Resources
Regulator resource library
56,398 indexed Australian government compliance resources across 11 federal regulators.
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Step 12 Making Decision
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Step 13 Finalising Your Application
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Licensing AND Certification Process
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1 Determining Whether Licensing OR Certification Required
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2 Complying Manufacturing Principles
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3 Becoming TGA Client
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4 Compiling Documentation
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5 Making Statutory Declaration
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6 Drafting AND Submitting Your Application
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7 Application Fees
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8 Determining Whether Your Application Effective
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9 Determining Inspection Type AND Scheduling Inspection
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10 Paying Inspection Invoices
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11 Preparing Inspection
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12 Inspection
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13 Post Inspection Letter PIL
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14 Addressing Deficiencies
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15 Reviewing Your Response AND Closeout
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16 Issuing Inspection Report
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17 Paying Your Final Invoice
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18 Providing Feedback
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19 Making Decision
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20 Granting Licences AND Issuing Certification
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21 Conducting Follow Inspections
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22 Keeping US Date AND Making Requests
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Contacting Manufacturing Quality Branch
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Australian Manufacturing Licences AND Overseas GMP Certification Version History
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Preparing Your Ectd Dossier
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AU Regional File Formats
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Other AU Regional Considerations
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AU Module 1 General Architecture
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Ectd Preparation Tools
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Change Control
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Version History
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Version History
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Trouble Shooting TBS Portal
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Version History
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Version History
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Attachment 1
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Submission
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Completing Application
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Data Quality Principles Icsrs
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Registration E2B R2 Adverse Event Reporting
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Connecting EDI Service
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Generating Valid ICH Safety Message
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Icsr Business Rules
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Acknowledgment Reports
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Updating Previously Submitted Iscrs
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Privacy AND Data Security
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TGA Specific Validation Rules
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Test Scenarios USE E2B Standard
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Completing Application Form
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Validate Your Application Prior Submitting
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Submitting Your Application
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Version History
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11 Appendix H
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21 Crisaborole
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22 Brigatinib
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23 Lanadelumab
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24 Romosozumab
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Using Electronic Notification Form
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Getting Started
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Completing Notification Form
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Accessing Notification Form
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Varying Updating Notification Form
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Publishing Notification Form
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Appendix 1
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Version History
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Preparing Make Application
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Prescription Medicines Collection
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Search Covid 19
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Philips Recall Action Cpap BI Level PAP Devices AND Mechanical Ventilators Collection
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Ozempic Semaglutide Safety Collection
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Pholcodine Cough Medicines Recall Collection
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Updates Listed Medicine Ingredients
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Advisory Committee Biologicals ACB
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Advisory Committee Complementary Medicines Accm
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Advisory Committee Medical Devices Acmd
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Advisory Committee Chemicals Scheduling Accs
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Australian Influenza Vaccine Committee Aivc
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Regulatory AND Technical Consultative Forum Medical Devices Regtech Forum
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Advisory Committee Medicines Scheduling Acms
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Advisory Committee Medicines ACM
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Advisory Committee Vaccines ACV
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TGA Industry Working Group Good Manufacturing Practice GMP Tiwgg
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Complementary AND OTC Medicines Regulatory AND Technical Consultative Forum Comtech
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Dental Sector Working Group
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Womens Health Products Working Group
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Medical Devices Consumer Working Group Mdcwg
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Ventilator Expert Working Group Vewg
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Point Care Manufacturing Medical Devices Steering Committee AND Working Groups
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Human Research Ethics Committee AND Therapeutic Goods Administration Clinical Trials Discussion Forum
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Therapeutic Goods Advertising Consultative Forum Tgacf
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Consultation Invitation Public Comment Accs Acms AND Joint Accsacms Meetings July 2014
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Consultation Invitation Public Comment Acms Meeting July 2014
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Consultation Invitation Public Comment Accs Acms AND Joint Accsacms Meetings March 2014
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Consultation Invitation Public Comment Acms Meeting March 2014
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Consultation Invitation Public Comment Accs AND Joint Accsacms Meetings November 2013
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Consultation Invitation Public Comment Acms Meeting November 2013
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Consultation Invitation Public Comment Accs AND Joint Accsacms Meetings July 2013
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Invitation Public Comment Acms Meeting July 2013
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Notice Amended Publication Date Invitation Public Comment Acms Meeting July 2013
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Invitation Public Comment Accs Meeting March 2013
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Invitation Public Comment Acms AND Accs Meetings March 2013
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Invitation Public Comment Acms AND Accs Meetings October 2012
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Invitation Public Comment Acms AND Accs Meetings February 2012
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Invitation Public Comment Acms AND Accs Meetings June 2012
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Invitation Public Comment Acms AND Accs Meetings October 2011
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Invitation Public Comment Acms AND Accs Meetings June 2011
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Supplementary Invitation Public Comment Acms Meeting February 2011
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Invitation Public Comment Acms AND Joint Acmsaccs Meetings February 2011
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Invitation Public Comment Acms AND Joint Acmsaccs Meetings
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Consultation Invitation Public Comment Accs Acms AND Joint Accsacms Meetings November 2014
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Consultation Invitation Public Comment Acms AND Joint Accsacms Meetings November 2014
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Consultation Invitation Public Comment OUT Session Acms Meeting November 2014
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Consultation Invitation Public Comment Acms Meeting March 2015
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Consultation Invitation Public Comment Accs Meeting March 2015
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Consultation Invitation Public Comment Accs Meeting AND Joint Accsacms Meeting July 2015
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Consultation Invitation Public Comment Acms Meeting July 2015
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Consultation Proposed Amendments Poisons Standard Acms Meeting November 2015
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Consultation Proposed Amendments Poisons Standard Accs AND Acms Meetings November 2015
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Consultation Proposed Amendments Poisons Standard Acms Meeting March 2016
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Consultation Proposed Amendments Poisons Standard Codeine
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Consultation Proposed Amendments Poisons Standard Acms Meeting July 2016
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Consultation Proposed Amendments Poisons Standard Accs AND Joint Accsacms July 2016
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Consultation Proposed Amendments Poisons Standard Acms Meeting November 2016
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Consultation Proposed Amendments Poisons Standard Accs AND Acms Meetings November 2016
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Consultation Proposed Amendments Poisons Standard Joint Accs AND Acms Meeting November 2016
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Consultation Proposed Amendments Poisons Standard Accs Acms AND Joint Accsacms Meetings March 2017
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Consultation Further Proposed Amendments Poisons Standard Joint Accs AND Acms Meeting AND Accs Meeting March 2017
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Consultation Proposed Amendments Poisons Standard Accs Acms AND Joint Accsacms Meetings July 2017
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Consultation Proposed Amendments Poisons Standard Joint Accsacms Meeting July 2017
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Consultation Proposed Amendments Poisons Standard Accs Acms AND Joint Accsacms Meetings November 2017
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Consultation Proposed Amendments Poisons Standard Accs Acms AND Joint Accs Acms Meetings March 2018
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Consultation Proposed Amendments Poisons Standard Being Referred June 2018 Meetings Accs Acms AND Joint Accsacms
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Consultation Referral Proposed Amendments Current Poisons Standard Acms Joint Accs Acms OR Accs Meeting November 2018
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Consultation Referral Proposed Amendment Current Poisons Standard Meeting Acms March 2019
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Consultation Proposed Amendments Poisons Standard Accs Acms AND Joint Accsacms Meetings March 2019
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Consultation Proposed Amendments Poisons Standard Accs Meeting March 2019
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Consultation Proposed Amendments Poisons Standard Accs Acms AND Joint Accsacms Meetings June 2019
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Consultation Proposed Amendments Poisons Standard Accs Meeting June 2019
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Consultation Proposed Amendments Poisons Standard Acms AND Accs November 2019
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Consultation Proposed Amendments Poisons Standard Acms AND Joint Accsacms Meetings November 2019
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Consultation Proposed Amendments Poisons Standard Accs Acms AND Joint Acmsaccs Meetings March 2020
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Consultation Proposed Amendments Poisons Standard Joint Accsacms Meetings March 2020
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Consultation Proposed Amendments Poisons Standard Acms AND Joint Acmsaccs Meetings June 2020
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Consultation Proposed Amendments Poisons Standard Joint Acmsaccs Meetings June 2020
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Consultation Proposed Amendments Poisons Standard Acms Accs AND Joint Acmsaccs Meetings November 2020
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Consultation Proposed Amendments Poisons Standard Acms Accs AND Joint Acmsaccs Meetings March 2021
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Consultation Proposed Amendments Poisons Standard Acms 34 June 2021
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Consultation Proposed Amendments Poisons Standard Oral Contraceptives Acms 34 June 2021
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Consultation Proposed Amendments Poisons Standard Accs 31 June 2021
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Consultation Proposed Amendments Poisons Standard Joint Acmsaccs 28 June 2021
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Consultation Proposed Amendments Poisons Standard Sodium Nitrite Joint Acmsaccs 28 June 2021
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Consultation Proposed Amendments Poisons Standard Accs Acms AND Joint Accsacms Meetings November 2021
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Consultation Proposed Amendments Poisons Standard Accs Acms AND Joint Accsacms Meetings March 2022
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Consultation Proposed Amendments Poisons Standard Accs Acms AND Joint Accsacms Meetings June 2022
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Joint TGA AND Medsafe Project Trans Tasman Early Warning System Safety Concerns Medicines AND Medical Devices
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Anztpa Implementation Release High Level Description Possible Joint Regulatory Scheme
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Consultation Proposed Amendments NEW Regulatory Framework Vitro Diagnostic Medical Devices Ivds
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Consultation Supply Vitro Diagnostic Devices Self Testing Home Testing Presence Human Immunodeficiency Virus Australia
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Consultation Regulation Impact Statement Changes Premarket Assessment Requirements Medical Devices
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Consultation Changes Premarket Assessment Requirements Medical Devices Proposal Paper
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Consultation Loratadine AND Desloratadine Proposed Advisory Statements Medicines
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Changes TGA Sunscreen Guidelines AND Related Legislation
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Consultation Fexofenadine AND Loperamide Proposed Advisory Statements Medicines
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Review Arrangements Scheduling Medicines AND Poisons
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Reforms Medical Devices Regulatory Framework
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Public Access Information Contained Artg Entries Therapeutic Goods
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USE Third Party Conformity Assessment Bodies Medical Devices Supplied Australia
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Draft Guidance Regulation Custom Made Medical Devices
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Regulation Hypoxic Therapy AND Altitude Training Devices Hypoxicators Australia
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Updated Medical Device Conformity Assessment Standards Orders
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Medical Device AND Conformity Assessment Standards Orders
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Draft Guidelines Vitro Diagnostic Goods Home USE
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Labelling Project 9900 Effective Design
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Regulation NEW Excipients Topical NON Prescription Medicines
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Proposed NEW Model Scheduling Medicines AND Poisons Within Joint Agency
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TGA Communications AND Consultation Processes Online Survey 2009
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Consultation TGA Adoption TWO European Union EU Scientific Guidelines Herbal Medicines Attachment
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Consultation TGA Adoption TWO European Union EU Scientific Guidelines Herbal Medicines Attachment B
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Consultation Proposed Performance Requirements AND Risk Mitigation Strategies HIV Tests
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Consultation Draft Clinical Evidence Guidelines Medical Devices
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Consultation Software Medical Device Samd Clinical Evaluation
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Consultation Designation Australian Conformity Assessment Bodies Medical Devices Implementation
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Consultation Implementation Accelerated Assessment Medical Devices Priority Review
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Consultation Scheduling Policy Framework AND Advertising Pharmacist Only Medicines Schedule 3 Substances
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Consultation Options Future Regulation LOW Risk Products
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Consultation Comparable Overseas Medical Device Regulators
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Consultation Alignment European Medical Device Regulatory Framework
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Consultation Discontinuing PRE Market Evaluation Herbal Component Names Hcns
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Consultation Proposed Regulatory Changes Related Personalised AND 3D Printed Medical Devices
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Consultation Prescription Strong Schedule 8 Opioid USE AND Misuse Australia Options Regulatory Response
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Consultation Proposed Schedule 3 Substances BE Added Appendix H Poisons Standard
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Consultation Boxed Warning Guidance
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Imdrf Consultation Unique Device Identification System
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Imdrf Consultation Principles Labelling Medical Devices AND IVD Medical Devices
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Imdrf Consultation Terminologies Categorised Adverse Event Reporting
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Consultation Proposal Regulation IVD Companion Diagnostics
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Consultation Regulatory Options Appropriate Access AND Safety Controls Alkyl Nitrites