Latest Regulatory Affairs Newsletter

A collection of regulatory news from this month.

“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.

The closing date for comments on the TGA’s compositional guideline is 30th July. (Source: www.tga.gov.au)

Significant changes include simpler labelling, with clarification on SPF numbers, and “water resistance” and “broad spectrum” claims.

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)

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.

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