Supplementary information on Transmissible Spongiform Encephalopathies (TSEs) regulation

2 April 2014

The TGA updated its approach to minimising the transmission of TSEs (Transmissible Spongiform Encephalopathies) in 2014. The following information summarises the changes. The updated "approach to minimising the transmission of TSEs" will come into effect from the date of publication.

Changes to TGA's approach to TSE minimisation

The TGA formulated its 2004 TSE policy to minimise transmission of TSEs based on scientific knowledge at the time. This policy categorised countries according to the risk categories used by the World Organisation of Animal Health (abbreviated OIE, reflecting the original name, Office International des Epizooties). However, these categories have changed.

One form of TSE that has been a cause for concern is BSE (Bovine Spongiform Encephalopathy), also known as 'mad cow disease'. Bovine materials are commonly used during manufacture of certain therapeutic goods. Thus regulatory agencies around the world formulated TSE policies in order to minimise potential transmission of BSE via therapeutic goods. BSE is now well regulated in Europe.

Worldwide the reported cases of BSE has declined to a near zero level, resulting in changes to the OIE BSE risk country classifications. The OIE currently divides countries into the following three categories:

  • negligible BSE risk
  • controlled BSE risk
  • undetermined BSE risk.

The European Commission has adopted the OIE country classification and guidance has been produced by the European Medicines Agency (EMA) (Note for guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products,EMA/410/01 Rev.3).

The European Pharmacopoeia has adopted this EMA guidance, which includes the OIE country classifications.

Further, extensive scientific research during the last decade has indicated that the tissue distribution of prions, the infective agent of TSE, in naturally infected cattle is more limited than previously thought. This is also reflected in the European Pharmacopoeia.

The European Pharmacopoeia is one of the default standards named in the AustralianTherapeutic Goods Act 1989.

In the 2014 TGA approach to TSE minimisation:

  • the European Pharmacopoeia is acknowledged as the default standard for TSE risk minimisation
  • all therapeutic products containing material from humans or ruminants are assessed for TSE safety before they are allowed to be supplied in Australia
  • all materials from ruminants (including cattle, sheep, goats and deer) should be sourced from countries with the lowest possible TSE risk, using the current world categorisation of countries (unless a justification is provided that the TGA considers acceptable)
  • all materials from ruminants must come from animals certified 'fit for human consumption'
  • all ruminant tissues used in therapeutic products must be from the lowest risk tissues (unless a justification is provided that the TGA considers acceptable)
  • consideration is also given to the manufacturing process which for many ingredients derived from ruminants have been validated for removal or inactivation of TSE agents

Blood product safety

Changes to the TGA policy on TSE does not affect blood donations. The criteria for blood donations, in regards to TSE, have not changed.

Any blood products imported from overseas manufacturers must comply with the Australian donor criteria as well. These measures were introduced to prevent the potential transmission of variant Creutzfeldt Jakob Disease, which is the human equivalent of mad cow disease, thought to be transmitted through blood transfusions.

The Australian Red Cross Blood Service can provide further information on therestrictions that apply to blood donors, in relation to TSE.

More information about TSEs

More information is available about the worldwide regulation of TSEs: