Resources
Regulator resource library
56,398 indexed Australian government compliance resources across 11 federal regulators.
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Checklist Prescribing Psychiatrists Mdma AND Psilocybine
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Calcium Fructoborate Tetrahydrate
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Cyclocarya Paliurus Leaf Extract DRY
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Withdraw Your Artg Application
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GMP Clearance Application AND Submission User Guide
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HOW Submit Custom Made Medical Device Notification
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Notification Carry OUT Steps Manufacture Therapeutic Vaping Goods
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Notice Import Cannabis Vaping Devices
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Clinical Trial Significant Safety Issueurgent Safety Measure Safety Reporting Form Ssiusm
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Theanine
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Standards Therapeutic Vaping Devices Checklist
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Clinical Trial Notification CTN Form User Guide
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Application Australian Conformity Assessment Body Determination
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Note Guidance Maximum Shelf Life Sterile Products Human USE After First Opening OR Following Reconstitution
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Bacillus Subtilis Strain Nrrl B 67989
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D Glucose Polymer Xylitol
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Influenza Reagents Order Form
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ICH M9 Guideline Biopharmaceutics Classification System Based Biowaivers
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ICH Harmonised Guideline Nonclinical Safety Testing Support Development Paediatric Pharmaceuticals
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ICH E11r1 Guideline Clinical Investigation Medicinal Products Pediatric Population
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ICH Guideline S1br1 Testing Carcinogenicity Pharmaceuticals
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Cancer Clinical Trial Eligibility Criteria Patients Organ Dysfunction OR Prior OR Concurrent Malignancies
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ICH Electronic Common Technical Document Ectd V40
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ICH Guideline E8 R1 General Considerations Clinical Studies
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ICH Guideline Q3C R8 Impurities Guideline Residual Solvents
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ICH M7r2 Guideline Assessment AND Control DNA Reactive Mutagenic Impurities Pharmaceuticals Limit Potential Carcinogenic Risk
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ICH M7r2 Addendum Application Principles ICH M7 Guideline Calculation Compound Specific Acceptable Intakes
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ICH Guideline M10 Bioanalytical Method Validation AND Study Sample Analysis
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ICH Guideline Q3D R2 Elemental Impurities
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Ectd AU Module 1 AND Regional Information V32
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Integrated Addendum ICH E6r1 Guideline Good Clinical Practice E6r2
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Akkermansia Muciniphila Strain Atcc BAA 835
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ICH Topic M4S Common Technical Document Registration Pharmaceuticals Human USE Safety
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Guideline Pharmaceutical Quality Inhalation AND Nasal Products
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Finished Product Medicine Analytical Procedure Validations Complementary Medicines
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Information Quality Medicinefinished Product
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Sponsor Notice Therapeutic Vaping Goods
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Ectd V40 AU Module 1 AND Regional Information
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Annex 1 WHO Guidelines Nonclinical Evaluation Vaccines
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Annex 2 Guidelines NON Clinical Evaluation Vaccine Adjuvants AND Adjuvanted Vaccines TRS NO 987
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Bioequivalence Immediate Release Solid Oral Dosage Forms M13a
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European Union Guidelines Herbal Medicinal Products
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Quality Working Party Questions AND Answers API MIX
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Guideline Good Pharmacovigilance Practices GVP Module VI Collection Management AND Submission Reports Suspected Adverse Reactions Medicinal Products REV 2
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Guideline Good Pharmacovigilance Practices GVP Module Viii Post Authorisation Safety Studies REV 3
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Guideline Clinical Evaluation Anticancer Medicinal Products
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Guideline Assessment Clinical Safety AND Efficacy Preparation EU Herbal Monographs Well Established AND Traditional Herbal Medicinal Products
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Guideline Control Impurities Pharmacopoeial Substances Compliance European Pharmacopoeia General Monograph Substances Pharmaceutical USE AND General Chapter Control Impurities 0
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Appendices Guideline Epidemiological Data Blood Transmissible Infections 0
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Guideline Epidemiological Data Blood Transmissible Infections 0
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Data Standards Drug AND Biological Product Submissions Containing Real World Data Guidance Industry
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Aliskiren Film Coated Tablet 150 MG AND 300 MG Product Specific Bioequivalence Guidance 0
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Apixaban Film Coated Tablet 25 AND 5 MG Product Specific Bioequivalence Guidance 0
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Drug Interaction Studies M12
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Nonclinical Biodistribution Considerations Gene Therapy Products S12
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ICH Q5ar2 Guideline Viral Safety Evaluation Biotechnology Products Derived Cell Lines Human OR Animal Origin
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Guideline Chemistry Active Substances
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Methoxypropylamino Cyclohexenylidene Ethoxyethylcyanoacetate
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Transition NEW GMP Requirements Medicinal Products
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ICH E9 R1 Addendum Estimands AND Sensitivity Analysis Clinical Trials Guideline Statistical Principles Clinical Trials
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Guideline Quality Documentation Medicinal Products When Used Medical Device
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Guideline Good Pharmacovigilance Practices GVP Module I Pharmacovigilance Systems AND Their Quality Systems
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Pediococcus Pentosaceus Cect 8330
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Urolithin
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Appendix TMF Submission Form
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Artg Advanced Search Visualisation Tool
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Request Information Relating Supply Therapeutic Vaping Goods
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Lauryl Methacrylatesodium Methacrylate Crosspolymer Dispersion 40 Cent
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Sorbitan Distearate
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Stearoyl Glutamic Acid
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Nicotinamide Mononucleotide
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ICH E6r3 Guideline Good Clinical Practice
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Preparing UDI AND Ausudid Checklist
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Note Guidance Specifications Test Procedures AND Acceptance Criteria Herbal Drugs Herbal Drug Preparations AND Herbal Medicinal Products
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C1 Application Over Counter OTC Medicines Checklist
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Note Guidance Quality Herbal Medicinal Products
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Note Guidance Clinical Requirements Locally Applied Locally Acting Products Containing Known Constituents 0
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Guideline Equivalence Studies Demonstration Therapeutic Equivalence Locally Applied Locally Acting Products Gastrointestinal Tract 0
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Submitting SIX Monthly Reports Authorised Prescribers
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Instructions Completing Statutory Declaration Regarding 381g
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Accessing Ausudid
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Submitting UDI Records Using Australian UDI Bulk Upload Template
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Managing UDI Records Multiple Sponsors
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Searching Viewing AND Downloading UDI Records Ausudid
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Submitting UDI Records Using Ausudid Portal
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Navigating Listed Medicines Framework
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Completing Application Consent Import Supply OR Export Medical Devices DO NOT Meet UDI Related Essential Principles
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Checklists
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Forms
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Compositional Guidelines
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International Scientific Guidelines Adopted Australia
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User Guide
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Therapeutic Goods Administration TGA
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About US
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TGA Business Services TBS
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Decision Trees
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TGA Learn
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Using OUR Website
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Consumer Information AND Resources
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Report Problem
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Adverse Events
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Medicine Adverse Events
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Medical Device Adverse Events
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Medicine Shortages
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Medical Device Supply Disruptions
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Business Services
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Regulations ALL Products
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Special Access Scheme AND Authorised Prescriber Online System
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About Australian Register Therapeutic Goods Artg
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Explore Topic
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Recalls AND Other Market Actions
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Quick Links
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Make Advertising Enquiry
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Report NON Compliant Advertising
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Medicines Pregnancy Current Database WEB
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Prescribing Medicines Pregnancy Database
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Withdrawn OR Ceased Sponsor Notices
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Search Notified Vape List
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Testing Results
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Advertising
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Committees AND Advisory Bodies
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Clinical Trials
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Cosmetics
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Covid 19
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Medicinal Cannabis HUB
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Safety Monitoring AND Information
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Scheduling National Classification System
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Shortages AND Supply Disruptions
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Sunscreens
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Unique Device Identification UDI HUB
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Import AND Export
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Metal Metal HIP Replacement Implants HUB
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Breast Implant HUB
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Urogynaecological Transvaginal Surgical Mesh HUB
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Vaping HUB
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Prescription Opioids HUB
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Compliance AND Enforcement
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Weight Loss Products
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Biologicals
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Medical Devices
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Medicines
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Other Therapeutic Good
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Unapproved Therapeutic Goods
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Faecal Microbiota Transplant Products
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Human Cell AND Tissue Products
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Implantable Devices
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Vitro Diagnostic Devices
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Personalised Medical Devices
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Personal Protective Equipment
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System AND Procedure Packs
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Assessed Listed Medicines
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Listed Medicines
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Over Counter Medicines
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Prescription Medicines
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Registered Complementary Medicines
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Therapeutic Sunscreens
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Mdma AND Psilocybine
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Medicinal Cannabis
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Therapeutic Vaping Goods
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Disinfectants AND Sterilants
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Tampons AND Menstrual Cups
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Boundary Combination
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Software AND Artificial Intelligence AI