Latest Regulatory Affairs Newsletter

A collection of regulatory news from this month.

The TGA has invited comment on proposed changes to the regulatory guidelines for OTC medicines. Closing date for comments is 11th February 2012, and proposed changes can be viewed on TGA website. (Source:

Changes include the new definition of “Broad Spectrum” UVA, based on a test which is more stringent than current; and for SPF, a modified test method. Read about these changes in Dermatest’s newsletter. (Source: Dermatest)

Topics include GMP audits, clinical trials, release of therapeutic goods for supply in Australia, and quality risk management. (Source:

Compositional guidelines for “added alpha-casozepine enriched hydrolysed milk protein”, “DHA-rich oil derived from microalgae Schizochytrium sp.”, “Steviol glycosides” and “Zeaxanthin” have been added to the TGA website. (Source: TGA)

The product names are Capadex, Di-Gesic, Doloxene and Paradex. These products will be cancelled from the Australian Register of Therapeutic Goods on 1st March 2012. The TGA believes that the risks (serious adverse cardiovascular events) outweigh the benefits. (Source: TGA)


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