Resources
Regulator resource library
56,398 indexed Australian government compliance resources across 11 federal regulators.
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Frequently Asked Questions Medical Device Single Audit Program Mdsap
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Therapeutic Goods TGA Assessed Claim Authorisation 2020
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Systems ARE Medical Devices
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HOW USE Sunscreens
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Reading Sunscreen Labels
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Changes Regulation Vapes
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Therapeutic Goods Legislation Amendment 2023 Measures NO 2 Regulations 2023
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GMP Clearance Sponsor Information Dashboard SID
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Medical Device Cyber Security Consumer Information
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Medicinal Cannabis Vaping Devices Information Importers Exporters AND Manufacturers
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Roles AND Responsibilities Clinical Trial Safety Reporting Significant Safety Issues AND Urgent Safety Measures
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UDI Information Sponsors AND Manufacturers
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Ingredient Basics
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Request NEW Ingredient
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Naming Ingredients
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Naming Convention Chemical Substances
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Supporting References Approved Ingredient Names
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Complete Approved Herbal Names
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Searching Ingredient Requirements
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Ingredient Naming Requirements AND Categorisation
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Vapes Information Retailers
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Nicotine Pouches
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UDI Acronyms AND Glossary
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About Shortage Transdermal HRT Patches
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Post Market Review Plastic Syringes
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Scope UDI Requirements
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UDI Labelling AND Packaging Requirements
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UDI AND Other TGA Processes OR Activities
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Australian UDI Database Sponsors AND Manufacturers
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UDI Webinars
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Australian UDI Database PRE Production Environment Release Notes
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Australian UDI Bulk Upload Template
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Australian UDI Data Dictionary
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Advertising Health Services AND Cosmetic Injections Frequently Asked Questions AND Answers
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Overview UDI Australian Healthcare
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UDI Consultations AND Forums
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Artificial Intelligence AI AND Medical Device Software Regulation
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Investigators Brochures Medical Device Clinical Trials
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Learn About Vitro Diagnostic IVD Medical Devices
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Vapes Information Wholesale Transport Logistics AND Storage Facilities
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Steps Supply Device Sponsors
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Steps Supply Device Manufacturers
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Vapes Information Prescribers
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Vapes Information Pharmacists
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About Shortage Intravenous IV Fluids
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Technical Reference Group Software Medical Device Samd AND Artificial Intelligence AI
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Medicine Shortages Data Sharing Framework
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Data Sharing Help Manage Serious Shortages Hospital Medicines
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Review Clinical Trial Approval CTA Scheme
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Post Market Review Neonatal Incubators
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Prescribing AND Dispensing Prescription Only Therapeutic Vaping Goods Patients Under 18 Years AGE
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About Changes Supply Insulin Products
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Quality Management System Audits AND Nonconformities
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Notified Vape List Goods Smoking Cessation OR Nicotine Dependence
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Vapes Advertising AND Promotion
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Applying Advertising Code
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Improvements Managing Medicine Shortages AND Discontinuations
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Test Method Uplcc01 Cannabinoids
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HOW Obtain GMP Clearance Through Inspection Reliance
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Sponsor Responsibilities Related GMP Clearance AND Certification
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About Shortage Bicillin L Benzathine Benzylpenicillin Tetrahydrate Prefilled Syringe Injection
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Post Market Review Energy Based Devices Used Vaginal Rejuvenation
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About Shortage Methylphenidate Hydrochloride Products
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Listed Medicines Containing Valeriana Officinalis Requiring Warning Statements
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Therapeutic Goods Legislation Amendment 2024 Measures NO 3 Regulations 2024
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EU Ivdr Transition Extension
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Information About TGA Laboratory Testing Results
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Testing Biological Medicines
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Established Acceptable Intake Other Nitroso Structures Medicines
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Stability Requirements Listed Medicines
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Medicinal Cannabis Vaping Devices ARE Approved Australia
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Section 22 Instruments
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Human Placenta Ingestion
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Submitting Applications Extension Indications Align Reference Product
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Updates Variations Prescription Medicines Guidance AND E Form
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Pathways Supply Biologicals
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Breast Implant Associated Cancer Information Health Professionals
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Breast Implants Things Consider
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Guidance USE Medicinal Cannabis Australia Overview
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Guidance USE Medicinal Cannabis Prevention OR Management Nausea AND Vomiting Australia
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Guidance USE Medicinal Cannabis Treatment Chronic NON Cancer Pain Australia
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Guidance USE Medicinal Cannabis Treatment Palliative Care Patients Australia
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Guidance USE Medicinal Cannabis Treatment Epilepsy Paediatric AND Young Adult Patients Australia
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Guidance USE Medicinal Cannabis Treatment Multiple Sclerosis Australia
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Guidance USE Medicinal Cannabis Australia Patient Information
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Annual Charge Exemption Scheme Frequently Asked Questions
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Understand Annual Charge Exemption Scheme
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Code Practice Tamper Evident Packaging Therapeutic Goods
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Modified Release Paracetamol
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Labels Covid 19 Vaccines
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Labels Covid 19 Treatments
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Prescription Opioids Information Health Professionals
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Opioid Reforms Information Sponsors
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Guidance USE Vapes Smoking Cessation OR Management Nicotine Dependence
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HOW WE Manage Your Medical Device Adverse Event Report
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Opioids Boxed Warning AND Class Statements
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HIV Testing Australia
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HIV Point Care Tests Conditions Approval Supply Australia
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OUR Risk Management Approach
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Medicine Shortages Information Sponsors
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Good Clinical Practice GCP Inspection Program
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Australian UDI Database
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Ahmac Scheduling Policy Framework Medicines AND Chemicals
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Metal Metal HIP Replacement Implant Health Professionals
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Metal Metal HIP Implant Information Patients
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Covid 19 Rapid Antigen Tests Information Manufacturers AND Sponsors
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Streamlining Proprietary Ingredient Categories
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Discontinuing PRE Market Evaluation Herbal Component Names Frequently
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SAS AND AP Categories Medicinal Cannabis Products
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Black Triangle Scheme Information Sponsors
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Procedure Recalls Product Alerts AND Product Corrections Prac
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Serious Scarcity Substitution Instruments Sssis
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Advertising Personalised Medical Devices
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Claim TGA Approved Must NOT BE Used Advertising
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What CAN AND Cannot BE Advertised General Public
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Advertising Compliance AND Reports
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Requirements Weight Management Claims Advertising
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General Requirements Advertising Therapeutic Goods Public
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Mandatory Statements AND Other Information Required Advertising
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Rules Giving Samples AND Incentives Advertise Therapeutic Goods
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Advertising Price Lists Pharmacy AND Prescription Only Medicines
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Using Scientific OR Clinical Representations Advertising
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Testimonials AND Endorsements Advertising
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Using Natural Claims Therapeutic Goods Advertising
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Advertising Covid 19 Rapid Antigen Tests
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Clinical Trials Webinars Presentations AND Consultations
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HOW WE Regulate Australian Clinical Trials USE Unapproved Therapeutic Goods
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Clinical Trial Notification CTN Scheme
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Australian Clinical Trial Reforms
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Case Studies
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Australian UDI Database Production Environment Release Notes
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Sponsor AND Manufacturer Obligations Meeting UDI Requirements
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Overview Compositional Guidelines AND Templates
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Sunscreen Regulation Australia
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Pharmacovigilance Obligations Medicine Sponsors Frequently Asked Questions
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UDI Requirements Specific Device Types
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Listed Medicines Containing Fennel Requiring Warning Statements
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Hand Sanitiser Information Consumers
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Marketing Complementary Medicines Soft GEL Capsules Children
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Over Counter OTC Medicine Monographs N2 Applications
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Inspections AND Inspectors Complaint Process
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Disinfectant Information NEW Sponsors
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Identification Herbal Materials AND Extracts
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PRE Submission Meetings TGA
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Regulatory Affairs Consultants
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Regulation Cleaners AND Disinfectants
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Appropriate USE Disinfectants
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Prescription Medicines Overview
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Listed Medicines Using Indications Related Diarrhoea Requiring Warning Statement
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Cosmetic Injections Tips Help YOU Make Informed Decision
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Australian Regulatory Guidelines Args
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Australian Regulatory Guidelines Medical Devices Argmd
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Australian Regulatory Guidelines Biologicals Argb
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Australian Regulatory Guidelines OTC Medicines Argom
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Australian Regulatory Guidelines Prescription Medicines Argpm
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Australian Regulatory Guidelines Registered Complementary Medicines Argrcm
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Medical Device Cyber Security
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Breast Implant Illness
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Medical Device Cyber Security Information Users
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Medical Dictionary Regulatory Activities Meddra
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Listed Medicines Training
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Medicines Repurposing Program Program Outcomes AND Changes
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Proposing NEW Ingredient Name
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Sunscreen Ingredients
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HOW Search Database Adverse Event Notifications Daen Medicines
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Prescription Medicine Clinical Units
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Submit Drug Master File DMF
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Medical Practitioners Guide Classifying Surgical Mesh
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Personal Protective Equipment Health Professionals
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Disinfectant Claim Guide Specific Claims AND NON Specific Claims
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IVD Sponsors Roadmap Market
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Evidence Requirements Face Masks ARE Medical Devices
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TGA Business Services Getting Started TGA
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Evaluation Plan Estimators
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Medical Device Production Systems
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Code Tables
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Access Consortium NEW Active Substance NAS Work Sharing Initiative Questions AND Answers QA
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Auspars Questions AND Answers
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Tgas Approach Delays Medical Device Conformity Assessment
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Introduction External Clinical Evaluators
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TGA Regulatory Compliance
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TGA Approves Reduction Deferral Period Blood AND Plasma Donors
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Infographic Become Authorised Prescriber Nicotine Vaping Products
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Changes Regulation Sports Supplements Australia
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MY Software Regulated
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Specimen Collection Swabs
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Approval PI Form
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Form Providing Product Information
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Colourings Used Medicines Topical AND Oral USE
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Nees AU
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Questions AND Answers Relating Additional Default Standards Legislation
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Listed Medicines Risk Containing Safrole
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Stability Testing Listed Complementary Medicines
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Analytical Procedure Validation Complementary Medicines
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Evidence GMP Prescription Medicines
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Starting Material Analytical Procedure Validation Complementary Medicines
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Standards Applying Therapeutic Goods Information Consumers
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TGA KEY Performance Indicators AND Measures Regulator Performance Framework
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Permitted Indications Listed Medicines
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TGA Laboratories Testing Ranitidine Medicines