Latest Regulatory Affairs Newsletter
A collection of regulatory news from this month.
Cannabis-like drugs prohibited from 8th July (8 July 2011)
Parliament has announced that 8 synthetic cannabis-like substances will be classified as prohibited substances throughout Australia from 8 July.
TGA policy on claims for listed medicines relating to cholesterol, blood pressure and blood sugar (8 July 2011).
“Biomarkers” such as cholesterol and blood glucose, may be referred to in claims for listed medicines only if they relate to maintaining healthy levels in normal people.
Draft compositional guideline: DHA-rich oil derived from microalgae Schizochytrium species (28 June 2011)
The closing date for comments on the TGA’s compositional guideline is 30thJune. However, the TGA’s compositional guidelines are not legally enforceable. (Source: www.tga.gov.au)
Draft compositional guideline: Steviol glycosides (28 June 2011)
The closing date for comments on the TGA’s compositional guideline is 30th July. (Source: www.tga.gov.au)
FDA Releases final Sunscreen Monograph (22 June 2011)
Significant changes include simpler labelling, with clarification on SPF numbers, and “water resistance” and “broad spectrum” claims.