Latest Regulatory Affairs Newsletter
A collection of regulatory news from this month.
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: 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.
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)
Trans-Tasman agency back on the agenda (20 June 2011)
At a meeting today of Australia’s Prime Minister Julia Gillard and New Zealand’s Prime Minister John Key it was announced that the governments have decided to set up a joint medicine and medical device agency. This resurrects discussions held in the early 2000s which did not come to fruition. The proposed new agency will at first exclude complementary medicines and dietary supplements until a mutually acceptable regulatory framework is agreed on.