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Contact TGA: info@tga.gov.au | 1800 020 653 | More contact info Translate | Subscribe Therapeutic Goods Administration (TGA) Australian Government Department of Health Main menu Home Safety informationReport a problem or side effectReporting adverse events involving medicines, vaccines or medical devices Report an issue with packaging or storage of a medicine AEMS guidance for health professionals AEMS guidance for sponsors Help us promote adverse event reporting: promotional resources kit AlertsCurrent year alerts All alerts RecallsAbout Australian recall actions Recall actions database Uniform recall procedure Prescription opioids Medicine shortages Early warning systemMonitoring communications About the Early Warning System Early Warning System: consumer questions and answers Early Warning System: health professional questions and answers Black Triangle SchemeBlack Triangle Scheme: Information for sponsors Safety information & educationMedicines safety Medical devices safety Database of Adverse Event Notifications (DAEN) COVID-19 COVID-19 vaccinesCOVID-19 vaccine approval process COVID-19 vaccines undergoing evaluation Provisional registrations COVID-19 vaccine safety monitoring and reporting News and updates COVID-19 vaccine advertising and import compliance Information for consumers and health professionals Information for sponsors (industry) International collaboration International COVID-19 vaccines recognised by Australia COVID-19 treatmentsCOVID-19 treatment: Celltrion Healthcare Australia Pty Ltd, regdanvimab (REGKIRONA) COVID-19 treatment: Roche Products Pty Ltd, tocilizumab (ACTEMRA) COVID-19 treatments: Provisional determinations COVID-19 treatments: Provisional registrations COVID-19 treatments: Treatments undergoing evaluation COVID-19 treatments: Advertising compliance COVID-19 treatments: Information for consumers and health professionals COVID-19 treatments: Information for sponsors (industry) COVID-19 testsHow testing works for COVID-19 COVID-19 point-of-care tests COVID-19 rapid antigen self-tests COVID-19 rapid antigen tests - information for manufacturers and sponsors COVID-19 testing in Australia - information for health professionals Advertising COVID-19 rapid antigen point-of-care tests and self-tests (home use tests) Post market review of COVID-19 point-of-care tests ConsumersReport a problem or side effectReporting adverse events involving medicines, vaccines or medical devices Travelling with medicines and medical devicesLeaving Australia Entering Australia Helpful links for travellers Buying medicines and medical devices onlineCounterfeit medicines and devices Can I import it?Personal importation scheme Medicinal cannabis: importation and the traveller's exemption MedicinesHow we regulate medicines Prescription medicines Complementary medicines Over-the-counter (OTC) medicines Vaccines What's on my medicine label? 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Medical devicesMedical devices overview Transvaginal (urogynaecological) surgical mesh hub Breast implant hub Cosmetic injections Medical device cyber security Advertising hub Consumer information & educationSafety information for consumers Medicines & medical devices Community Q&A MedSearch | Medicine information search app Other web resources for consumers Medicinal cannabis products Health professionalsReport a problem or side effectReporting adverse events involving medicines, vaccines or medical devices Accessing unapproved productsSpecial access scheme Authorised prescribers Clinical trials Personal importation scheme Medicine shortages: Information for Health Professionals Accessing medicines during a medicine shortage Medicinal cannabis Nicotine vaping products Advertising MedicinesLabelling changes: information for health professionals Registration of medicines for the medical termination of early pregnancy Product Information Prescribing medicines in pregnancy database Medicine Shortages Information Initiative Fast track approval pathways for prescription medicines Medical devicesBreast implant associated-anaplastic large cell lymphoma (BIA-ALCL) Breast implant hub Changes to labelling and regulation of hard surface disinfectants (commencing 1 April 2019) Information for medical practitioners on pending up-classification of surgical mesh devices Patient information material for implantable medical devices Importing & supplying medical devices Advice about medical devices for health professionals BiologicalsRegulation of stem cell treatments: information for practitioners Safety informationMedicines Safety Update Medical Devices Safety Update Australian Adverse Drug Reactions Bulletin Medical device incident reporting & investigation scheme (IRIS) articles Implanting medical devices Other resources Health professional information & educationHealth professional educational materials IndustrySME AssistRegulation essentials Workshops and events Podcasts SME guidance material Educational videos Interactive decision tools Case studies Useful resources for business Understanding ingredient requirements Regulation basicsHow therapeutic goods are regulated in Australia Australian Register of Therapeutic Goods Industry educational materials Legislation & legislative instruments Advertising hub Labelling & packaging Ingredients in therapeutic goods Exporting therapeutic goods Importing therapeutic goods Clinical trials Cosmetics International scientific guidelines Safety information for industry Medicine shortages Review of real world evidence and patient reported outcomes Advertising therapeutic goodsGetting started Complying with advertising requirements Learning resources Enforcement and outcomes News and reports Consultation and independent reviews Prescription medicinesAustralian Regulatory Guidelines for Prescription Medicines Prescription medicines regulation basics Standards and guidelines Forms for prescription medicine sponsors Regulatory decisions and notices Over-the-counter medicinesOTC medicines regulation basics Standards, guidelines and publications Forms for OTC medicine sponsors Regulatory decisions and notices Complementary medicinesComplementary medicine regulation basics Standards, guidelines and publications Forms for complementary medicine sponsors Complementary medicines reforms Regulatory decisions and notices SunscreensSunscreens regulation basics Standards, guidelines and publications Sunscreen reforms Medical devices & IVDsAustralian conformity assessment bodies Conformity assessment certificates, changes to requirements for certain medical devices Consent for Non-compliant Medical Device(s) - Frequently Asked Questions Determinations for Australian conformity assessment bodies Face masks and COVID-19 Medical devices regulation basics Overview of medical devices and IVD regulation Unique Device Identification system IVD medical devices regulation basics Standards, guidelines and publications Forms for medical device & IVD sponsors Medical devices reforms Regulatory decisions and notices BiologicalsAustralian Regulatory Guidelines for Biologicals Regulatory framework for biologicals Biological standards Forms for the biologicals industry Regulatory decisions and notices Blood and blood componentsRegulation of blood Regulation of platelet-rich plasma (PRP), platelet-rich fibrin (PRF) and conditioned serum Forms for the blood and blood components industry Other therapeutic goodsDisinfectants, sterilants and sanitary products Tampons & menstrual cups Manufacturing therapeutic goodsManufacturing basics Manufacturing medicines Manufacturing medical devices & IVDs Manufacturing biologicals Manufacturing blood and blood components Manufacturing inspections Forms for manufacturers Notices for manufacturers Notices about GMP clearance Guidance on the management of GMP compliance signals Scheduling of medicines & poisonsScheduling basics Scheduling committees meeting dates and decisions timeframes The Poisons Standard (the SUSMP) Public notices about scheduling State/Territory scheduling information About the TGATGA basicsWho we are & what we do What the TGA doesn't do Structure TGA plans & reports TGA reforms Publications Forms Freedom of information Acronyms & glossary TGA Internet site Social media Contact the TGAHow can we help? 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These are aimed at consumers, health professionals or people working in the medical device or medicines industries. The links below are categorised by topic. This list is also available in an A-Z list. Advertising Advisory bodies/Committees Australian Register of Therapeutic Goods (ARTG) Biologicals Blood and blood components Clinical trials Complementary medicines Disinfectants/Sterilants Electronic submissions Fees/Payments Import/Export Labelling/Packaging Legislation Manufacturing Medical devices/IVDs Medicinal cannabis Medicines Medicines safety OTC medicines Other therapeutic goods Prescription medicines Regulatory compliance Safety of medicines & medical devices Scheduling Shortages Sunscreens Therapeutic Goods Administration (TGA) Unapproved therapeutic goods Advisory bodies/Committees Conflicts of interest and confidentiality obligations Labelling/Packaging Code of practice for tamper-evident packaging of therapeutic goods Regulation impact statement: International harmonisation of ingredient names Required Advisory Statements for Medicine Labels (RASML) Import/Export Export of human substances Fees/Payments ACE scheme waiver guidance Legislation Guidance for TGO 101 Medical devices/IVDs Advice for health procurement teams about therapeutic goods and medical devices An Action Plan for Medical Devices Application audit (technical file review) of IVD medical device applications Australian regulatory guidelines for medical devices (ARGMD) Classification of IVD medical devices Clinical evidence guidelines supplement: In vitro diagnostic (IVD) medical devices Clinical performance requirements and risk mitigation strategies for HIV tests Conformity assessment overview (IVDs) Conformity assessment procedures for immunohaematology reagents COVID-19 Rapid antigen self-tests Defining joint replacement medical devices and ancillary medical devices Device-medicine boundary products Electronic Instructions for Use - eIFU General dossier requirements Guidance on medical/surgical face masks and respirator standards - key performance aspects IMDRF Table of Contents pilot: TGA regional assembly and technical guide Including IVD medical devices in the ARTG IVD companion diagnostics Medical device cyber security guidance for industry Medical device cyber security information for users Medical device incident reporting (MDIR) guide Medical device inclusion process Personalised medical devices (including 3D-printed devices) Pre-submission meetings with TGA Priority review designations medical devices (including IVDs) Reclassification of surgical mesh devices Reduction of assessment fees for medical devices Regulation impact statement: Proposed regulatory scheme for personalised medical devices, including 3D-printed devices Regulatory changes for software based medical devices Regulatory requirements for in-house IVDs Requirements for the assessment of medical devices containing animal material Researcher considerations for medical devices Software as in vitro diagnostic medical devices (IVDs) The TGA's approach to delays in medical device conformity assessment recertification The use of GMDN codes for IVD medical devices in Australia Updating an existing Class 1-3 in-house IVD notification Use of market authorisation evidence from comparable overseas regulators / assessment bodies for medical devices (including IVDs) Varying entries in the ARTG - medical devices and IVDs What a manufacturer needs to know about conformity assessment and declarations of conformity for IVDs Manufacturing Australian code of good manufacturing practice for human blood and blood components, human tissues and human cellular therapy products Australian code of good wholesaling practice for medicines in schedules 2, 3, 4 & 8 Australian manufacturing licences and overseas GMP certification Compounded medicines and good manufacturing practice (GMP) Faecal microbiota transplant (FMT) products: Interpretative and technical guidance on GMP requirements GMP Clearance code tables guidance GMP information for manufacturers of compounded medicines and DAAs Guideline for the preparation of Technical Master Files for blood, blood components and haematopoietic progenitor cells Guidelines for sterility testing of therapeutic goods Manufacture of sterile radiopharmaceuticals labelled with fluorine-18 Manufacturing principles for medicinal products Manufacturing Quality Branch annual reports Medicinal cannabis manufacture Medicinal gases guidance Ongoing stability testing for listed and complementary medicines PE009, the PIC/S guide to GMP for medicinal products Process validation for listed and complementary medicines Product Quality Reviews (PQRs) for listed and complementary medicines Release for supply of medicines Releasing medicines manufactured at multiple sites S38 guidelines for Australian manufacturing licences covering multiple manufacturing sites Sampling and testing for listed and complementary medicines Site master file preparation: PIC/S explanatory notes for pharmaceutical manufacturers Supplier assessment, approval and qualification for listed and complementary medicines What a manufacturer needs to know about conformity assessment and declarations of conformity for IVDs Electronic submissions Common Technical Document (CTD) eCTD AU module 1 and regional information General dossier requirements NeeS AU module 1 and regional information Submitting data in the eCTD format Submitting data in the NeeS format Biologicals ARGB Appendix 10: Guidance on TGO 105: Standards for faecal microbiota transplant (FMT) products Australian regulatory guidelines for biologicals (ARGB) Biologicals application form - a step-by-step guide Biovigilance responsibilities of sponsors of biologicals Faecal Microbiota Transplant (FMT) product regulation Faecal microbiota transplant (FMT) products: Interpretative and technical guidance on GMP requirements General dossier requirements Pre-submission meetings with TGA Australian Register of Therapeutic Goods (ARTG) Changing the sponsor of therapeutic goods Blood and blood components Australian code of good manufacturing practice for human blood and blood components, human tissues and human cellular therapy products Biovigilance responsibilities of sponsors of biologicals Guideline for the preparation of Technical Master Files for blood, blood components and haematopoietic progenitor cells Disinfectants/Sterilants Disinfectant Claim Guide - specific claims and non-specific claims DR4 Guidance on the regulation of exempt disinfectants in Australia Guidance on the regulation of listed disinfectants in Australia Regulation of borderline disinfectant and related products with antiviral claims including COVID-19 Complementary medicines Analytical procedure validation for complementary medicines Assessed listed medicines evidence guidelines Australian Regulatory Guidelines for Listed Medicines and Registered Complementary Medicines Colourings used in medicines for topical and oral use Comparable overseas bodies (COBs) for complementary medicines Completing a designation or determination extension application form in TGA Business Services Compositional guidelines CTD Module 1: Administrative information for assessed listed medicines Evidence guidelines General dossier requirements Guidance for completing the application form for an assessed listed medicine Guidance on equivalence of herbal extracts in complementary medicines Guidance on the use of modified unprocessed herbal materials in complementary medicines Identification of herbal materials and extracts Introduction to the Permissible Ingredients Determination Listed and assessed listed medicines: Application and submission user guide Mandatory requirements for an assessed listed medicine application to pass preliminary assessment Mandatory requirements for an effective registered complementary medicine application Notifications process: requests to vary registered medicines where quality, safety and efficacy are not affected Ongoing stability testing for listed and complementary medicines Permitted indications for listed medicines guidance Pre-submission meetings with TGA Process validation for listed and complementary medicines Product Quality Reviews (PQRs) for listed and complementary medicines Required Advisory Statements for Medicine Labels (RASML) Sampling and testing for listed and complementary medicines Stability testing of Listed complementary medicines Supplier assessment, approval and qualification for listed and complementary medicines TGA approved terminology for therapeutic goods Clinical trials Clinical trial notification (CTN) form - user guide ICH Guideline for Good Clinical Practice Advertising Advertising guidance for businesses involved with medicinal cannabis products Advertising guidance for businesses involved with stem cells and other human cell or tissue (HCT) products Advertising guidance for providers of disease education activities Advertising to the public Australian Regulatory Guidelines for Advertising Therapeutic Goods (ARGATG) Review of the Therapeutic Goods Advertising Framework Therapeutic goods advertising code Therapeutic goods advertising compliance, 2018-19 annual report Therapeutic goods advertising compliance: 2019-20 Annual Report Medicinal cannabis Guidance for the use of medicinal cannabis for the prevention or management of nausea and vomiting in Australia Guidance for the use of medicinal cannabis in Australia: Overview Guidance for the use of medicinal cannabis in Australia: Patient information Guidance for the use of medicinal cannabis in the treatment of chronic non-cancer pain in Australia Guidance for the use of medicinal cannabis in the treatment of epilepsy in paediatric and young adult patients in Australia Guidance for the use of medicinal cannabis in the treatment of multiple sclerosis in Australia Guidance for the use of medicinal cannabis in the treatment of palliative care patients in Australia Medicinal cannabis manufacture Unapproved therapeutic goods Authorised Prescriber Scheme Therapeutic Goods Administration (TGA) A history of therapeutic goods regulation in Australia An introduction for external clinical evaluators Delivering reforms - Implementation plan for TGA Reforms: A blueprint for TGA's future Half yearly performance snapshot: July to December 2018 Half yearly performance snapshot: July to December 2019 Health Products Regulation Group: Regulatory Science Strategy, 2020-2025 Market research: stage one - qualitative research report Market research: stage two - quantitative research report Performance reports Program implementation guide for TGA staff Regulation impact statement - Review of the low value turnover annual charge exemption scheme Regulatory change: How the TGA legislation and guidelines are amended TGA approach to disclosure of commercially confidential information (CCI) TGA business plan 2020-21 TGA international engagement strategy 2016-2020 TGA international engagement strategy 2016-2020: Highlights and achievements report TGA international engagement strategy 2021-2025 TGA international engagement strategy: operations plan 2018-19 TGA reforms: A blueprint for TGA's future TGA reforms: A blueprint for TGA's future: Progress reports TGA stakeholder surveys Sunscreens Sunscreen manufacturing Shortages Publication of notified medicine shortages: Updated protocol Other therapeutic goods DR4 Guidance on the regulation of menstrual cups in Australia Guidance on the regulation of tampons in Australia OTC medicines ARGOM Appendix 2: Guidelines on quality aspects of OTC applications ARGOM Appendix 3: Guidelines on presentation aspects of OTC applications ARGOM Appendix 4: Guidelines on OTC applications for new substances ARGOM Appendix 5: Guidelines on OTC applications for specific substances Australian regulatory guidelines for OTC medicines (ARGOM) Changing an OTC medicine: using the Changes Tables Colourings used in medicines for topical and oral use Common Technical Document Module 1: OTC medicines Determining the correct application level required for OTC medicines submissions General dossier requirements Mandatory requirements for an effective over-the-counter medicines application Medicine shortages: Report on the first 12 months of the mandatory reporting scheme Notifications process: requests to vary registered medicines where quality, safety and efficacy are not affected OTC application categorisation framework OTC application placement flowchart OTC application placement question and answer tool OTC application route for umbrella branded medicines OTC dossier documents matrix OTC medicines - Safety and efficacy data OTC N2 applications and OTC medicine monographs OTC new medicines registration process Pre-submission meetings with TGA Process to change a registered OTC medicine Publishing OTC medicine PIs and CMIs on the TGA website Required Advisory Statements for Medicine Labels (RASML) Section 19A: Guidance for industry TGA approved terminology for therapeutic goods Medicines safety Addressing prescription opioid use and misuse in Australia Antidepressant utilisation and risk of suicide in young people Consumer Medicine Information (CMI) - How to use the improved CMI template COVID-19 vaccine safety monitoring plan Creating the CMI summary page - Guidance for sponsors Minocycline and agranulocytosis Medicines Guidance for TGO 101 Microbiological quality of medicinal cannabis products Release for supply of medicines Releasing medicines manufactured at multiple sites Prescription medicines Additional trade names guidance - prescription medicines AU eCTD specification: Module 1 and regional information AU NeeS specification: Module 1 and regional information Australian Regulatory Guidelines for Prescription Medicines (ARGPM) Biosimilar medicines regulation Boxed Warning guidance Colourings used in medicines for topical and oral use Common Technical Document (CTD) Comparable overseas regulators (CORs) for prescription medicines Completing a determination or designation application form in TGA Business Services eCTD AU module 1 and regional information Electronic submission of individual case safety reports General dossier requirements Information for applicants completing a pre-submission planning form Literature based submissions Mandatory requirements for an effective application Medicine shortages: Report on the first 12 months of the mandatory reporting scheme NeeS AU module 1 and regional information Notifications process: requests to vary registered medicines where quality, safety and efficacy are not affected Orphan drug designation Orphan drug designation eligibility criteria Pre-submission meetings with TGA Prescription medicines and biologicals annual summaries Priority determination Priority determination eligibility criteria Priority registration process Provisional determination Provisional determination eligibility criteria Provisional registration extension and transition to full registration Provisional registration process Reporting medicine shortages and discontinuations in Australia - Guidance for sponsors Risk management plans for medicines and biologicals Scientific guidelines Seasonal influenza vaccines - quality module Section 19A: Guidance for industry Submitting applications for extension of indications to align with a reference product TGA approved terminology for therapeutic goods Variations to prescription medicines - excluding variations requiring evaluation of clinical or bioequivalence data, Appendix 1: Variation types - chemical entities Variations to prescription medicines - excluding variations requiring evaluation of clinical or bioequivalence data, Appendix 2: Variation types - biological medicines Variations to prescription medicines - excluding variations requiring evaluation of clinical or bioequivalence data: Process guidance Regulatory compliance Enforceable undertaking guidelines Therapeutic goods advertising compliance: 2019-20 Annual Report Scheduling Economic modelling and financial quantification of the regulatory impact of proposed changes to codeine scheduling Introduction to the Poisons Standard National guideline for retail storage of Schedule 6 and Schedule 7 poisons Regulation impact statement: Codeine re-scheduling Scheduling handbook: Guidance for amending the Poisons Standard The Poisons Standard (the SUSMP) Safety of medicines & medical devices Adverse drug reaction reporting using Best Practice: Installing the ADR reporting template Adverse drug reaction reporting using Best Practice: Using the ADR reporting template Adverse drug reaction reporting using Medical Director: Installing the ADR reporting template Adverse drug reaction reporting using Medical Director: Using the ADR reporting template Adverse events: Australian statistics on medical devices Adverse events: Australian statistics on medicines Australian Adverse Drug Reactions Bulletin Brochure: Reporting adverse events to medicines and vaccines Electronic submission of individual case safety reports Help us promote adverse event reporting: promotional resources kit Joint TGA-Medicines Australia guidelines for the design and conduct of company-sponsored post-marketing surveillance studies Manufacturing Quality Branch annual reports Medical device incident reporting & investigation scheme (IRIS) articles Medical device incident reporting (MDIR) guide Medical Devices Safety Update Medicines Safety Update Note for guidance on clinical safety data management: definitions and standards for expedited reporting Pharmacovigilance inspection program: Guidance for medicine sponsors Pharmacovigilance responsibilities of medicine sponsors Reporting medical device adverse incidents Risk management plans for medicines and biologicals Therapeutic product vigilance Trans-Tasman early warning system: Processes in Australia and New Zealand Uniform recall procedure for therapeutic goods (URPTG) The Therapeutic Goods Administration is part of the Health Products Regulation Group
The Therapeutic Goods Administration (TGA) publishes a range of publications, guidelines and forms as part of its regulatory activities. These are aimed at consumers, health professionals or people working in the medical device or medicines industries.
The links below are categorised by topic. This list is also available in an A-Z list.
The Therapeutic Goods Administration is part of the Health Products Regulation Group