Resources
Regulator resource library
56,398 indexed Australian government compliance resources across 11 federal regulators.
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Tgacc Meeting 20 February 2020
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Tgacc Meeting 18 October 2018
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Tgacc Meeting 21 March 2019
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Tgacc Meeting 17 October 2019
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Tgacc Meeting 13 June 2019
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Webinar Risks Intentional Self Poisoning Paracetamol KEY Independent Expert Findings AND Consultation Possible Access AND Purchasing Controls
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Learn About Transformed NEW TGA Website
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Accessing AND Using Australian UDI Database Sandpit
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Viewing AND Responding Notifications Consent NON Compliance Dashboard
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Accessing AND Providing Feedback Australian UDI Database Sandpit
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Unique Device Identification Webinar 12 QA Ausudid Sandpit AND Information About UDI Consultation Paper 3
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Risks Intentional Self Poisoning Paracetamol KEY Independent Expert Findings AND Consultation Possible Access AND Purchasing Controls
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Tgacc Meeting 17 August 2022
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Unique Device Identification Webinar 14 Invited Guest Speakers Zebra Technologies Will Present UK Scan4safety Pilot
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Application Consent Import Supply OR Export Medical Device NON Compliant Essential Principles
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UDI Consultation Paper 3 Information AND Project Update
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Webinar Presentation Viewing AND Responding Notifications Consent NON Compliance Dashboard
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Observations AND Learnings UK Scan4safety Pilot
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Introduction NEW Formatting AND Structure Poisons Standard
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EU MDR Transition Webinar 1 Overview AND Management Under Australian Regulatory Framework
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EU MDR Transition Webinar 2 Manufacturer Evidence AND Variations Artg
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EU MDR Transition Webinar 3 Consent Supply AND Market Notifications
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Webinar Presentation Computerised Systems Establishing AND Maintaining Data Integrity
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GMP Forum 2023
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QA Ausudid Sandpit AND Update UDI Consultation Paper 3
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Medicinal Cannabis Fees AND Charges Information Session
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Webinar Presentation EU MDR Transition Overview AND Management Under Australian Regulatory Framework
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Webinar Presentation EU MDR Transition Manufacturer Evidence AND Variations Artg
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Tgacc Meeting 2 December 2022
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Webinar Presentation Introduction NEW Formatting AND Structure Poisons Standard
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Webinar Presentation EU MDR Transition Consent Supply AND Market Notifications
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Medicinal Cannabis Reforms Complying Therapeutic Goods Standard Medicinal Cannabis TGO 93 Order 2017
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Considerations Challenges AND Implementation
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ACM Meeting 37 3 February 2023
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ACM Meeting 38 30 31 March 2023
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ACM Meeting 39 1 2 June 2023
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ACM Meeting 40 3 4 August 2023
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ACM Meeting 41 5 6 October 2023
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ACM Meeting 42 30 November 1 December 2023
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Change Classification Mdma AND Psilocybin Enable Prescribing Authorised Psychiatrists
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ACV Meeting 40 18 January 2023
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ACV Meeting 41 9 February 2023
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ACV Meeting 42 12 April 2023
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ACV Meeting 43 7 June 2023
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ACV Meeting 44 2 August 2023
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ACV Meeting 45 4 October 2023
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ACV Meeting 46 29 November 2023
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ACB Meeting 19 26 MAY 2023
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ACB Meeting 20 1 September 2023
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ACB Meeting 21 10 November 2023
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Accm Meeting 31 20 April 2023
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Accm Meeting 32 13 July 2023
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Accm Meeting 33 9 November 2023
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Webinar Presentation Change Classification Mdma AND Psilocybin Enable Prescribing Authorised Psychiatrists
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Value UDI Procurement AND Inventory Management Hospitals
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Global Manufacturer Learnings AND Project Update
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Webinar Presentation Nicotine Vaping Products NZ Smoking Cessation Experience 15 October 2021
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Role UDI Issuing Agency
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Advertising Therapeutic Goods 2019 Code Basics
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Webinar Presentation Information Session Revised Evidence Guidelines Listed Medicines 23 March 2022
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Webinar Presentation Nicotine Vaping Products UK Smoking Cessation Experience 20 October 2021
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Challenges AND Considerations Journey Global UDI System
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Real World Experience Using Udis Healthcare
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Webinar Presentation 2021 Therapeutic Goods Advertising Code 20 January 2022
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Webinar Presentation SME Assist Meeting Your Obligations Supplying Medicinal Cannabis Australia 21 October 2021
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UDI Project Update
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Role UDI Issuing Agency Allison Mehr
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UDI Webinar NO 7 Global Manufacturer UDI Learnings
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Global Manufacturer UDI Learnings
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Webinar Presentation Pharmacovigilance Regulators Perspective
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Information TGA Good Clinical Practice GCP Inspection Program 9 MAY 2022
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Webinar Medicinal Cannabis Reforms
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Webinar Presentation Medicinal Cannabis Changes Special Access Scheme SAS AND Authorised Prescriber Applications 23 November 2021
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Webinar Presentation Medicinal Cannabis Changes Sponsor Requirements Supplying Unapproved Medicinal Cannabis Products Australia 22 November 2021
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Webinar Presentation Medicinal Cannabis Changes Special Access Scheme SAS AND Authorised Prescriber Applications 22 November 2021
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Webinar Presentation 2021 Therapeutic Goods Advertising Code 17 February 2022
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Presentation Regulatory Update Complementary AND Over Counter Medicines Branch
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Presentation Appealing TGA Decisions AND Navigating Section 60 Reviews Devices AND Medicines
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Impact European IVD Regulations Australia
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Presentation Regulation Cell AND Gene Therapies Australia
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Presentation Recall Reforms
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Presentation NEW Substance Applications Vary Permissible Ingredients Determination
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Presentation Streamlining Development Prescription Medicines Peptides Biosimilars Gmos
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Learnings AND Best Practices Compliance Patient Matched Devices
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Presentation Good Manufacturing Practice Compliance Signals
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Presentation Systematic Literature Reviews OTC AND Complementary Medicines
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Emerging Medical Device Technologies AND USE Real World Data
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TGA Presentations 2023 Arcs Annual Conference
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Update Clinical Evidence Guidelines Medical Devices
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Presentation HOT Topics Prescription Medicines
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Regulatory Update Medical Devices Authorisation Branch
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Lapses Conformity Assessment
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Reclassification Some Medical Devices Presentation
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Prescription Update Prescription Medicines Authorisation Branch
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Presentation Medicine Labelling Update Implementation Tgo91 92
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Presentation Sharing Adverse Event Data Medicines AND Vaccines
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Presentation Update Pharmacovigilance Branch
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Presentation Updates Clinical Trial Inspections AND CTA Scheme
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Presentation Regulatory Update Medical Devices Surveillance Branch
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Presentation Transitioning Provisional Full Approval
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Australian UDI Update Workshop Summary AND Ausudid PRE Production Demonstration
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Insights TGA Good Clinical Practice GCP Inspection Program Session ONE 7 August 2023
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Insights TGA Good Clinical Practice GCP Inspection Program Session TWO
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Updated Reporting Requirements Safety Issues Understanding Changes PV Guidelines Webinar 1
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Updated Reporting Requirements Safety Issues Understanding Changes PV Guidelines Webinar 2
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Project Checkpoint What WE Know AND What YOU CAN DO GET Involved
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NEW Medical Devices Vigilance Program Information Session Medical Device Sponsors Australia
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Australian UDI Project Update AND Discussing Considerations AND Real World Benefits Adopting UDI Healthcare
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Vaping Reforms Overview Regulatory Changes
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Considerations Australian UDI
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Personalised Medical Devices Framework
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Webinar Presentation Unique Device Identification 15 June 2021
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BIA Alcl AND Breast Augmentations
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Webinar Recording BIA Alcl AND Breast Reconstructions
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Medicine Shortages Reforms Webinar
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Prescribing Therapeutic Vapes Overview Regulatory Changes
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Medicines Repurposing Program Support NEW Clinical Uses Existing Medicines 12 March 2024
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Medicines Repurposing Program Support NEW Clinical Uses Existing Medicines
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Tgacc Meeting 18 September 2023
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Updates CTN Form AND First Human High Risk Implantable OR Cardiac Invasive Medical Device Clinical Trials 14 March 2024
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Presentation Advertising Cosmetic Injection Health Services Compliant Therapeutic Goods Legislation
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GMP Forum 2024
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Presentation Nata TGA IVD Information Session 1 Refresher Regulatory Framework House Ivds
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EU Medical Device Regulation Presentation Implications Australia
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Presentation Nata TGA IVD Information Session 2 Data Requirements AND Assessment Approach Including Companion Diagnostics
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Introduction NEW House IVD Notification Form
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TGA Digital Transformation Webinar Making IT Easier AND Faster DO Business US
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Presentation Proposed Changes Regulation Exempt Medical Devices AND Exempt Other Therapeutic Goods
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Presentation Progress Next Update TGA Standards Nicotine Vapes AND Vaping Devices
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Tgacc Meeting 7 March 2024
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ACM Meeting 43 1 AND 2 February 2024
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Good Clinical Practice GCP Inspection Program Clinical Trials Medicines Biologicals AND Devices 30 MAY 2024
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Presentation Preparing Product Information Document Generic Medicine Quality AND Regulatory Expectations
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Presentation Understanding What Vaping Reforms Mean GPS
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Presentation Changes Regulation Compounding Glucagon Peptide 1 Receptor Agonist GLP 1 RA Products
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Update Manufacturing Quality Branch
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TGO 91 Compliance Workshop
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Medicines Repurposing Program
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TGO 92 Compliance Workshop
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Aiml Medical Devices
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Update Medical Devices Authorisation Branch
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Update Complementary AND OTC Medicines Branch
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Vaping Reforms AND Implementation
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Impact European Medical Device Directive Medical Device Regulations Transition Australian Regulatory Landscape
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Medical Devices Surveillance Branch Regulatory Update
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Regulatory Update Medical Devices Surveillance Branch
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Risk Management
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TGA Clinical Trial Landscape Updates
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Update Pharmacovigilance Branch 0
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Prescription Medicines Authorisation Branch Annual Update
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CMC Variations Navigating Grey Zones
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HOW Make Sense RNA Based Therapeutics
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Nitrosamine Impurities Medicines
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Arcs Annual Conference 2024 TGA Presentations
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Presentation ICH E2cr2 Guideline AND Pbrer Template
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Presentation Reforming Australias Therapeutic Goods Testing Regulations
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Presentation Medical Devices Essential Principles Safety AND Performance Part 2 Proposed Alignment European Regulations
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Software Reclassification Reforms Webinar Q AND Software Transition Deadline 1 November 2024
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Updates Medical Device Post Market Review Compliance Dashboard Exempt Vape Devices AND Accessories
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Consent Supply Vape Devices AND Accessories DO NOT Comply Essential Principles Opportunity Provide Feedback
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Future Regulation Assistive Technologies Information Session
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Presentation Product Standards Therapeutic Vaping Goods Webinar Overview Changes Product Standards Commencing Early 2025
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Tgacc Meeting 20 September 2024
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Regulation Times Pandemic
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Clean Room Requirements Biologicals
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Code Tables GMP Clearances
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GMP Clearance Common Deficiencies
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GMP Inspection Trends NON Sterile Registered Medicines
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GMP Licence Applications
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GMP Overview AND Update Pics Guide GMP Medicinal Products Version 14
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HOW Improve Your GMP Compliance Listed Medicines AND GMP Implementation Tgos 92 AND 101
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Inspection Reliance
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Management GMP Compliance Signals
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Manufacturing Investigational Medicinal Products
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Overview GMP Regulatory Activities
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Quality Control Biotechnological OR Biological Medicines
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Remote GMP Inspections Current Feedback AND Future Considerations
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Remote Inspections TGA Manufacturing Quality Perspective
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Special Access Scheme Portal
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Sterile Medicines Lessons Strugglepharm
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TGO 110 Standard Unapproved Vaporiser Nicotine Products 4 March 2021
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Meeting Your Obligations
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TGA Transformation Stakeholder Engagement Forums
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Good Manufacturing Practice GMP Forum 2021 Online 12 14 MAY 2021
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SME Assist Meeting Your Obligations Advertising
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SME Assist Meeting Your Obligations Basics Therapeutic Goods Regulation
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SME Assist Meeting Your Obligations Manufacturing
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SME Assist Meeting Your Obligations Market Authorisation
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SME Assist Meeting Your Obligations Post Market Monitoring
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Proposed Changes WAY Nicotine Supplied Consumers AND Health Practitioners 8 OCT 2020
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Proposed Changes WAY Nicotine Supplied Consumers AND Health Practitioners 9 OCT 2020
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Proposed Changes WAY Nicotine Supplied Suppliers 8 OCT 2020
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Presentation Procedure Recalls Product Alerts AND Product Corrections Prac What YOU Need Know
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TGA Clinical Trial Initiatives 0
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Information Webinar Proposed Changes WAY Nicotine Supplied
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Online Presentation Work Sharing Reliance AND Other Novel Approaches Accelerating Review Approvals AND Access
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NEW Form Notification Therapeutic Vaping Goods
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Presentation Application Consent Import Supply OR Export Unapproved Medical Devices ARE NON Compliant Essential Principles
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Presentation Reporting Medicine Adverse Events 30 March 2022
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Presentation Relying Combined Global Regional AND Country Information Pharmacovigilance