TGA Internet site archive
The content on this page and other TGA archive pages is provided to assist research and may contain references to activities or policies that have no current application. See the full archive disclaimer.
Archived TGA publications & articles
- A review of the regulation of head lice preparations in Australia (15 July 2004)
- Access to unapproved therapeutic goods - Clinical trials in Australia (1 October 2004)
- Advertising regulatory framework - options for reform (29 May 2012)
- AHMAC - Scheduling policy framework for medicines and chemicals, 2015 (12 February 2015)
- Amendments to the regulations, 2010 (23 June 2010)
- Applications for orphan drug designation (3 March 2016)
- ARGCM Part C, V7.2 February 2018 (archived) (15 February 2018)
- ARGOM Appendix 1: Guidelines on efficacy and safety aspects of OTC applications (29 November 2015)
- ARGOM: Guidelines on changes to OTC medicines (29 November 2015)
- ARGOM: Guidelines on electronic OTC dossiers (29 November 2015)
- ARGOM: Guidelines on post-market surveillance (9 November 2012)
- ARGOM: Guidelines on route of evaluation (29 November 2015)
- ARGOM: Guidelines on the pre-market application and evaluation process for OTC medicines (29 November 2015)
- AusPAR project (24 August 2010)
- Australia New Zealand Therapeutic Products Agency (ANZTPA)
- Australian clinical trial handbook, 2006 (16 March 2006)
- Australian code of GMP for human blood and tissues (2000) (24 August 2000)
- Australian code of GMP for therapeutic goods - sunscreen products (1994) (1 February 1994)
- Australian code of good manufacturing practice for medicinal products (16 August 2002) (16 August 2002)
- Australian code of good wholesaling practice for therapeutic goods for human use (1 November 1991)
- Australian Government Response to the recommendations of the review (Bansemer Report) (20 November 2006)
- Australian pharmacovigilance requirements and recommendations for medicine sponsors (12 November 2013)
- Australian Public Assessment Report (AusPAR) guidance (25 October 2010)
- Australian regulatory guidelines for complementary medicines (ARGCM) (archived) (26 July 2012)
- Australian regulatory guidelines for OTC medicines (ARGOM) (29 November 2015)
- Australian regulatory guidelines for OTC medicines (ARGOM) (archived)
- Australian regulatory guidelines for OTC medicines (ARGOM) (Nov 2012) (9 November 2012)
- Australian regulatory guidelines for prescription medicines (ARGPM) (archived) (21 May 2013)
- Best practice guideline on prescription medicine labelling (17 November 2008)
- Better information on medicine labels - have your say (24 May 2012)
- Business rules for reduced assessment fees for IVDs (8 August 2012)
- Colourings permitted in medicines for oral use (4 May 2011)
- Common technical document (CTD) (28 April 2011)
- Consumer guide to commonly noted advertising breaches (3 August 2011)
- Cosmetic claims guidelines (9 May 1997)
- Cost recovery implementation statements (archived)
- Evaluation of biosimilars (30 July 2013)
- Fees and charges for IVD medical devices (16 August 2010)
- Fifty years of independent expert advice on prescription medicines (12 February 2014)
- GMP clearance for overseas manufacturers (16 May 2011)
- Guidance for industry on electronic prescription medicine submission dossiers (4 January 2011)
- Guidance on licensing/certification inspections (29 April 2013)
- Guidance on product changes in ELF3 (2008) (28 August 2008)
- Guidance on Therapeutic Goods Order No. 80 Child-resistant packaging requirements for medicines (12 September 2008)
- Guide to interpretation of the Australian Code of Good Manufacturing Practice for Medicinal Products (16 August 2002) applicable to the manufacture of complementary medicines (1 December 2003)
- Guideline on prescription medicine discontinuations (17 October 2007)
- Guidelines for levels and kinds of evidence to support indications and claims
- Honey - scientific report (1 December 1998)
- Human Research Ethics Committees and the therapeutic goods legislation (26 June 2001)
- Improved TGA website search engine (29 July 2014)
- Improving international cooperation between regulators (31 October 2011)
- Manufacturing principles for medicinal products (2013) (29 April 2013)
- Medical products and the Internet
- Medicines information kit (1 November 1999)
- Minor variations to registered prescription medicines: Biological medicines (14 May 2013)
- Minor variations to registered prescription medicines: Chemical entities (14 May 2013)
- NCCTG scheduling policy framework (1 July 2010)
- Note for guidance on good clinical practice, July 2000 (7 July 2000)
- Number of valid reports in adverse reactions database reaches 250,000 (4 April 2012)
- OTC application categorisation framework (22 March 2013)
- OTC dossier documents matrix (22 March 2013)
- Reducing the public health risks associated with reusable medical devices (31 May 2004)
- Regulation of internationally controlled drugs moves to the TGA (11 September 2014)
- Regulatory impact statement for a price information code of practice (4 August 2005)
- Report of a review of advertising therapeutic products in Australia and New Zealand (25 June 2003)
- Report on cost recovery arrangements relating to the regulation of the medicines, medical devices and blood products by the Therapeutic Goods Administration (6 July 2005)
- Report to Health Ministers on a cost-benefit analysis of pharmacist only (S3) and pharmacy medicines (S2) and risk-based evaluation of the standards (25 January 2006)
- Required advisory statements for medicine labels (archived)
- Review of Aspirin / Reye's syndrome warning statement (30 April 2004)
- Review of Australian arrangements for clinical trials and access to unapproved therapeutic goods (5 April 2005)
- Review of drugs, poisons and controlled substances legislation (the Galbally Review) (15 September 2008)
- Review of non-prescription analgesics: an update (11 April 2003)
- Review of the need for further regulation of extemporaneous compounding (21 September 2005)
- Review of the Therapeutic Goods Administration's consultative arrangements (30 April 2004)
- Review of the Uniform Recall Procedure for Therapeutic Goods (28 May 2004)
- Tamper-evident packaging guideline (22 December 2000)
- TGA advisory committee guidelines (7 September 2016)
- TGA biologicals framework newsletter
- TGA business plan 2012-2013 (7 November 2012)
- TGA business plan 2013-2014 (19 December 2013)
- TGA business plan 2014-2015 (25 November 2014)
- TGA business plan 2015-2016 (1 March 2016)
- TGA business plan 2016-17 (29 November 2016)
- TGA customer service charter (1 October 2010)
- TGA external communication and education framework (21 December 2012)
- TGA international engagement strategy 2013-2015 (1 August 2013)
- TGA international engagement strategy 2013-2015 (9 October 2014)
- TGA key performance indicators: January to June 2014
- TGA prescription medicines SSP newsletter (21 September 2012)
- TGA reforms: A blueprint for TGA's future (December 2011) (8 December 2011)
- TGA report on information and advertising associated with products tested, created or manufactured using human embryos or human embryonic stem cells (16 September 2003)
- Therapeutic Goods Amendment (2009 Measures No 1) Act 2009
- Therapeutic Goods Amendment (2009 Measures No 2) Act 2009
- Therapeutic Goods Amendment (2009 Measures No 3) Act 2010
- Therapeutic Goods Amendment (2010 Measures No 1) Bill 2010
- Therapeutic Goods Amendment (Medical Devices and Other Measures) Act 2009
- Uniform recall procedure for therapeutic goods (URPTG), 2004 edition (12 April 2017)
- Upgrade to TGA website (23 October 2014)
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- URL:https://www.tga.gov.au/node/4618