What's new on this website
June 2009
30 June 2009
- Uniform recall procedure for therapeutic goods (URPTG) (updated Recall coordinators' contact details)
- Important notice - TGA fees and charges 2009-10 (new)
- The OTC medicines team (updated)
29 June 2009
- Adoption of European Union guidelines in Australia (1 consultation document)
- European Union guidelines (6 adopted, 1 replaced)
26 June 2009
- European Union guidelines (4 adopted, 1 replaced)
- Electronic listing facility (ELF) user guide (updated)
- Australian regulatory guidelines for OTC medicines (ARGOM) (updated Chapter 10 Sunscreens)
- Australian regulatory guidelines for OTC medicines (ARGOM) - Amendment schedule (updated)
24 June 2009
23 June 2009
- Regulatory reform (updated)
- Questions and answers relating to the additional default standards legislation (new)
- Conformity assessment bodies (CABs) approved to undertake assessments to the Australian requirements (updated)
22 June 2009
- European Union guidelines (3 adopted, 1 replaced)
- Complementary Medicines Evaluation Committee members (updated)
19 June 2009
18 June 2009
- Adoption of European Union guidelines in Australia (4 consultation documents)
- Cost recovery impact statement - annual review of fees and charges 2009-10
16 June 2009
- Drugs designated as orphan drugs (added midazolam)
11 June 2009
9 June 2009
- Complementary Medicines Evaluation Committee 71st meeting extracted ratified minutes (new)
- Therapeutic Goods Committee 34th meeting summary of key resolutions (new)
4 June 2009
- Medical device incident reports 01/01/2009 to 31/03/2009 (new)
- Drugs designated as orphan drugs (added caprine hyperimmune serum, human fibrinogen, octreotide, pentostatin)
3 June 2009
- Presentation: Quality Risk Management - TGA perspective
- Australian Regulatory Guidelines for Medical Devices (Consultation documents)
- Differences between the Australian and European Union medical device regulatory requirements (draft)
- Medical devices containing materials of animal, microbial or recombinant origin (draft)
- Systems and procedure packs (draft)
2 June 2009
1 June 2009
- Online survey: TGA communications & consultation processes (new)
- Australian Adverse Drug Reactions Bulletin, Volume 28, Number 3, June 2009 (new)
- Cooperative arrangement between the TGA and the European Directorate for the Quality of Medicines and HealthCare of the Council of Europe (EDQM)
May 2009
29 May 2009
- Complementary Medicines Evaluation Committee: Appointment of new member (expressions of interest)
- National Drugs and Poisons Schedule Committee: Appointment of new member (expressions of interest)
- First bill passed by Parliament to enhance the Therapeutic Goods Act 1989 (updated)
28 May 2009
27 May 2009
- Complementary Medicines Evaluation Committee 72nd meeting, public recommendation summary (new)
- Office of Manufacturing Quality presentation: The TGA and Process Analytical Technology (new)
21 May 2009
- Drugs designated as orphan drugs (added somatropin (rbe) and zoledronic acid)
20 May 2009
15 May 2009
14 May 2009
13 May 2009
- Technical working groups (new)
11 May 2009
- Definition of British Pharmacopoeia (BP 2009) (new)
- Drugs designated as orphan drugs (added Thromboreductin)
8 May 2009
- APEC-funded Asian medical devices regulatory harmonization delegation visit to Australia (20-25 September 2009)
- Advice to consumers regarding Hydroxycut products (new)
6 May 2009
5 May 2009
- Media release: TGA announcement regarding extension of shelf life of oseltamivir (Tamiflu®) (new)
- Human papillomavirus vaccine (GARDASIL) (updated)
4 May 2009
- Drugs designated as orphan drugs (added mannitol)
1 May 2009
- European Union guidelines (7 adopted, 5 replaced)