TSE

The Australian Therapeutic Goods Administration (TGA) has issued guidelines to reduce the risk of exposure to transmissible spongiform encephalopathies (TSEs) through the use of medical devices and medicines1,2. The guidelines, issued on 15 December 2004, are consistent with actions taken by the US, Canada, Japan and the UK, which either advise against or prohibit the use of ruminant animal-derived ingredients in the manufacture of medical products from countries which have reported cases of bovine spongiform encephalopathy (BSE). If a therapeutic good is injectable, implantable, or introduced through intra-ocular or intra-tracheal routes and if it either contains or is manufactured using materials or reagents of ruminant origin, it must be evaluated by the TGA for safety.

The TGA proposes that this will be achieved by, for example, continuing to review existing medical devices and medicines to identify possible risks of exposure to TSE, with a view...