Regulator resource library

tga

Consultation Medical Device Cyber Security

tga

Consultation Proposal Introduce Unique Device Identification UDI System Medical Devices Australia

tga

Consultation Potential Reclassification Active Medical Devices Diagnosis AND Patient Therapy

tga

Consultation Changes Number Definitions AND Scope Medical Device Regulatory Framework Australia

tga

Consultation Proposed Regulatory Scheme Personalised Medical Devices Including 3D Printed Devices

tga

Consultation Proposed Reclassification Spinal Implantable Medical Devices

tga

Consultation Regulation Software Including Software Medical Device Samd

tga

Consultation Proposed Criteria Appendix M Poisons Standard Support Rescheduling Substances Schedule 4 Prescription Only Schedule 3 Pharmacist Only

tga

Consultation Proposed NEW Classification Rule Medical Devices Administer Medicines OR Biologicals Inhalation

tga

Consultation Proposed Medical Device Classification Human Cells Tissues AND Organs Storage Solutions AND IVF Media

tga

Consultation Proposed NEW Medical Device Classification Substances Introduced Body Body Orifice OR Applied Skin

tga

Consultation Proposed Changes Classification Active Implantable Medical Devices AND Their Accessories

tga

Consultation Proposed Changes Classification Medical Devices Used Direct Contact Heart Central Circulatory OR Central Nervous Systems

tga

Imdrf Consultation Personalised Medical Devices Regulatory Pathways

tga

Consultation Changes Permissible Ingredients LOW Negligible Risk

tga

Consultation Proposed Clarification Goods ARE Therapeutic Goods Goods Containing Folate Substances Certain Circumstances

tga

Consultation Proposed Changes Medical Device Essential Principles Safety AND Performance

tga

Consultation Proposed Clarification Regulatory Requirements Medical Device Systems AND Procedure Packs

tga

Imdrf Consultation Good Regulatory Review Practices Requirements Conformity Assessment Bodies

tga

Consultation Products Used AND People Disabilities

tga

Consultation Review Regulation Certain Self Testing Ivds Australia

tga

Targeted Consultation Review Chemical Scheduling Relation Cosmetic AND Fragrance Ingredients

tga

Consultation Export Therapeutic Goods Australia

tga

Consultation Scope Regulated Software Based Products

tga

Imdrf Consultation Recognition AND Surveillance Medical Device Conformity Assessment Bodies

tga

Imdrf Consultation Competence AND Training Requirements Regulatory Authority Assessors Conformity Assessment Bodies

tga

Consultation Proposed Enhancements Adverse Event Reporting Medical Devices

tga

Consultation Exploring Options Introduction Australian Unique Device Identification UDI System

tga

Imdrf Consultation Proposed Update Document Post Market Clinical Follow Studies

tga

Consultation Potential Reforms Medicinal Cannabis Manufacturing Labelling AND Packaging Requirement

tga

Consultation Australian Medical Device Regulations Definition Central Circulatory System CCS

tga

Consultation Proposal Remove Redundant Processes Entering Certain Formulation Information Therapeutic Goods Application

tga

Consultation Fees AND Charges Proposal 2021 22

tga

Consultation Repurposing Prescription Medicines

tga

Consultation Standard Vaporiser Nicotine TGO 110

tga

Consultation Proposed Regulatory Options Medical Devices Containing Nanomaterials

tga

Consultation Proposal Clarifying Regulatory Requirements Residual Claims Disinfectants

tga

Imdrf Consultation Assessment AND Decision Process Recognition Conformity Assessment Body Conducting Medical Device Regulatory Reviews

tga

Consultation Building More Robust Medicine Supply Proposals Help Prevent Mitigate AND Manage Medicine Shortages

tga

Consultation Proposed Changes Required Advisory Statements Medicine Labels Rasml Methyl Salicylate

tga

Consultation Proposed Changes Required Advisory Statements Medicine Labels Rasml Lidocaine Lignocaine

tga

Consultation Proposed Changes Required Advisory Statements Medicine Labels Rasml Sedating Antihistamines

tga

Consultation Proposed Changes Required Advisory Statements Medicine Labels Rasml Menthol

tga

Consultation Proposed Improvements Therapeutic Goods Advertising Code

tga

Consultation Remaking Standards AND Legislative Instruments Human Cell AND Tissue HCT Products Blood AND Blood Components

tga

Consultation Proposed Refinements Regulation Personalised Medical Devices

tga

Consultation Proposed Refinements Regulation Medical Devices ARE Substances Introduced Human Body Body Orifice OR Applied Skin

tga

Consultation Proposed Changes Permissible Ingredients Determination LOW Negligible Risk Changes 2021 22

tga

Consultation Proposed Changes Required Advisory Statements Medicine Labels Rasml Melatonin

tga

Consultation Proposed Changes Required Advisory Statements Medicine Labels Rasml Triptans

tga

Consultation Proposed Changes Required Advisory Statements Medicine Labels Rasml Mometasone

tga

Consultation Proposed Minor Changes Required Advisory Statements Medicine Labels Rasml Chlorhexidine Hydrocortisone Ibuprofen

tga

Consultation Draft Guidance Assistive Technologies AND Therapeutic Goods Excluded Goods Determination 2021

tga

Consultation Proposed Refinements Requirements Medical Device Patient Information Materials

tga

Discussion Paper Potential Mandatory Reporting Medical Device Adverse Events Healthcare Facilities Australia

tga

Consultation Potential Regulatory Options Export Only Biologicals

tga

Consultation Extemporaneous Compounding Emergency Medicines

tga

Consultation Adoption International Scientific Guidelines Australia Closed February 2022

tga

Consultation Improving Access Medicine Adverse Event Data Sponsor Survey

tga

Consultation Fees AND Charges Proposal 2022 23

tga

Consultation Priority Review Pathway Biologicals Feasibility Potential Eligibility Criteria AND Determination Process

tga

Consultation Proposed Update Evidence Guidelines Listed Medicines

tga

Consultation Repurposing Medicines

tga

Consultation 2022 2023 Proposed Changes Permissible Ingredients Determination LOW Negligible Risk

tga

Consultations Adoption European Union Guidelines Australia

tga

Consultation Proposed Regulatory Changes Clinical Trials Medical Devices

tga

Consultation Detailed Considerations Implementing Proposed Australian Medical Device UDI Regulatory Framework

tga

Consultation Product Information Package Insert Boxed Injectables

tga

Consultation Proposed Amendments Poisons Standard Accs Acms AND Joint Accsacms Meetings November 2022

tga

Consultation Proposed Amendments Poisons Standard Relation Paracetamol Acms Meeting November 2022

tga

Consultation Regulatory Options Potentially Allow References TGA Therapeutic Goods Advertising

tga

Consultation Adoption International Scientific Guidelines Australia Closed November 2022

tga

Consultation Draft Guidance Boundary AND Combination Products Medicines Medical Devices AND Biologicals

tga

Consultation International Harmonisation Ingredient Names Ihin Dual Labelling Transition Sole Medicine Ingredient Names

tga

Consultation Proposed Reforms Regulation Nicotine Vaping Products

tga

Consultation Proposed Amendments Poisons Standard Acms Accs AND Joint Acms Accs Meetings March 2023

tga

Consultation TGA Fees AND Charges Proposal 2023 24

tga

Consultation Seeking Feedback Improvements Recalls Process

tga

Consultation Proposed Amendments Poisons Standard Acms AND Joint Acms Accs Meetings June 2023

tga

Impact Amendments Application Process Inclusion Class I Medical Devices Australian Register Therapeutic Goods Artg

tga

Adoption International Scientific Guidelines Australia

tga

Public Consultation Interim Decisions Amend Poisons Standard Acms 40 November 2022 Paracetamol

tga

Public Consultation Interim Decisions Amend Poisons Standard Isothiazolinones Joint Acms Accs June 2020

tga

Public Consultation Interim Decisions Amend Poisons Standard Sodium Nitrite Joint Acms Accs June 2021

tga

Public Consultation Interim Decisions Amend Poisons Standard Joint Acms Accs June 2021

tga

Public Consultation Interim Decisions Amend Poisons Standard Acms Accs Joint Acms Accs November 2022

tga

Public Consultation Interim Decisions Amend Poisons Standard June Acms Interim Decisions Psilocybine AND Mdma 2022

tga

Public Consultation Interim Decisions Amend Poisons Standard Oral Contraceptives Acms June 2021

tga

Public Consultation Interim Decisions Amend Poisons Standard Acmsaccsjoint Acms Accs June Interim Decisions 2022

tga

Public Consultation Interim Decisions Amend Poisons Standard Acms June 2021

tga

Public Consultation Interim Decisions Amend Poisons Standard Acmsaccs Meetings March 2021

tga

Public Consultation Interim Decisions Amend Poisons Standard Acmsaccs Joint Meetings March 2022

tga

Public Consultation Interim Decisions Amend Poisons Standard November 2020 Acmsaccs Meetings

tga

Public Consultation Interim Decisions Amend Poisons Standard Acms Accs Joint Acms Accs November 2021

tga

Notice Interim Decision Amend Current Poisons Standard Relation Nicotine Joint Acms Accs Meeting June 2020

tga

Public Consultation Interim Decisions Amend Poisons Standard Isothiazolinones Joint Acms Accs June 2020 0

tga

Public Consultation Proposed Amendments Poisons Standard Acmsaccsjoint Acms Accs June 2022

tga

Consultation NEW Therapeutic Goods Order 106 Data Matrix Codes AND Serialisation Medicines

tga

Public Consultation Interim Decisions Amend Poisons Standard Acms Accs Joint Acms Accs November 2021 0

tga

Notice Interim Decisions Amend OR NOT Amend Current Poisons Standard Acmsaccsjoint Acms Accs Meeting June 2020

tga

Consultation Allied Health Professionals Point Care Manufacturing Survey

tga

Consultation Dental AND Oral Health Professionals Point Care Manufacturing Survey

tga

Consultation Hospital AND Healthcare Facility Survey

tga

Consultation Medical Device Manufacturing Hubs Point Care Survey

tga

Consultation Clarification AND Updates Regulation Sunscreens

tga

Consultation Review Regulatory Requirements Medical Devices Containing Materials Animal Microbial OR Recombinant Origin

tga

Consultation Increased Online Access Ingredient Information

tga

Consultation Guidelines Quality Listed Probiotic Medicines

tga

Proposed Application Audit Framework Medical Devices

tga

Consultation 2023 2024 Proposed Changes Permissible Ingredients Determination LOW Negligible Risk

tga

Consultation Proposed Amendments Poisons Standard Acms Accs AND Joint Acms Accs Meetings November 2023

tga

Consultation Proposed Quality Standards Mdma AND Psilocybin

tga

Consultation Proposed Amendments Poisons Standard Acms Accs AND Joint Acms Accs Meetings March 2024

tga

Consultation Adoption International Scientific Guidelines Australia R01 2023

tga

Consultation Medicine Shortages Australia Challenges AND Opportunities

tga

Consultation Clarification HOW Clinical Decision Support System Cdss Software Regulated

tga

Consultation Availability Instructions USE IFU More Flexible Formats

tga

Consultation Proposed Changes Regulation Exempt Medical Devices AND Exempt Other Therapeutic Goods

tga

Consultation Proposed Amendments Poisons Standard Acms Accs AND Joint Acms Accs Meetings June 2024

tga

Public Consultation Interim Decisions Amend Poisons Standard Acms Accs Joint Acms Accs November 2023

tga

Consultation Companion Diagnostics Guidance Update

tga

Consultation Updates Australian Medicine Labelling Rules Support Medicine Safety

tga

Consultation Legislating Regulatory Categories Some Boundary AND Combination Products

tga

Consultation Reforming Australias Therapeutic Goods Testing Regulations

tga

Consultation Proposed Exposure Model Assessing Safety Sunscreen Ingredients Australia

tga

Consultation Revision Guidance Document TGA Instructions Disinfectant Testing

tga

Consultation Future Regulation Assistive Technologies

tga

Consultation Medical Devices Essential Principles Part 2 Proposed Alignment European Regulation

tga

Consultation 2024 2025 Proposed Changes Permissible Ingredients Determination LOW Negligible Risk

tga

Consultation Therapeutic Goods Order NO 70C Standards Export Only Medicine

tga

Consultation Draft Guidance Regulatory Changes Medical Devices Containing Medicinal Substances OR Materials Animal Microbial OR Recombinant Origin

tga

Consultation Clarifying AND Strengthening Regulation Artificial Intelligence

tga

Consultation Temporary Labelling Exemptions Paracetamol

tga

Consultation Proposed Amendments Poisons Standard Acms AND Joint Acms Accs Meetings November 2024

tga

Public Consultation Interim Decisions Amend Poisons Standard Acms Accs Joint Acms Accs June 2024

tga

Consultation Medicine Shortages AND Discontinuations Reportable Medicines AND Timeframes Reporting Discontinuations

tga

Consultation Adoption International Scientific Guidelines Australia R01 2024

tga

Consultation Proposed Changes Permissible Ingredients Determination LOW Negligible Risk Changes 2020 21

tga

Consultation Draft Guidance Documents Medical Device Audit Framework

tga

Consultation Draft Standards Faecal Microbiota Transplant FMT Products

tga

Consultation Options Regulation Faecal Microbiota Transplantation Materials

tga

Consultation Proposed Amendments Poisons Standard Accs AND Joint Acms Accs Meetings March 2025

tga

Consultation Proposed Changes IVD Medical Device Classifications AND Definitions

tga

Consultation Proposed Amendments Poisons Standard Acms AND Joint Acms Accs Meetings June 2025

tga

Consultation Proposed Amendments Poisons Standard Acms Meeting June 2025

tga

Consultation Adoption International Scientific Guidelines Australia R02 2024

tga

Consultation Proposed Amendments Poisons Standard Relation Homosalate Oxybenzone AND Benzophenone Joint Acms Accs Meeting September 2025

tga

Consultation Reviewing Safety AND Regulatory Oversight Unapproved Medicinal Cannabis Products

tga

Consultation Product Information Package Insert Consumer Administered Injectables

tga

Consultation Proposed Amendments Poisons Standard Accs Acms AND Joint Acms Accs Meetings November 2025

tga

Survey Digital Mental Health Tools

tga

Consultation Provisions Regularise Technical Master File Tmfs AND Type II Plasma Master File Pmfs Processes

tga

Consultation Proposed GMP Exemption Certain Bacteriophage Manufacture

tga

Consultation Proposed Changes Regulation Medicinal Maggots

tga

Consultation Adoption International Scientific Guidelines Australia R01 2025

tga

Consultation Proposed Changes Labelling Medicines Supplied Australia

tga

Survey Users Digital Mental Health Tools

tga

Public Consultation Proposed Changes Medical Device Conformity Assessment Procedures

tga

Consultation Proposed Amendments Poisons Standard Accs Acms AND Joint Acms Accs Meetings March 2026

tga

Consultation Proposed Amendments Relating Transparency Disruptions Supply Medical Device

tga

Consultation TGA Fees AND Charges Proposal 2026 27

tga

Consultation TGA Annual Charge Exemption ACE Scheme Compliance Program Updates Proposal 2026 27

tga

Consultation Personalised Medical Devices Consumer Survey

tga

Consultation Improvements Regulation Sunscreens Australia

tga

Facemask Cancellations

tga

Cancellations Suspensions

tga

Covid 19 Disinfectants

tga

Annual Charge Exemptions

tga

Facemask Market Actions

tga

Cancellations FOR Failure TO PAY

tga

Listed Medicine Compliance Reports

tga

Prescription Medicines Under Evaluation

tga

Prescription Medicines Registrations

tga

Face Mask NON Compliance

tga

Section 14 Consents

tga

Section 14 Tgo91 Consents

tga

Section 19A Approvals

tga

Cancellations BY Sponsors

tga

Designations Determinations

tga

Artg

tga

Sponsor

tga

Articles

tga

Alerts

tga

Publication

tga

Resources

tga

Events

tga

Consultations

tga

Advertising Permissions

tga

Auspar

tga

Auspmd

tga

Covid 19 Test Kits

tga

C19v

tga

Search

tga

Archive

tga

Meeting Outcomes

tga

Meetings

tga

Medicine Shortage Reports Database

tga

Australian Manufacturer Search

tga

Conformity Assessment Certificate Search

tga

Indications Listed Medicines