What's new on this website

July 2008

• Australian Regulatory Guidelines for Medical Devices: Classification of medical devices (draft for comment)
  25 July 2008
• Australian Drug Evaluation Committee 258th meeting recommendations (6 June 2008)
  25 July 2008
• TGA News Issue 56, July 2008
  25 July 2008
• Drugs designated as orphan drugs (added eltrombopag olamine & everolimus)
  25 July 2008
• National Coordinating Committee on Therapeutic Goods (NCCTG) terms of reference (updated)
  24 July 2008
• Australian Drug Evaluation Committee 257th meeting recommendations (4 April 2008)
  24 July 2008
• Guidelines for the preparation of Technical Master Files for blood, blood components and haematopoietic progenitor cells (3rd edition 2008)
  22 July 2008
• Drugs designated as orphan drugs (added miglustat)
  17 July 2008
• Stakeholder consultation on updated Medical Device Standards Orders (MDSOs) and Conformity Assessment Standards Orders (CASOs)
  10 July 2008
• Drugs designated as orphan drugs (added Increlex)
  10 July 2008
• Open day at the TGA
  9 July 2008
• Nanotechnology and therapeutic products
  9 July 2008
• Therapeutic Goods (Listing) Notice 2008 (No.3) (Arabinogalactan - Larix)
  9 July 2008
• Guidance on product changes in ELF3 (updated)
  9 July 2008
• Therapeutic Goods Committee 32nd meeting report
  8 July 2008
• Consultation workshops on regulatory reforms for therapeutic goods
  8 July 2008
• Complementary Medicines Evaluation Committee 66th meeting extracted ratified minutes
  8 July 2008
• Clinical evidence requirements for medical devices
  7 July 2008
• TGA contact details for enquiries about medical devices (updated)
  7 July 2008
• Human papillomavirus vaccine (Gardasil) (updated)
  4 July 2008
• Further advice on recall of blood-thinning medicine - Clexane (enoxaparin)
  3 July 2008
• Australian Regulatory Guidelines for Medical Devices: Draft table of contents
  3 July 2008
• Therapeutic Goods Administration business plan 2008-2009
  1 July 2008

June 2008

• Summary of fees and charges at 1 July 2008
  30 June 2008
• Australian Regulatory Guidelines for Medical Devices: Fees and charges (draft for comment)
  27 June 2008
• Recall coordinators' contact details (June 2008)
  27 June 2008
• Regulation of blood & tissues contact details (updated)
  27 June 2008
• Notice to sponsors - 2008-09 annual charges
  27 June 2008
• Form: Application for declaration that turnover is of low volume and low value for 2008/2009
  27 June 2008
• Drugs designated as orphan drugs (added azacytidine)
  25 June 2008
• Complementary Medicines Evaluation Committee 67th meeting public recommendation summary
  25 June 2008
• Medical Device Evaluation Committee meeting 2008/2 (13 June 2008)
  23 June 2008
  • Meeting report
  • Summary of key resolutions
• The TGA announces the release of TGA electronic Business Services system (eBS) to replace SIME
  20 June 2008
• Required Advisory Statements for Medicine Labels - proposed update 4 (consultation)
  19 June 2008
• Updated advice on recall of blood-thinning medicine - Clexane (enoxaparin)
  17 June 2008
• Therapeutic Goods (Excluded Goods) Order No. 1 of 2008
  17 June 2008
• Medical device standards orders
  16 June 2008
  • Letter about new Medical Device Standards Orders
  • Medical Device Standards Order (Standards for Clinical Evidence) 2008
  • Medical Device Standards Order (Standards for Risk Management) 2008
• Australian Drug Evaluation Committee
  11 June 2008
  • ADEC meeting dates for 2009
  • ADEC Pharmaceutical Subcommittee meeting dates for 2009
• Drugs designated as orphan drugs (added anagrelide hydrochloride)
  11 June 2008
• Therapeutic Goods Order No. 69B Amendment to Therapeutic Goods Order No. 69 General requirements for labels for medicines
  10 June 2008
• Therapeutic Goods Committee 32nd meeting (29 April 2008) summary of key resolutions
  2 June 2008
• Australian Adverse Drug Reactions Bulletin, Volume 27, Number 3, June 2008
  2 June 2008

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