Latest Regulatory Affairs Newsletter
A collection of regulatory news from this month.
TGA warns consumers not to buy certain products marketed on the internet as being purely “herbal” when in fact they are contaminated (16 June 2011)
"Pink Lady for Women" has been found to contain tadalafil (the active ingredient in Eli Lilly's product Cialis, which is for male erectile dysfunction) and "St Nirvana herbal slimming capsules" contains the prescription medicine sibutramine (no longer available in Australia due to safety concerns), and also dangerous levels of phenolphthalein (Source: www.tga.gov.au)
Nutrient Reference Values being revised (6 June 2011)
In 2006, the Nutrient Reference Values replaced the 1991 Recommended Dietary Intakes for Use in Australia (RDIs). The FSANZ website states that NRVs "indicate the daily amount of nutrients required for good health, as well as a safe intake of nutrients".
Review of OTC medicine guidelines (6 June 2011)
The TGA has commenced a review of the 2003 Australian regulatory guidelines for OTC medicines and is inviting input from stakeholders (Source: www.tga.gov.au)
Goods that are excluded from being therapeutic goods (6 June 2011)
The new order describes those products that are declared not to be therapeutic goods.
TGA advice for applications for registered complementary medicines (6 June 2011)
Very few applications are submitted for registration of commentary medicines, as the listing process is an easier path to market. New TGA advice has been posted on their website.