Latest Regulatory Affairs Newsletter

A collection of regulatory news from this month.

11 January 2012 - The TGA has released a compositional guideline for the listed medicine ingredient “natural fish oil” and this can be viewed on the news section of www.tga.gov.au. The TGA also recognises two BP monographs for refined fish oil, namely “Fish Oil, Rich in Omega-3-Acids” and “Farmed Salmon Oil”, along with the monograph for reconfigured fish oil – “Omega-3-Marine Triglycerides”.
11 January 2012 - The bill will replace the Dietary Supplements Regulation and aims to provide a legislative framework for “low-risk natural health products”. The bill is can be viewed on the New Zealand legislation website, and comments are due by 24th February.

FSANZ has approved the enzyme Endoprotease (EC 3.4.21.26) as a processing aid and comment is sought on proposals to allow the enzyme amylomaltase (from genetically modified microorganisms) as a processing aid and dibromo-dimethylhydantoin as a processing aid for poultry and meat.

The response has been released on the TGA website as “TGA reforms: a blueprint for TGA's future”. It addresses concerns about transparency, advertising of therapeutic goods and penalties for non compliance, regulation of complementary medicines and medical devices, and includes a review of health technology.

More than 1500 samples of 92 foods commonly used in Australia were analysed for the presence of agricultural and veterinary contaminants, some mycotoxins and nutrients. Conclusion is that the safety of Australian food supply has been confirmed. Report is published in full on FSANZ website.

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