TGA proactive in addressing potential BSE risks

The TGA is taking a proactive approach to ensure that any potential risk of transmission of bovine spongiform encephalopathy (BSE, otherwise known as 'mad cow disease') through the use of medicines and medical devices in Australia is minimised.

In essence, the TGA's actions reflect those being taken in other leading international regulatory agencies, and involve:

• the TGA continuing to require that all new products submitted to the TGA for inclusion on the Australian Register of Therapeutic Goods (ARTG) which contain or use in their manufacture animal or human ingredients should be sourced from BSE-free countries or, where this is not possible, evidence as to the safety from BSE of the material used; and
• the TGA continuing its review of existing products to identify any potential risks of exposure to BSE with a view to removing the use of animal or human products sourced from non-BSE-free countries, except where such use can be fully justified.

Expert evaluations by the TGA of the potential risk of exposure to BSE in products are being coordinated by the TGA Laboratories with the involvement of all branches involved in the regulation of prescription and non-prescription medicines and medical devices. They are based on guidance issued by the European Agency for the Evaluation of Medicinal Products (EMEA) and awareness of the current approach being taken by agencies such as the US FDA.

All new applications for registration of pharmaceutical products that either contain, or are exposed during manufacture to, material of animal or human origin are evaluated for viral and BSE safety by the TGA. Each product is considered individually according to the EMEA guidelines and any other relevant emerging scientific knowledge. This evaluation carefully assesses information about the nature and source of any animal/human ingredients, together with the effectiveness of the manufacturing process in reducing viral/prion safety risks.

In addition, as further scientific information emerges and the number of countries with BSE changes, the TGA is re-reviewing already registered prescription medicines, non-prescription medicines and devices, focussing initially on ingredients and products which might be perceived to be of potentially higher risk. Detailed current information has been requested from manufacturers of these products about the nature, source, and use of any ingredients of animal/human origin in the manufacture of the products. This is being done to update previously held information about these products, and to enable it to be evaluated in the context of new information about the prevalence and impact of BSE. Reviews completed on products such as vaccines indicate that, although a number of them contain ingredients of bovine origin, any risk of potential transmission of BSE is extremely remote and far outweighed by the benefits of immunisation.

In conducting its work in this area, the TGA is liaising closely with, and seeking guidance from, the NHMRC Special Expert Committee on Transmissible Spongiform Encephalopathies. The Committee has endorsed the approach being taken by the TGA.

More information: TGA approach to minimising the risk of exposure to Transmissible Spongiform Encephalopathies (TSEs) through medicines and medical devices <http://www.tga.gov.au/docs/html/tsepolicy.htm>