Latest Regulatory Affairs Newsletter
A collection of regulatory news from this month.
23rd Australian Total Diet Survey Published (5 December 2011)
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.
Revised Guidelines for OTC Medicines (29 November 2011)
The TGA has invited comment on proposed changes to the regulatory guidelines for OTC medicines. Closing date for comments is 11th February 2012, and proposed changes can be viewed on TGA website. (Source: www.tga.gov.au)
Compositional Guidelines for Complementary Medicine Ingredients (22 November 2011)
Compositional guidelines for “added alpha-casozepine enriched hydrolysed milk protein”, “DHA-rich oil derived from microalgae Schizochytrium sp.”, “Steviol glycosides” and “Zeaxanthin” have been added to the TGA website. (Source: TGA)
Australia to be the First Country to Adopt New Internationally Harmonised Sunscreen Standards (23 November 2011)
Changes include the new definition of “Broad Spectrum” UVA, based on a test which is more stringent than current; and for SPF, a modified test method. Read about these changes in Dermatest’s newsletter. (Source: Dermatest)
TGA Presentations on GMP Posted on Website (22 November 2011)
Topics include GMP audits, clinical trials, release of therapeutic goods for supply in Australia, and quality risk management. (Source: http://www.tga.gov.au/newsroom/events-presentations-manuf.htm)