Expert review of medicines and medical devices regulation (TGA - Therapeutic...
(Source: TGA - Therapeutic Goods Administration) 24 October 2014 On 24 October 2014 the Australian Government announced a review of the regulation of medicines and medical devices. The Review will be...
View ArticleHalf-yearly performance reports - January to June 2014 (TGA - Therapeutic...
(Source: TGA - Therapeutic Goods Administration) 17 October 2014 The TGA prepares statistical performance reports that are presented biannually to the Therapeutic Goods Industry Consultative Committee...
View ArticleACMD meeting statement, Meeting 15, 13 June 2014 (TGA - Therapeutic Goods...
(Source: TGA - Therapeutic Goods Administration) Advisory Committee on Medical Devices 13 June 2014 Role of the Advisory Committee on Medical Devices (ACMD) in the TGA's regulatory decision making...
View ArticleStatutory expert committee forms (TGA - Therapeutic Goods Administration)
(Source: TGA - Therapeutic Goods Administration) These forms are available in pdf and Microsoft Word formats. The pdf form can be filled in and saved to your computer using...
View ArticleTGA presentation given at the AusMed Tech conference, 16 May 2013 (TGA -...
(Source: TGA - Therapeutic Goods Administration) Presentation by: Judy Develin, Head, Market Authorisation Group, TGA Presented at: AusMedTech conference, Melbourne, 16 May 2013 Presentation summary:...
View ArticleAustralian eCTD submissions (TGA - Therapeutic Goods Administration)
(Source: TGA - Therapeutic Goods Administration) 27 June 2014 The TGA is implementing software to validate, review and process electronic applications for the entry of registered medicines on to the...
View ArticleClient details form (TGA - Therapeutic Goods Administration)
(Source: TGA - Therapeutic Goods Administration) This form should be completed by or for each Client involved with the supply of the therapeutic goods in Australia for...
View ArticleACPM meeting statement, Meeting 291, 6-7 June 2013 (TGA - Therapeutic Goods...
(Source: TGA - Therapeutic Goods Administration) Advisory Committee on Prescription Medicines 6 June 2013 Role of the Advisory Committee on Prescription Medicines (ACPM) in the TGA's regulatory...
View ArticleTGA website - new mobile friendly version (TGA - Therapeutic Goods...
(Source: TGA - Therapeutic Goods Administration) Your browser appears to have JavaScript disabled. The TGA mobile website works best with JavaScript enabled. 5 June 2013 From 5 June 2013 onwards if you...
View ArticleConsultation: Australian regulatory guidelines for complementary medicines...
(Source: TGA - Therapeutic Goods Administration) 21 January 2013 Closing date: 18 February 2013 Consultation documents * Consultation: Australian regulatory guidelines for complementary medicines...
View ArticleTGA presentation given at ARCS Regulatory Affairs Interest Area Committee...
(Source: TGA - Therapeutic Goods Administration) Presented by: Jenny Burnett, Director, Evaluation Management, Office of Medicines Authorisation...
View ArticleApplication guidelines (TGA - Therapeutic Goods Administration)
(Source: TGA - Therapeutic Goods Administration) European Union guidelines adopted in Australia 2 May 2014 To search for a guideline by key word on this page, use your browser's 'Find' function...
View ArticleInformation sessions on proposed OTC business process reforms (TGA -...
Communication with industry 28 September 2012 Medsafe and the TGA have worked together to develop proposals regarding reforms to the business processes for the evaluation of over-the-counter (OTC)...
View ArticleConsultation: Famciclovir: proposed advisory statements for medicines (TGA -...
Version 1.0 9 November 2012 Closing date: Friday, 7 December 2012 Invitation to comment The TGA is seeking comments from interested parties on the proposed advisory statements for famciclovir when...
View ArticleTGA presentations given to Industry regarding the current Request for Tender...
(Source: TGA - Therapeutic Goods Administration) Toxicology evaluation Presented by: Senior Toxicologists, Office of Scientific Evaluation Presented at: Brisbane, Adelaide, Sydney, Melbourne and...
View ArticleDraft compositional guideline: Calcified Lithothamnion tophiforme (TGA -...
(Source: TGA - Therapeutic Goods Administration) 15 January 2013 This consultation opened on 15 January 2013 and closed on 26 February 2013. The TGA sought comments from interested parties on the draft...
View ArticleElectronic funds transfer agreement (TGA - Therapeutic Goods Administration)
(Source: TGA - Therapeutic Goods Administration) Electronic funds transfers will be accepted following completion of an Electronic Funds Transfer Agreement Form (to ensure the payment is correctly...
View ArticleConsultation forecast (TGA - Therapeutic Goods Administration)
(Source: TGA - Therapeutic Goods Administration) 1 March 2013 The consultation forecast provides an indication of the major consultations scheduled by the TGA for release during the next 12 months. In...
View ArticleConsultation: Azelastine: proposed advisory statements for medicines (TGA -...
Version 1.0 9 November 2012 Closing date: 7 December 2012 Invitation to comment The TGA is seeking comments from interested parties on the proposed advisory statement for azelastine when included in...
View ArticleConsultation: Esomeprazole: proposed advisory statements for medicines (TGA -...
(Source: TGA - Therapeutic Goods Administration) 12 September 2014 Closing date: 10 October 2014 Invitation to comment The TGA is seeking comments from interested parties on proposed advisory...
View ArticleTGA reforms: A blueprint for TGA's future: Progress report as at 30 June 2014...
(Source: TGA - Therapeutic Goods Administration) 25 September 2014 TGA reforms: A blueprint for TGA's future - Progress report as at 30 June 2014 is the fourth six monthly progress report on reforms...
View ArticleAustralian Therapeutic Goods Advisory Council (TGA - Therapeutic Goods...
(Source: TGA - Therapeutic Goods Administration) 16 January 2013 Introduction On 16 July 2012, the Australian Government announced that it would establish an Australian Therapeutic Goods Advisory...
View ArticleConsultation: Loratadine and desloratadine: proposed advisory statements for...
Version 1.0 9 November 2012 Closing date: 7 December 2012 Invitation to comment The TGA is seeking comments from interested parties on the proposed advisory statement for loratadine and desloratadine...
View ArticleConsultation: Review of cardiovascular safety of non-steroidal...
(Source: TGA - Therapeutic Goods Administration) 7 October 2014 Closing date: 6 November 2014 Invitation to comment The TGA is seeking comments from interested parties following a Review of...
View ArticleConsultation principles for therapeutic goods regulatory reforms (TGA -...
(Source: TGA - Therapeutic Goods Administration) Your browser appears to have JavaScript disabled. The TGA mobile website works best with JavaScript enabled. 21 June 2013 We have...
View ArticleConsultation: Changes to premarket assessment requirements for medical...
(Source: TGA - Therapeutic Goods Administration) Closing date: Friday 15 March 2013 Consultation documents * Changes to premarket assessment requirements for medical devices: Proposal paper (Microsoft...
View ArticleConsultation: Permitted (coded) indications for listed medicines (TGA -...
(Source: TGA - Therapeutic Goods Administration) 14 January 2013 Closing date: Friday 15 March 2013 Consultation documents Consultation: Permitted (coded) indications for listed medicines Consultation:...
View ArticleConsultation: Medicine labelling (TGA - Therapeutic Goods Administration)
(Source: TGA - Therapeutic Goods Administration) 22 August 2014 Closing date: 7 October 2014 Invitation to comment The TGA is seeking comments from interested parties on any, or all, of the proposed...
View ArticleConsultation: Draft OTC medicine monograph for loperamide hydrochloride (TGA...
(Source: TGA - Therapeutic Goods Administration) 12 September 2014 Closing date: 10 October 2014 Invitation to comment The TGA is seeking comments from interested parties on the draft OTC medicine...
View ArticleConsultation: Draft OTC medicine monograph for ranitidine hydrochloride (TGA...
(Source: TGA - Therapeutic Goods Administration) 12 September 2014 Closing date: 10 October 2014 Invitation to comment The TGA is seeking comments from interested parties on the draft OTC medicine...
View ArticleConsultation: Draft OTC medicine monograph for mebendazole (TGA - Therapeutic...
(Source: TGA - Therapeutic Goods Administration) 12 September 2014 Closing date: 10 October 2014 Invitation to comment The TGA is seeking comments from interested parties on the draft OTC medicine...
View ArticleConsultation: Draft OTC medicine monograph for guaifenesin (TGA - Therapeutic...
(Source: TGA - Therapeutic Goods Administration) 12 September 2014 Closing date: 10 October 2014 Invitation to comment The TGA is seeking comments from interested parties on the draft OTC medicine...
View ArticleInaccuracies in clinical trial statistics reporting for the period 2009-2012...
(Source: TGA - Therapeutic Goods Administration) 1 August 2013 The Therapeutic Goods Administration (TGA) has identified errors in its internal reports of clinical trial numbers for the period 1 July...
View ArticleDocuments released under Section 11C of the Freedom of Information Act 1982...
(Source: TGA - Therapeutic Goods Administration) Related information *Large file warning:Attempting to open large files over the Internet within the browser window may cause problems. It is strongly...
View ArticleRequired advisory statements for medicine labels (RASML) (TGA - Therapeutic...
9 November 2012 The RASML document is a compilation of all mandatory medicine label advisory statements, including those from the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP) and...
View ArticleRegulation impact statement: Premarket assessment requirements for Australian...
(Source: TGA - Therapeutic Goods Administration) 15 October 2014 This Regulation Impact Statement (RIS) has been prepared by the Therapeutic Goods Administration (TGA). The purpose is to assist...
View ArticleTGA key performance indicators: January to June 2014 (TGA - Therapeutic Goods...
(Source: TGA - Therapeutic Goods Administration) Version 1.0, August 2014 Version history Version Description of change Author Effective date V1.0 Original publication TGA August 2014 TGA key...
View ArticleReview of cardiovascular safety of non-steroidal anti-inflammatory drugs (TGA...
(Source: TGA - Therapeutic Goods Administration) Version 2.1, October 2014 7 October 2014 A review has been carried out of the relevant medical literature published since 2005 and other relevant data...
View ArticleSafety review of diclofenac (TGA - Therapeutic Goods Administration)
(Source: TGA - Therapeutic Goods Administration) Version 2.1, October 2014 7 October 2014 Following the cardiovascular safety review of all NSAIDs and concerns regarding the...
View ArticleHalf-yearly performance reports - July to December 2013 (TGA - Therapeutic...
(Source: TGA - Therapeutic Goods Administration) 28 May 2014 The TGA prepares statistical performance reports that are presented biannually to the Therapeutic Goods Industry Consultative...
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