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Books
- Advertising to the public
- AHMAC - Scheduling policy framework for medicines and chemicals
- AHMAC - Scheduling policy framework for medicines and chemicals, 2015
- Annual performance statistics report: July 2016 to June 2017
- Annual performance statistics report: July 2017 to June 2018
- Applications for orphan drug designation
- ARGB Appendix 4 - Guidance on TGO 88
- ARGOM Appendix 1: Guidelines on efficacy and safety aspects of OTC applications
- 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
- ARGOM: Guidelines on changes to OTC medicines
- ARGOM: Guidelines on the pre-market application and evaluation process for OTC medicines
- Assessed listed medicines evidence guidelines
- AU eCTD specification: Module 1 and regional information
- AU NeeS specification: Module 1 and regional information
- AusPAR user survey results
- Australian clinical trial handbook
- Australian code of good manufacturing practice for human blood and blood components, human tissues and human cellular therapy products
- Australian manufacturing licences and overseas GMP certification
- Australian Public Assessment Report (AusPAR) guidance document
- Australian Regulatory Guidelines for Advertising Therapeutic Goods (ARGATG)
- Australian regulatory guidelines for complementary medicines (ARGCM)
- Australian regulatory guidelines for OTC medicines (ARGOM) (Nov 2012)
- Australian regulatory guidelines for sunscreens (ARGS)
- Authorised Prescriber Scheme
- Basics of therapeutic goods regulation
- Biologicals application form - a step-by-step guide
- Biovigilance responsibilities of sponsors of biologicals
- Changing an OTC medicine: using the Changes Tables
- Changing the sponsor of therapeutic goods
- Classification of IVD medical devices
- Clinical evidence guidelines: Medical devices
- Clinical trial notification (CTN) form - user guide
- Common Technical Document Module 1: OTC medicines
- Compounded medicines and good manufacturing practice (GMP)
- Conforming with Therapeutic Goods (Standard for Medicinal Cannabis) (TGO 93) Order 2017
- Conformity assessment procedures for immunohaematology reagents
- Cost recovery impact statement - Blood, tissues and human cell and tissue therapies, 1 July 2013 - 30 June 2014
- Cost recovery impact statement - Complementary medicines, 1 July 2013 - 30 June 2014
- Cost recovery impact statement - Good manufacturing practice, 1 July 2012 - 30 June 2013
- Cost recovery impact statement - Good manufacturing practice, 1 July 2013 - 30 June 2014
- Cost recovery impact statement - Medical devices, 1 July 2012 - 30 June 2013
- Cost recovery impact statement - Medical devices, 1 July 2013 - 30 June 2014
- Cost recovery impact statement - Over the counter medicines, 1 July 2013 - 30 June 2014
- Cost recovery impact statement - Prescription medicines, 1 July 2013 - 30 June 2014
- Cost recovery impact statement: Blood, blood components and biologicals (human cell and tissue therapies), 1 July 2014 - 30 June 2015
- Cost recovery impact statement: Complementary medicines, 1 July 2014 - 30 June 2015
- Cost recovery impact statement: Good manufacturing practice, 1 July 2014 - 30 June 2015
- Cost recovery impact statement: Medical devices, 1 July 2014 - 30 June 2015
- Cost recovery impact statement: Over the counter medicines, 1 July 2014 - 30 June 2015
- Cost recovery impact statement: Prescription medicines, 1 July 2014 - 30 June 2015
- Cost recovery implementation statement
- Cost recovery implementation statement 2016-17
- Cost recovery implementation statement, V1.1
- Cost recovery implementation statement, V1.2
- Cost recovery implementation statement, V1.3
- Cost recovery implementation statement, V1.4
- Cost recovery implementation statement, V1.5
- Cost recovery implementation statement, V1.6
- Cost recovery implementation statement: Blood, blood components and biologicals (human cell and tissue therapies), From 1 July 2015
- Cost recovery implementation statement: Complementary medicines, From 1 July 2015
- Cost recovery implementation statement: Good manufacturing practice, From 1 July 2015
- Cost recovery implementation statement: Medical devices, From 1 July 2015
- Cost recovery implementation statement: Over the counter medicines, from 1 January 2016
- Cost recovery implementation statement: Prescription medicines, From 1 July 2015
- CTD Module 1
- Defining joint replacement medical devices and ancillary medical devices
- Delivering reforms - Implementation plan for TGA Reforms: A blueprint for TGA's future
- Dossier requirements for Class 2, 3 and 4 biologicals
- DRAFT: Uniform Recall Procedure for Therapeutic Goods
- Economic modelling and financial quantification of the regulatory impact of proposed changes to codeine scheduling
- eCTD AU module 1 and regional information
- Electronic submission of individual case safety reports
- Enforceable undertaking guidelines
- Evaluation of biosimilars
- Evidence guidelines
- Evidence guidelines
- Fees and charges: summary from 1 July 2019
- Fifty years of independent expert advice on prescription medicines
- Final decisions amending, or not amending, the current Poisons Standard, April 2018
- Final decisions amending, or not amending, the current Poisons Standard, November 2018
- Final scheduling decisions and reasons: NCEs and Appendix H
- General dossier requirements
- GMP clearance for overseas manufacturers
- GMP clearance guidance
- Guidance 11: Drug Master Files and Certificates of Suitability of a Monograph of the European Pharmacopoeia for drug substances
- Guidance 15: Biopharmaceutic studies
- Guidance 17: Microbial quality of prescription and over-the-counter medicines
- Guidance 18: Impurities in drug substances and drug products
- Guidance 2: Fees and charges for prescription medicines
- Guidance 8: Product information
- Guidance for completing the application form for an assessed listed medicine
- Guidance for requesting reconsideration of an initial decision
- Guidance for requesting review of regulation 5G, 5K or 5L decisions
- Guidance for TGO 101
- Guidance materials for permitted indications for listed medicines
- Guidance on licensing/certification inspections
- Guidance on product changes in ELF3
- Guidance on the regulation of tampons in Australia
- Guidelines for sterility testing of therapeutic goods
- Half yearly performance report - January to June 2015
- Half yearly performance snapshot: July to December 2016
- Half yearly performance snapshot: July to December 2017
- Half-yearly performance reports - January to June 2014
- Half-yearly performance reports - July to December 2014
- Information for applicants completing a pre-submission planning form
- Information required for an application for evaluation of a substance for use in listed complementary medicines
- Inhalation and nasal spray registered medicines
- Interim decisions and invitation for further comment on substances referred to the March 2019 ACMS/ACCS meetings
- Labelling and packaging practices: A summary of some of the evidence
- Listed and assessed listed medicines: Application and submission user guide
- Management and communication of medicine shortages and discontinuations in Australia
- Mandatory requirements for an assessed listed medicine application to pass preliminary assessment
- Mandatory requirements for an effective application
- Mandatory requirements for an effective over-the-counter medicines application
- Mandatory requirements for an effective registered complementary medicine application
- Manufacture of medicinal cannabis for supply under 'approved access' provisions
- Manufacture of sterile radiopharmaceuticals labelled with fluorine-18
- Market research: stage one - qualitative research report
- Market research: stage two - quantitative research report
- Medical device incident reporting (MDIR) guide
- Medicinal gases guidance
- Medicine labels: Guidance on TGO 91 and TGO 92
- Medicine Shortages Information - The Protocol
- Medicine shortages/discontinuations - Electronic notification form: User guide
- Minor variations to prescription medicines: Review of business processes
- NeeS AU module 1 and regional information
- Notice of a final decision to amend (or not amend) the current Poisons Standard, August 2019
- Notifications process: requests to vary registered medicines where quality, safety and efficacy are not affected
- OTC medicines - Safety and efficacy data
- OTC new medicines registration process
- PE009-13, the PIC/S guide to GMP for medicinal products
- Performance statistics report: July 2015 to June 2016
- Permitted indications for listed medicines guidance
- Pharmacovigilance inspection program: Guidance for medicine sponsors
- Pharmacovigilance responsibilities of medicine sponsors
- Pre-submission Planning Form (PPF)
- Prescription medicines registration process
- Priority review designations medical devices (including IVDs)
- Process to change a registered OTC medicine
- Program implementation guide for TGA staff
- Publication of interim decisions amending, or not amending, the current Poisons Standard, February 2019
- Publication of interim decisions amending, or not amending, the current Poisons Standard, June 2018
- Publication of interim decisions proposing to amend, or not amend, the current Poisons Standard, September 2018
- Recall procedure
- Reduction of assessment fees for medical devices
- Regulation impact statement - Review of the low value turnover annual charge exemption scheme
- Regulation impact statement for reclassification of hip, knee and shoulder joint implants
- Regulation impact statement: Amendments to the new regulatory framework for in vitro diagnostic medical devices (IVDs)
- Regulation impact statement: Changes to premarket assessment requirements for medical devices
- Regulation impact statement: Codeine re-scheduling
- Regulation impact statement: General requirements for labels for medicines
- Regulation impact statement: International harmonisation of ingredient names
- Regulation impact statement: Premarket assessment requirements for Australian manufactured medical devices
- Regulator Performance Framework: Self-assessment Report, July 2016 to June 2017
- Regulator Performance Framework: Self-assessment Report, July 2017 to June 2018
- Regulatory change: How the TGA legislation and guidelines are amended
- Regulatory impact statement (RIS) - update to the Required Advisory Statements for Medicine Labels (RASML)
- Regulatory requirements for in-house IVDs
- Release for supply of medicines
- Release of the Report of the Psychiatric Drug Safety Expert Advisory Panel
- Releasing medicines manufactured at multiple sites
- Revised final decisions amending, or not amending, the current Poisons Standard to correct for minor administrative errors, September 2018
- Risk management plans for medicines and biologicals
- Roles in recalling therapeutic goods
- Roles in recalling therapeutic goods
- Scheduling delegate's final decision: codeine, December 2016
- Scheduling delegate's final decisions, January 2017
- Scheduling delegate's final decisions, January 2017
- Scheduling delegate's final decisions, January 2018
- Scheduling delegate's final decisions, July 2016
- Scheduling delegate's final decisions, June 2016
- Scheduling delegate's final decisions, June 2017
- Scheduling delegate's final decisions, March 2016
- Scheduling delegate's final decisions, March 2017
- Scheduling delegate's final decisions, October 2017
- Scheduling delegate's final decisions. ACMS/ACCS, December 2015
- Scheduling delegate's final decisions: ACCS – Part 2, December 2014
- Scheduling delegate's final decisions: ACCS, April 2015
- Scheduling delegate's final decisions: ACCS, August 2014
- Scheduling delegate's final decisions: ACCS, December 2014
- Scheduling delegate's final decisions: ACCS, July 2015
- Scheduling delegate's final decisions: ACCS, March 2015
- Scheduling delegate's final decisions: ACCS, November 2015
- Scheduling delegate's final decisions: ACCS, October 2014
- Scheduling delegate's final decisions: ACCS/ACMS, April 2014
- Scheduling delegate's final decisions: ACCS/ACMS, February 2013
- Scheduling delegate's final decisions: ACCS/ACMS, June 2013
- Scheduling delegate's final decisions: ACCS/ACMS, November 2013
- Scheduling delegate's final decisions: ACMS and NCEs, July 2015
- Scheduling delegate's final decisions: ACMS, July 2014
- Scheduling delegate's final decisions: ACMS, March 2015
- Scheduling delegate's final decisions: ACMS, May 2015
- Scheduling delegate's final decisions: ACMS, November 2015
- Scheduling delegate's final decisions: ACMS, October 2014
- Scheduling delegate's final decisions: Cannabis and Tetrahydrocannabinols, March 2016
- Scheduling delegate's final decisions: Cannabis, May 2017
- Scheduling delegate's final decisions: December 2013
- Scheduling delegate's final decisions: May 2014
- Scheduling delegate's final decisions: NCEs, April 2016
- Scheduling delegate's interim decisions and invitation for further comment: ACCS, February 2015
- Scheduling delegate's interim decisions and invitation for further comment: ACCS, June 2015
- Scheduling delegate's interim decisions and invitation for further comment: ACCS, November 2014
- Scheduling delegate's interim decisions and invitation for further comment: ACCS/ACMS, February 2015
- Scheduling delegate's interim decisions and invitation for further comment: ACCS/ACMS, February 2016
- Scheduling delegate's interim decisions and invitation for further comment: ACCS/ACMS, July 2013
- Scheduling delegate's interim decisions and invitation for further comment: ACCS/ACMS, July 2016
- Scheduling delegate's interim decisions and invitation for further comment: ACCS/ACMS, June 2014
- Scheduling delegate's interim decisions and invitation for further comment: ACCS/ACMS, March 2016
- Scheduling delegate's interim decisions and invitation for further comment: ACCS/ACMS, March 2017
- Scheduling delegate's interim decisions and invitation for further comment: ACCS/ACMS, March and July 2017
- Scheduling delegate's interim decisions and invitation for further comment: ACCS/ACMS, May 2013
- Scheduling delegate's interim decisions and invitation for further comment: ACCS/ACMS, November 2016
- Scheduling delegate's interim decisions and invitation for further comment: ACCS/ACMS, October 2015
- Scheduling delegate's interim decisions and invitation for further comment: ACMS, February 2015
- Scheduling delegate's interim decisions and invitation for further comment: ACMS, June 2015
- Scheduling delegate's interim decisions and invitation for further comment: ACMS, October 2015
- Scheduling delegate's interim decisions and invitation for further comment:ACCS/ACMS, February 2014
- Scheduling delegates' final decisions: NCEs, May 2018
- Scheduling delegates' interim decisions and invitation for further comment: ACCS/ACMS, November 2017
- Scheduling handbook: Guidance for amending the Poisons Standard
- Seasonal flu vaccine: Overview of vaccine regulation and safety monitoring and investigation into adverse events following 2010 seasonal influenza vaccination in young children
- Seasonal influenza vaccines - quality module
- Section 19A: Guidance for industry
- Special Access Scheme: Guidance for health practitioners and sponsors
- Stability testing for prescription medicines
- Substantial changes affecting a TGA conformity assessment certificate and Transfers of certificates
- Sunscreen manufacturing
- Testing of biological medicines
- TGA advisory committee guidelines
- TGA approach to disclosure of commercially confidential information (CCI)
- TGA business plan 2012-2013
- TGA business plan 2013-2014
- TGA business plan 2014-2015
- TGA business plan 2015-2016
- TGA business plan 2016-17
- TGA business plan 2017-18
- TGA consumer survey 2018
- TGA external communication and education framework
- TGA international engagement strategy 2016-2020
- TGA key performance indicators: January to June 2014
- TGA key performance indicators: January to June 2015
- TGA key performance indicators: July 2015 to June 2016
- TGA key performance indicators: July to December 2013
- TGA key performance indicators: July to December 2014
- TGA medicine labelling and packaging review
- TGA reforms: A blueprint for TGA's future
- TGA reforms: A blueprint for TGA's future (December 2011)
- TGA reforms: A blueprint for TGA's future: Progress report as at 30 June 2013
- TGA reforms: A blueprint for TGA's future: Progress report as at 30 June 2014
- TGA reforms: A blueprint for TGA's future: Progress report as at 31 December 2012
- TGA reforms: A blueprint for TGA's future: Progress report as at 31 December 2013
- TGA reforms: A blueprint for TGA's future: Progress report as at 31 December 2014
- TGA stakeholder survey 2016
- TGA stakeholder survey 2017
- TGA stakeholder survey 2018
- Toxicity of tartrazine
- Transition to new GMP requirements for medicinal products
- Uniform recall procedure for therapeutic goods (URPTG), 2004 edition
- 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
- Varying entries in the ARTG - medical devices and IVDs
- What a manufacturer needs to know about conformity assessment and declarations of conformity for IVDs
- Scheduling delegate's interim decisions and invitation for further comment: ACMS, September 2014
- Scheduling delegate's interim decisions and invitation for further comment: ACCS/ACMS, September 2014