Skip to Content
Skip to Main Navigation
Skip to Local Navigation
Skip to Search

Publications

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.

Advertising publications

• Price information code of practice
• Schedule 3 advertising guidelines
• Therapeutic goods advertising code

Blood, tissues & biologicals publications

• Australian code of GMP for human blood and tissues
• Australian regulatory guidelines for biologicals (ARGB)
• Guideline for the preparation of Technical Master Files for blood, blood components and haematopoietic progenitor cells
• TGA biologicals framework newsletter

Complementary medicines publications

• Analytical procedure validation for complementary medicines
• Australian regulatory guidelines for complementary medicines (ARGCM)
• Colourings permitted in medicines for oral use
• Electronic listing facility (ELF) user guide
• Guidance on equivalence of herbal extracts in complementary medicines
• Guidance on product changes in ELF3
• Guidance on the use of modified unprocessed herbal materials in complementary medicines
• Guidelines for levels and kinds of evidence to support indications and claims
• Identification of herbal materials and extracts
• Required advisory statements for medicine labels (RASML)
• Stability testing of Listed complementary medicines
• Substances that may be used in Listed medicines in Australia
• TGA approved terminology for medicines

Import/export publications

• Exporting medicines from Australia - operational guidelines
• Personal import scheme

Labelling & packaging publications

• A guide to labelling drugs and poisons
• Best practice guideline on prescription medicine labelling
• NDPSC guide to the packaging, labelling and regulation of paints, tinters and related products
• Required advisory statements for medicine labels (RASML)
• Tamper-evident packaging code of practice

Manufacturing publications

• Australian code of GMP for human blood and tissues
• Australian code of good wholesaling practice for medicines in schedules 2, 3, 4 & 8
• Guidance on licensing/certification inspections
• Guide to interpretation of the Code of GMP for the manufacture of 18-Fludeoxyglucose injections
• Guideline for the preparation of Technical Master Files for blood, blood components and haematopoietic progenitor cells
• Guidelines for sterility testing of therapeutic goods
• Manufacturing principles for medicinal products
• Medicinal gases and good manufacturing practice (GMP)
• Site master file preparation: PIC/S explanatory notes for pharmaceutical manufacturers
• What a manufacturer needs to know about conformity assessment and declarations of conformity for IVDs

Medical devices & IVDs publications

• Application audit (technical file review) of IVD medical device applications
• Australian regulatory guidelines for medical devices (ARGMD)
• Business rules for reduced assessment fees for IVDs
• Classification of IVD medical devices
• Conformity assessment overview (IVDs)
• Conformity assessment procedures for immunohaematology reagents
• Device-medicine boundary products
• Fees and charges for IVD medical devices
• Including IVD medical devices in the ARTG
• Medical device incident reporting & investigation scheme (IRIS) articles
• Reduction of assessment fees for medical devices
• Regulatory requirements for in-house IVDs in Australia
• Requirements for the assessment of medical devices containing animal material
• The use of GMDN codes for IVD medical devices in Australia
• What a manufacturer needs to know about conformity assessment and declarations of conformity for IVDs
• What a sponsor needs to know about conformity assessment and manufacturer's evidence for IVDs

OTC medicines publications

• ARGOM: Guidelines on changes to OTC medicines
• ARGOM: Guidelines on electronic OTC dossiers
• ARGOM: Guidelines on post-market surveillance
• ARGOM: Guidelines on route of evaluation
• ARGOM: Guidelines on the pre-market application and evaluation process for OTC medicines
• Australian regulatory guidelines for OTC medicines (ARGOM)
• Australian regulatory guidelines for sunscreens (ARGS)
• Colourings permitted in medicines for oral use
• Determining the correct application level and supporting information required for OTC medicines submissions
• Guidelines for levels and kinds of evidence to support indications and claims
• 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
• Required advisory statements for medicine labels (RASML)
• TGA approved terminology for medicines

Prescription medicines publications

• Australian regulatory guidelines for prescription medicines (ARGPM)
• Best practice guideline on prescription medicine labelling
• Colourings permitted in medicines for oral use
• European Union guidelines
• Guidance for industry on electronic prescription medicine submission dossiers
• Guideline on prescription medicine discontinuations
• Literature-based submissions - points to consider
• Proposal to amend the Required Advisory Statements for Medicine Labels (RASML)
• Required advisory statements for medicine labels (RASML)
• TGA approved terminology for medicines
• TGA prescription medicines SSP newsletter

Regulatory compliance

• Enforceable undertaking guidelines

Safety of medicines & medical devices publications

• Australian Adverse Drug Reactions Bulletin
• Australian clinical trial handbook
• Australian pharmacovigilance requirements and recommendations for medicine sponsors
• Human Research Ethics Committees and the therapeutic goods legislation
• Joint TGA-Medicines Australia guidelines for the design and conduct of company-sponsored post-marketing surveillance (PMS) studies
• Medical device incident reporting & investigation scheme (IRIS) articles
• Medicines Safety Update
• Note for guidance on clinical safety data management: definitions and standards for expedited reporting
• Note for guidance on good clinical practice
• Reporting adverse drug reactions
• Reporting medical device adverse incidents
• Therapeutic product vigilance
• Uniform recall procedure for therapeutic goods (URPTG)

Scheduling publications

• NCCTG scheduling policy framework
• The Poisons Standard (the SUSMP)

TGA publications

• A history of therapeutic goods regulation in Australia
• Delivering reforms - Implementation plan for TGA Reforms: A blueprint for TGA's future
• TGA advisory committee guidelines
• TGA business plan 2012-2013
• TGA external communication and education framework
• TGA reforms: A blueprint for TGA's future
• TGA reforms: A blueprint for TGA's future: Progress report as at 31 December 2012