Latest Regulatory Affairs Newsletter
A collection of regulatory news from this month.
The distinction between live probiotic ingredients and deliberately killed microorganisms of the same species/strain (3 May 2011)
The 3rd meeting of the ACCM discussed the difference between these two substances, which both have therapeutic benefits. Issues arise as to the correct nomenclature and labelling of products for the consumer.
TGA compositional guidelines are not legally binding (3 May 2011)
A discussion within the ACCM (Advisory Committee on Complementary Medicines) used krill oil as an example. The compositional guideline was drawn up by the TGA in conjunction with the applicant to reflect the nature of their substance. However other suppliers (not the original applicants on the "new substance application") provide krill oil substances which vary from these guidelines.
Compliance with ministerial and default standards (12 April 2011)
All medicines and therapeutic goods in general, must comply with certain standards before they can appear in the ARTG.
TGA warns – do not take Natural Vigra VIAGRA tablets (3 May 2011)
This warning was issued 29th April after TGA laboratory tests revealed the product, promoted as being "100% herbal", actually contains sildenafil, the active ingredient in the prescription medicine Viagra.