Latest Regulatory Affairs Newsletter

A collection of regulatory news from this month.

Australian manufacturer Capilano has launched what it states is the world’s first clinically tested prebiotic honey.   Source: By Gary Scattergood, Food Navigator-Asia Prebiotic honey

The following information is aimed at providing sponsors with a better understanding of common compliance issues and how they can be avoided. The Therapeutic Goods Administration believes that sponsors want to do the right thing and hopes that this information will provide clarity around regulatory requirements so that sponsors can more easily comply with the law.   Source: TGA education

The Australian regulatory guidelines for complementary medicines (ARGCM) provide information for manufacturers, sponsors, healthcare professionals and the general public on the regulation of complementary medicines in Australia. If you want to supply a complementary medicine in Australia, you may choose to employ a regulatory affairs consultant.   Source: CM guidelines

The Therapeutic Goods Administration has listed the changes to ingredient availability in the amended Therapeutic Goods (Permissible Ingredients) Determination No. 2 of 2016. The list includes new allowable ingredients, Removal of one previously allowed ingredient, and, Changes to ingredient requirements.   Sources: Permissible ingredient update 1 ; Permissible ingredient update 2

Bee Sexy Slimming capsules - The Therapeutic Goods Administration has tested a product labelled Bee Sexy Slimming capsules and found that the capsules contain the undeclared substance sibutramine. Consumers are advised that sibutramine is a prescription-only substance in Australia. Sibutramine was withdrawn from world markets in 2010 due to increased risk of cardiac events and stroke.   Source: Bee sexy

Vigour 300 tablets - The TGA has tested a product labelled Vigour 300 tablets and found that the tablets contain the undeclared substance sildenafil (active ingredient in Viagra).   Source: Vigour 300


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