Resources
Regulator resource library
56,398 indexed Australian government compliance resources across 11 federal regulators.
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Submissions Received Reforms Generic Medicine Market Authorisation Process
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Fast Track Approval Pathways
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Inclusions NEW Biologicals
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Guidance Therapeutic Goods Conformity Assessment Standard Quality
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Overview Permitted Indications AND Transition Arrangements
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HOW Remove Indications AND ADD Permitted Indications Your Existing Medicine
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Selecting Parent Indications AND Linking Indications
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Documents Released Under Section 11C Freedom Information ACT 1982 JUL 2018 JUN 2019
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Cosmetic Injections
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Infringement Notices
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Importing Therapeutic Goods
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Changes WAY Modified Release Paracetamol Products ARE Supplied Questions AND Answers
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Revocation TGA Issued Conformity Assessment Certificate
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Ingredients Therapeutic Goods
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Proprietary Ingredient Formulations AND HOW They ARE Used
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Forms NEW Ingredient Names AND Proprietary Ingredients
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Medicine Registration Fundamentals
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Manufacturer Evidence Medical Devices
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Distribution Records
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Medical Device Post Market Reviews
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NEW Therapeutic Goods Declared Goods Order 2019
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Imdrf Personalised Medical Devices Working Group
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Annual Charge Exemption ACE Scheme Entries Declaring 0 Turnover
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Medical Devices Including Ivds Priority Applicant Determination Notices
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Medicines Suspensions Artg
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Outcomes Changes Permissible Ingredients LOW Negligible Risk
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HOW Interpret Compliance Review Results
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Prescription Medicines Determination AND Designation Notices
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List Comparable Overseas Bodies Cobs
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Section 47B Instruments
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Submissions Received AND TGA Response Increased Online Access Ingredient Information
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Breast Implant Expert AND Consumer Working Groups
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Researcher Considerations
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Educational Videos
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Outcomes Reclassification Number Medical Devices Following Consultations 2019
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Applying TGA Assessment Covid 19 Test Inclusion Artg
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Covid 19 Test Kits Included Artg Legal Supply Australia
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HOW Testing Works Covid 19
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Covid 19 Testing Australia Information Health Professionals
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Covid 19 Serology Point Care Tests
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Submissions Received Whether TGA Should Publish Prescription Medicine Under Evaluation
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Post Market Review Covid 19 Point Care Tests
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What Ingredients ARE MY Medicine
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Disinfectants USE Against Covid 19 Artg Legal Supply Australia
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Post Market Evaluation Serology Based Point Care Tests
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Other Resources Sponsors Listed Medicines AND Registered Complementary Medicines
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Regulation Stem Cell Treatments Information Practitioners
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Medicine Shortages Information Health Professionals
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Prescription Opioids What Changes ARE Being Made AND WHY
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Prescription Opioids Information Consumers Patients AND Carers
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Opioid Resources
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Database Consents Import Supply OR Export Therapeutic Goods DO NOT Comply TGO 91 DUE Covid 19
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Submissions Received Products Used AND People Disabilities
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TGA Laboratories What WE Test HOW WE Test AND What WE DO OUR Results
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Documents Released Under Section 11C Freedom Information ACT 1982 JUL 2019 JUN 2020
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Export Medicines
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Export Medical Devices
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Export Human Substances
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Face Masks AND Respirators WE Regulate
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Faecal Microbiota Transplant Products Regulation
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Submissions Received Draft Standards Faecal Microbiota Transplant FMT Products
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Information About Infringement Notices
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Disinfectant Information Consumers
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Medicinal Cannabis Access Pathways AND Usage Data
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Registered Medicines Cancellations Artg
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Vapes Information Individuals AND Patients
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Submissions Received AND Government Response Proposed Clarification Certain Sports Supplements ARE Therapeutic Goods
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Medicinal Cannabis Information Patients
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Medicinal Cannabis Information Health Professionals
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Medicinal Cannabis Information Importers Exporters AND Manufacturers
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Medicinal Cannabis News AND Updates
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Information Sponsors Supplying Medicines During Shortage Under Section 19A
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Submissions Received AND TGA Response Transparency Measures Prescription Medicines
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Information Australian Manufacturers Medicinal Cannabis Products
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Advertising Basics
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Advertising Investigation Outcomes
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Social Media Acceptable USE Policy
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Covid 19 Vaccine Approval Process
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Covid 19 Vaccine Information Consumers AND Health Professionals
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Covid 19 Vaccine Information Sponsors
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Covid 19 Vaccine International Collaboration
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Restricted AND Prohibited Representations Advertising
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Medical Devices Reforms Consumerpatient Information Materials Requirements
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Medical Device Reforms Comparable Overseas Regulator Marketing Approvals
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Medical Devices Reforms Enhancements Post Market Monitoring
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Medical Device Reforms Establishment UDI System
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Medical Devices Reforms Reclassification Surgical Mesh
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Medical Devices Reforms Mutual Recognition Agreements
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Medical Device Reforms Benchmarking Against International Assessment Timeframes
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Medical Devices Reforms Reclassification Certain Medical Devices
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Medical Devices Reforms Software Regulation
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Medical Devices Reforms IVD Companion Diagnostics
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Medical Devices Reforms Personalised Medical Devices
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Medical Devices Reforms LOW Risk Products
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Medical Devices Reforms Class I LOW Risk Medical Devices
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Medical Devices Reforms Other Therapeutic Goods LOW Risk Products
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Medical Devices Reforms Conformity Assessment Bodies
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Medical Devices Reforms Priority Review Pathway
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Medical Device Reforms Regulatory Changes
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Covid 19 Vaccines Regulatory Status
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Access Consortium Statement Covid 19 Vaccines Evidence
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Medical Devices Reforms Review Regulation Certain Self Testing Vitro Diagnostic Medical Devices Australia
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Tiwgg Meeting Summaries
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Technical Working Groups
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Ability Covid 19 Tests Detect Emerging Genetic Variants Sars COV 2
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Face Masks AND Covid 19
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Prescription Medicines Applications Under Evaluation
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Reporting Suspected Side Effects Associated Covid 19 Vaccine
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Covid 19 Vaccine Safety Monitoring AND Reporting
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Aust Numbers Medicine Labels
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Serialisation AND Data Matrix Codes Medicines
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Post Approval Changes Covid 19 Vaccines
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SME Guidance Material
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Australian Conformity Assessment Bodies Australian Cabs
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Unique Device Identification Consumers
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Unique Device Identification Healthcare Providers
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UDI Resources AND Technical Documents
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UDI News AND Updates
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Therapeutic Goods Custom Made Medical Devices Annual Reporting Form Approval 2021
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Updates Sunscreen Standard
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RE Classification Software Based Medical Devices
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Access Consortium Biosimilars Work Sharing Initiative
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Substituting Scarce Medicines
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Covid 19 Treatments Provisional Determinations
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Covid 19 Treatments Provisional Registrations
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Covid 19 Treatments Undergoing Evaluation
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Covid 19 Treatment Information Sponsors Industry
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Covid 19 Treatment Information Consumers AND Health Professionals
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Medicinal Cannabis Special Access Scheme Data
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Vapes Information Sponsors Importers AND Manufacturers
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Vapes News AND Updates
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Access Consortium Alignment Icmra Consensus Immunobridging Authorising NEW Covid 19 Vaccines
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Vapes Compliance AND Enforcement
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Data Protection Scheme Assessed Listed Medicines
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Covid 19 Vaccines NOT Registered Australia Current International USE TGA Advice Recognition
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Therapeutic Goods Medical Devices Application Form Inclusion Approval NO 2 2021
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Introduction Global Medical Device Nomenclature Gmdn
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Covid 19 Rapid Antigen Self Tests Home USE
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Covid 19 Point Care Tests
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QAS Covid 19 Rapid Antigen Self Tests
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Instructions Sponsors WHO Have Interest Supplying Covid 19 Self Test
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Covid 19 Rapid Antigen Self Tests ARE Approved Australia
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Patient Information Material Implantable Medical Devices
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Human Immunodeficiency Virus HIV Self Tests ARE Approved Australia
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Implementation Decisions AND Actions Following Review Chemical
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Applications AND Reporting Unapproved Medicinal Cannabis
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Accessing Medicinal Cannabis Patient
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Medicinal Cannabis Product List
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Resources Clinical Trials AND Clinical Evidence
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Clause Clause Tracking Tgo109 Sunsetting Standards
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Clause Clause Tracking Tgo108 NEW OLD
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Clause Clause Tracking Tgo107 NEW OLD
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Cracking Code Developing Requirements Data Matrix Codes Medicines 20 October 2021
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International Covid 19 Vaccines Recognised Australia
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Therapeutic Good Names Have Advertising Requirements
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Listed Medicines Requiring Pregnancy Warning Statement
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Listed Medicines Containing Caffeine
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List Ventilator Cpap AND Bipap Devices Unaffected Foam Material
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Software Based Medical Devices Faqs
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Access Consortium Statement Covid 19 Medicines
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Post Market Review Nucleic Acid Tests
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Post Market Review Antigen AND Rapid Antigen Tests
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Listed Aerosol Sunscreen Products
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Regulation Advanced Therapies
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Project Orbis
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Importing Covid 19 Rapid Antigen Tests Rats
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Obtaining Approved Covid 19 Rapid Antigen Tests
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Updates Legislative Instruments Exempting Monographs Standards
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Basics Medical Devices Regulations Recent AND Upcoming Regulatory Changes
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Independent Expert Report Risks Intentional Self Poisoning Paracetamol
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TGA Website Redevelopment 2022
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Find Information About Medical Device
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Buying Medicines AND Medical Devices Online
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Covid 19 Personal Protective Equipment
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Find Information About Medicine
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Reporting Adverse Events Consumers
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Reporting Adverse Events Health Professionals
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Reporting Adverse Events Industry
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Tampons AND Menstrual Cups
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Accessibility
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Import Advertising AND Supply Compliance Priorities 2023 25
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Supply Prescription Medicine
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Advertising Decision Trees
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Specialised Advertising Issues AND Topics
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Supply NON Prescription Medicine
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Annual Charge Exemption Scheme Forms
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Manufacture Medical Device
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Quality Safety AND Performance Requirements Medical Devices Essential Principles
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Personalised Medical Devices
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Personal Protective Equipment PPE
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System OR Procedure Packs
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First AID Kits
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Overview Regulatory Framework Ivds
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Australian Regulatory Evidence Options Medical Device Application
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Manufacturing Biologicals Blood AND Tissues AND Advanced Therapies
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Medicinal Cannabis Manufacturing
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Supply Medical Device
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Classification Medical Devices
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Priority Review Pathway Medical Devices
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Advertising Legal Framework