Latest Regulatory Affairs Newsletter

A collection of regulatory news from this month.

"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:

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".

The TGA has commenced a review of the 2003 Australian regulatory guidelines for OTC medicines and is inviting input from stakeholders (Source:

The new order describes those products that are declared not to be therapeutic goods.

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.


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