14 February 2012
A recent decision by the Federal Court demonstrates that companies can face sizable penalties if they import or supply therapeutic goods in contravention of the Act - even in the absence of a demonstrated health risk to consumers.
Regulatory News - TGA
Regulatory News 
TGA
TGA
29 January 2012
The TGA has published on its website (News Room) a Question and Answer document detailing commonly asked queries about the current submission process.
17 January 2012
Applications are open for appointment to the TGA's statutory advisory committees. Applicants must have expertise in relevant clinical or scientific fields or appropriate consumer issues.
22 December 2011
The TGA has initiated a review of the labelling and packaging regulatory framework for prescription medicines, over the counter medicines and complementary medicines.
An external reference group has been established review consumer health risks related to medicines labels and packaging issues, including potential regulatory options for addressing these risks. In the initial meeting by the external group the following issues were reviewed: dispensing label space, look alike sound alike names and look alike packaging, umbrella branding, active ingredient prominence, small container labelling, label design, blister pack labelling, child resistant packaging and tamper evident packaging.
The TGA is currently exploring some of the suggestions from the group discussion and working with members of the reference group to develop a public consultation paper. The consultation paper is anticipated to be released in early 2012.
22 December 2011
The TGA website contains a excellent summary of the regulations relating to medical devices. In particular the approach taken by the TGA to risk assessment is summarised.
28 November 2011
The TGA website contains a excellent summary of the regulations relating to medical devices. In particular the approach taken by the TGA to risk assessment is summarised.
14 November 2011
The TGA has initiated a review of the labelling and packaging regulatory framework for prescription medicines, over the counter medicines and complementary medicines.
09 September 2011
SUSMP No 2 ( Standard for Uniform Scheduling of Medicine and Poisons, formerly SUSDP) is now available.
The Poisons Standard is the legal title of the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) which has its goal to promote uniform scheduling of substances and uniform labelling and packaging requirements throughout Australia.
08 September 2011
The document which describes the broad risk management approach adopted by the TGA has recently been updated. It has been updated to include the Biologicals Regulatory Framework.
12 July 2011
The TGA have released (17 January 2011) modifications to the streamlined submission process and recommend that sponsors check the application for each document carefully to ensure compliance with the appropriate version.
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