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'No TSE risk' from North American bovine products

25-Aug-2004

The emergence of cases of mad cow disease in North America has not raised any public health concern from animal-derived medicinal materials such as bovine blood derivatives and gelatin.

However, the situation has thrown up some regulatory compliance issues for manufacturers supplying products such as acid bone gelatin and adult bovine serum, according to the European Medicines Agency (EMEA).

The discovery that so-called transmissible spongiform encephalopathies (TSEs) can be contracted by consuming contaminated meat has made the safety of animal-derived products an issue of great concern to regulators.

European regulations requiring registration and testing and inactivation procedures to minimise risk were developed and came into force for approved medical products in 1999, followed by unlicensed products last year.

The first cases of bovine spongiform encephalopathy were identified in Canada in May 2003 and the US in December 2003. The announcement of the cases - and the likely upgrading of the US and Canada by the European Food Safety Authority to GBR (Geographical BSE Risk) III status from GBR II - prompted a risk assessment by the Biotechnology Working Party (BWP) of the EMEA's Committee for Proprietary Medicinal Products (CPMP).

Overall, the probe has concluded that additional or existing measures put in place by the US and Canada are adequate to ensure that there is no public health risk for bovine-derived blood and serum products and gelatin derived from hides, or indeed from milk-derived ingredients - such as lactose - that may find their way into pharmaceutical products.

However, for gelatin coming from bones, the upgrading to GBR III status means that suppliers will have to ensure that their source material conforms to more stringent safety measures.

For example, vertebrae pose a risk of contamination with central nervous system material and so must be removed from bones intended for human use if the animal is over 12 months old. Discussion is ongoing amongst regulators to demand a total ban on the use of vertebrae in gelatin sourcing.

Also, companies which use the acid extraction process for gelatin production from bones will be unable to use North American materials in the wake of an upgrade to GBR III status. At present there is no such restriction on the alkaline extraction process.

So while there is no public health risk, companies sourcing acid bone gelatin from North America may find themselves running into regulatory problems, according to the EMEA.

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