Resources
Regulator resource library
56,398 indexed Australian government compliance resources across 11 federal regulators.
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Therapeutic Goods Orders
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Section 9D Instruments
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Section 23 Instruments
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Labelling AND Packaging
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Medicines Safety Monitoring
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E2B Reports Frequently Asked Questions
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Prescription Medicines
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Prescription Medicines Regulation Basics
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Australian Regulation Prescription Medical Products
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Standards AND Guidelines Prescription Medicines
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Dossier Documents Matrix Module 1
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Dossier Documents Matrix Module 2 5
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Regulatory Decisions AND Notices Prescription Medicines
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About Australian Public Assessment Reports Prescription Medicines Auspars
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Australian Regulation Over Counter Medicines
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OTC Medicine Monograph Ibuprofen Oral USE
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Target Evaluation Times Over Counter OTC Medicine Applications
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Listed Complementary Medicines
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Registered Complementary Medicines
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KEY Regulatory Guidance Materials
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Medical Devices AND Ivds Contacts
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Medical Devices Regulation Basics
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Vitro Diagnostic IVD Medical Devices
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Regulation Nutrigenetic Tests
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Standards Guidelines AND Publications Medical Devices AND Ivds
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IVD Guidance Documents
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Regulatory Decisions AND Notices Medical Devices AND Ivds
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Blood AND Blood Components
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Regulation Blood
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Forms Blood AND Blood Components Industry
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Regulatory Framework Biologicals
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Biological Standards
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Forms Biologicals Industry
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Manufacturing Basics Medicines AND Biologicals
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Manufacture Therapeutic Goods
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Good Manufacturing Practice Overview
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Manufacturer Inspections Overview
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Manufacturer GMP Inspection Typical Example
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Manufacturer Inspections Using Risk Based Approach Frequency
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Manufacturer Inspections Productprocess Risk Classifications
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Manufacturer GMP Compliance History
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Manufacturing Medicines
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Manufacturing Medical Devices AND Ivds
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Manufacturing Medical Devices AND Where Start
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Manufacturing Blood AND Blood Components
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Forms Manufacturers
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Notices Manufacturers
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Scheduling Medicines Poisons
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Scheduling Basics Medicines AND Chemicals Australia
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Public Notices About Scheduling
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Stateterritory Scheduling Information
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Contacts Stateterritory Medicines Poisons Regulation Units
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Australian State Territory Regulatory Controls Schedule 7 Poisons
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Email Subscriptions
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RSS Feeds
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Doing Business US
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Safety Information
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Database Recalls Product Alerts AND Product Corrections Drac
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Database Recalls Product Alerts AND Product Corrections Drac Questions AND Answers
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Report Adverse Event OR Safety Problem
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Medicine Monitoring Guidelines AND Safety Reviews
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Database Adverse Event Notifications Daen
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About Database Adverse Event Notifications Daen Medicines
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Error 404 Page NOT Found
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Australian Influenza Vaccine Committee Aivc Terms Reference
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Information About Cancellations Requested Sponsor Regulatory Actions
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OTC Medicine Monograph Mebendazole
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Medical Device AND IVD Suspensions Artg
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Scheduling Committees Meeting Dates AND Decisions Timeframes
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Cancellations
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Suspensions
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Regulatory Decisions AND Notices
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Changes Sponsorship Therapeutic Goods
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NEW TGA Business Services Site
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TGA Business Services TBS Terms AND Conditions
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Application Instructions Conformity Assessment Certification
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Submissions Received Regulation Autologous Stem Cell Therapies
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TGA Business Services HOW USE Portal
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TGA Business Services Drafter AND Submitter Roles Presentation
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Prescription Medicines Registration NEW Chemical Entities Australia
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Medical Device AND IVD Cancellations Requested Sponsor Certain Devices Within Entry
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Annual Charge Exemption ACE Scheme Entries Have Generated Turnover
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Failure PAY Annual Charges Manufacturing Licences Revoked
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OTC Medicine Monograph Hand Sanitisers
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Updating Medicine Ingredient Names List Affected Ingredients
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Overview Over Counter OTC Medicine Registration
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Social Media
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Manufacturing Biologicals
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Consent Import Supply OR Export Therapeutic Goods DO NOT Comply Standards Information Industry
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Consent Import Supply OR Export Goods DO NOT Comply Standards
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About Consultations
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Changes Adrenaline AND Noradrenaline Labels
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Acss Public Statement 30 31 October 2015
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Prescription Medicines NEW OR Extended Uses OR NEW Combinations Registered Medicines
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Updating Medicine Ingredient Names Information Sponsors
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Legal Basis Using Approved Terminology
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Other Terminology
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Recall Coordinators Therapeutic Goods
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Australias Medicine Labels ARE Becoming Clearer
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Labelling Requirements Information Sponsors
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Class 4 House Ivds Using Online Application AND Notification Forms
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Section 7C Instruments
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Annual Performance Statistics Reports
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Listed Medicines ARE Required BE Tested Presence Aristolochic Acids
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Listed Medicines Blood Glucose AND Cholesterol Indications
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Oral Probiotics Indicated Vaginal Conditions
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Medicinal Cannabis Guidance Documents
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Access Medicinal Cannabis Products Frequently Asked Questions Faqs
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Class 1 3 House Ivds Using Online Application Form
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Folate AND Folic Acid USE Listed Medicines
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Documents Released Under Section 11C Freedom Information ACT 1982 JUL 2015 JUN 2016
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Clinical Evidence Guidelines Documents Medical Devices
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NEW Biologicals Based Parent Biological
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Data Management AND Data Integrity Dmdi
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SME Assist
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Regulation Essentials
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Overview Applying Market Authorisation
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Overview Medical Devices AND IVD Regulation
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Notifications Process Registered Medicines
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Useful Resources Business AND Researchers
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Listed Medicines Referencing Macular Degeneration
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Conformity Assessment Overview
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Variations Prescription Medicines Excluding Variations Requiring Evaluation Clinical OR Bioequivalence
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Reinstatement Entry Artg
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Regulation Live Animal Cells Tissue AND Organs
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Criteria Permitted Indications Fact Sheet
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Medicinal Cannabis Importation AND Travellers Exemption
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Chronic Pain Management Video Resource Brainman
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Responsibilities Manufacturers Medicines AND Biologicals
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Target Timeframes Manufacturing Inspections
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Suspending Revoking AND TGA Initiated Variation Conditions Manufacturing Licence
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Transfer Manufacturing Licence
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GMP Deficiencies
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Declaration Intent Supply Australian Market
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Requesting Variations Your Manufacturing Licence
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Documents Released Under Section 11C Freedom Information ACT 1982 JUL 2016 JUN 2017
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Pharmacovigilance Inspection Program
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International Agreements AND Arrangements GMP Clearance
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Epilepsy Randomised Controlled Trials AND Other Studies
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Multiple Sclerosis Randomised Controlled Trials AND Other Studies
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Nausea AND Vomiting Randomised Controlled Trials AND Other Studies
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Tips Talking About Codeine Guidance Health Professionals Prescribing Authority
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Tips Talking About Codeine Guidance Pharmacists
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Tips Talking About Codeine Guidance Pharmacy Assistants
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Terms Reference Access Consortium
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Pain Randomised Controlled Trials AND Other Studies
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Palliation Randomised Controlled Trials AND Other Studies
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Accessing Medicines During Shortage
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Black Triangle Scheme Format AND Examples
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Prescription Medicines Variation E Form Frequently Asked Questions Faqs
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Principles Terminology Used Permitted Indications
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Using Permitted Indications
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Submissions Received TGA Enhancing Sanctions AND Penalties Therapeutic Goods ACT 1989
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Advertising Codeine General Public Prohibited
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Codeine USE CAN BE Harmful
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Codeine Advice AND Support IF YOU Have Chronic Pain
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National Codeine Communication Strategy
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Codeine Education Resources Health Professionals
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Codeine Harm AND Efficacy Literature
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OUR Business Plans
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What CAN Pharmacy Assistants SAY Customers About Specific Pain Relief Products
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Guidance Materials Permitted Indications Listed Medicines
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List Countries AND Jurisdictions Determined BE Comparable Overseas
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Comparable Overseas Regulators Cors Submission Requirements
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Acss Public Statement 2 3 June 2017
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Submissions Received AND TGA Response Nomenclature Biological Medicines
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Prescription Medicines AND Biologicals NEW Registrations
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Submissions Received Therapeutic Goods Advertising Code
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About Database Section 19A Approvals Import AND Supply Medicines Address Medicine Shortages
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Physiotherapist Fact Sheet Talking People About Changes Codeine Access
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Assessed Listed Medicines Pathway Complementary Medicines
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Three Tiered Risk Based Framework Complementary Medicines
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Assessed Listed Medicines Pathway Frequently Asked Questions
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Access Consortium NEW Active Substance NAS Work Sharing Initiative
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Regulatory Decisions AND Notices Biologicals
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Submissions Received AND Next Steps Prescription Strong Schedule 8 Opioid USE AND Misuse Australia Options Regulatory Response
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Acss Public Statement 27 28 October 2017
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Submissions Received Options Future Regulation LOW Risk Products
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Future Regulation LOW Risk Products
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Argb Quick Links
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Biologicals Regulation
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Supplying Biologicals
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Guidance Biological Standards
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Documents Released Under Section 11C Freedom Information ACT 1982 JUL 2017 JUN 2018
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Submissions Received Discontinuing PRE Market Evaluation Herbal Component Names Hcns
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TGA Facebook Launch Media KIT
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Section 7AA Instruments
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Advertising Directions AND Prevention Notices
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Mandate Access Consortium Generic Medicines Working Group
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Submissions Received AND High Level Summary Boxed Warning Guidance
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Memorandum Understanding Between Philips Electronics Australia AND Therapeutic Goods Administration
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Breast Implant Associated Cancer Consumer Information
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Medical Devices Overview
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Medicine Shortages Information Consumers
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Video About Therapeutic Goods Administration
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Prescription Medicines Registration
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Influenza Reagents
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Therapeutic Goods Medicine Shortages AND Discontinuations Notification Forms Approval 2023
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Instruments
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Vaccines Overview