-manufacturing-medical-devices-steering-committee-and-working-groups\n- `pages/taskforces-index__02.html` - pages - https://www.tga.gov.au/about-us/committees-and-advisory-bodies/dental-sector-working-group\n- `pages/taskforces-index__03.html` - pages - https://www.tga.gov.au/about-us/committees-and-advisory-bodies/medical-devices-consumer-working-group-mdcwg\n- `pages/taskforces-index__04.html` - pages - https://www.tga.gov.au/about-us/committees-and-advisory-bodies/tga-industry-working-group-good-manufacturing-practice-gmp-tiwgg\n- `pages/taskforces-index__05.html` - pages - https://www.tga.gov.au/about-us/committees-and-advisory-bodies/tga-industry-working-group-good-manufacturing-practice-gmp-tiwgg/tiwgg-meeting-summaries\n- `pages/taskforces-index__06.html` - pages - https://www.tga.gov.au/about-us/committees-and-advisory-bodies/tga-industry-working-group-good-manufacturing-practice-gmp-tiwgg/technical-working-groups\n- `pages/taskforces-index__07.html` - pages - https://www.tga.gov.au/about-us/committees-and-advisory-bodies/ventilator-expert-working-group-vewg\n- `pages/taskforces-index__08.html` - pages - https://www.tga.gov.au/about-us/committees-and-advisory-bodies/womens-health-products-working-group\n- `pages/taskforces-index__09.html` - pages - https://www.tga.gov.au/about-us/committees-and-advisory-bodies/breast-implant-expert-and-consumer-working-groups\n- `pages/taskforces-index__10.html` - pages - https://www.tga.gov.au/about-us/committees-and-advisory-bodies/imdrf-personalised-medical-devices-working-group\n- `other-pdfs/patient-information-materials-for-medical-implants-a-fact-sheet-for-consumers.pdf` - other-pdfs - https://www.tga.gov.au/sites/default/files/2023-05/patient-information-materials-for-medical-implants-a-fact-sheet-for-consumers.PDF\n- `other-pdfs/medical-devices-consumer-working-group-terms-of-reference.pdf` - other-pdfs - https://www.tga.gov.au/sites/default/files/2024-05/medical-devices-consumer-working-group-terms-of-reference.pdf\n\n## Gaps To Fix\n\n- No corporate plan text source found.\n- No annual report text source found.\n- No global comparison/case-study sources found.", "legislation_md": "# Advisory Committee on Vaccines - Acts and Legislation Discovery\n\n**Generated at**: 2026-05-09T21:09:02.924416+00:00\n**Entity ID**: B-002544\n**Jurisdiction**: Commonwealth\n**Portfolio**: Health, Disability and Ageing\n\n> This is an evidence-based discovery list from scraped department material. A mention does not always mean the department administers the legislation; high-confidence and official register links should be reviewed.\n\n## Summary\n\n- Source files scanned: 24\n- Unique legislation references found: 2\n\n| Type | Count |\n|---|---:|\n| Act | 1 |\n| Regulation | 1 |\n\n## Legislation References\n\n### Therapeutic Goods Act 1989\n\n**Type**: Act\n**Confidence**: high\n**Mentions**: 6\n**Register search**: https://www.legislation.gov.au/search?query=Therapeutic+Goods+Act+1989\n\n**Sources**:\n- `pages/announcements-index__12.html`\n- `pages/leadership.html`\n- `pages/taskforces-index__09.html`\n\n**Evidence contexts**:\n- Compliance Priorities 2023-25 | Therapeutic Goods Administration (TGA)\n\nImport, Advertising and Supply Compliance Priorities 2023-25\nRead about our new priority areas for compliance activities relating to the import, advertising and supply requirements of the Therapeutic Goods Act 1989 from 2023 to 2025.\nLast updated\n22 January 2026\nListen\nPrint\nShare\nLinkedIn\n(Twitter)\nFacebook\nEmail\nLoading...\nImportant update\nThe information on this page has been superseded by Compliance Principles for 2026 and 2027 available on the\nCompliance Principles\n Source: `pages/announcements-index__12.html`\n- n on this page has been superseded by Compliance Principles for 2026 and 2027 available on the\nCompliance Principles\npage.\nThe table below sets out our priority areas for compliance activities relating to the import, advertising and supply requirements of the\nTherapeutic Goods Act 1989\nfrom 1 July 2024 to 30 June 2025.\nWe have extended our Import, Advertising and Supply Compliance Priorities from the 2023-24 period into 2024-25.\nOur continued focus on these areas aims to improve public safety, address serious breaches of the legislation and\n Source: `pages/announcements-index__12.html`\n- ucts without health professional oversight, with young Australians particularly at risk, in particular where the presence of nicotine is not declared in product advertising, labelling or packaging.\nWe will dedicate resources to help ensure compliance with the Therapeutic Goods Act 1989 to complement proposed reforms to the regulation of vapes intended to help stamp out unsafe access to nicotine and other vaping products in 2023-25.\nWe will:\ngather and use intelligence to identify non-compliance\ncollaborate with federal, state and territory\n Source: `pages/announcements-index__12.html`\n- g the National Vaping Working Group and the development of a National Vaping Enforcement Framework\nexecuting search warrants, undertaking compliance monitoring and investigations, and progressing infringement notices, court actions and other actions under the\nTherapeutic Goods Act 1989\nin relation to unlawful vape importation, advertising, supply and manufacturing\nengaging directly with stakeholders involved in the lawful therapeutic vape supply chain, including managing sponsor notifications of therapeutic vape compliance with TGA standard\n Source: `pages/leadership.html`\n- hain, including managing sponsor notifications of therapeutic vape compliance with TGA standards.\nRegulatory Compliance Branch\nBranch head: Tracey Lutton\nThis branch is responsible for regulatory compliance activities relating to the offence provisions of the\nTherapeutic Goods Act 1989\n, including:\nintelligence\ncompliance\nenforcement action\n.\nThis includes unlawful advertising, import, export, manufacturing, and supply of therapeutic goods.\nRegulatory Engagement Branch\nBranch head: Sarah Syme\nThis branch is responsible for providing a range\n Source: `pages/leadership.html`\n\n### Therapeutic Goods Regulations 1990\n\n**Type**: Regulation\n**Confidence**: low\n**Mentions**: 2\n**Register search**: https://www.legislation.gov.au/search?query=Therapeutic+Goods+Regulations+1990\n\n**Sources**:\n- `pages/homepage.html`\n- `pages/taskforces-index.html`\n\n**Evidence contexts**:\n- relating to the safety, quality and efficacy of vaccines supplied in Australia including issues relating to pre-market assessment, post-market monitoring and safe use in national immunisation programs.\nThe Committee is established under Regulation 39F of the\nTherapeutic Goods Regulations 1990\nand the members are appointed by the Minister for Health.\nThe ACV was established in January 2017, following consolidation of previous functions of the Advisory Committee on the Safety of Vaccines (ACSOV) and the pre-market functions for vaccines of the Advis\n Source: `pages/homepage.html`\n- relating to the safety, quality and efficacy of vaccines supplied in Australia including issues relating to pre-market assessment, post-market monitoring and safe use in national immunisation programs.\nThe Committee is established under Regulation 39F of the\nTherapeutic Goods Regulations 1990\nand the members are appointed by the Minister for Health.\nThe ACV was established in January 2017, following consolidation of previous functions of the Advisory Committee on the Safety of Vaccines (ACSOV) and the pre-market functions for vaccines of the Advis\n Source: `pages/taskforces-index.html`\n\n## Files Scanned\n\n- `pages/about.html` (page)\n- `pages/announcements-index.html` (page)\n- `pages/announcements-index__11.html` (page)\n- `pages/announcements-index__12.html` (page)\n- `pages/announcements-index__13.html` (page)\n- `pages/contact.html` (page)\n- `pages/corporate-plans-index.html` (page)\n- `pages/corporate-plans-index__00.html` (page)\n- `pages/homepage.html` (page)\n- `pages/leadership.html` (page)\n- `pages/news-latest.html` (page)\n- `pages/taskforces-index.html` (page)\n- `pages/taskforces-index__01.html` (page)\n- `pages/taskforces-index__02.html` (page)\n- `pages/taskforces-index__03.html` (page)\n- `pages/taskforces-index__04.html` (page)\n- `pages/taskforces-index__05.html` (page)\n- `pages/taskforces-index__06.html` (page)\n- `pages/taskforces-index__07.html` (page)\n- `pages/taskforces-index__08.html` (page)\n- `pages/taskforces-index__09.html` (page)\n- `pages/taskforces-index__10.html` (page)\n- `other-pdfs/medical-devices-consumer-working-group-terms-of-reference.pages.jsonl` (pdf_pages)\n- `other-pdfs/patient-information-materials-for-medical-implants-a-fact-sheet-for-consumers.pages.jsonl` (pdf_pages)", "global_initiatives_md": 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 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