Note for Guidance on minimising the Risk of transmitting Animal Spongiform Encephalopathy Agents via human and veterinary Medicinal Products

On 5 March, the European Commission published the third revision of the Note for guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products. This revison is made in consideration of the current development in sciences of TSE and the evolving situation regarding Bovine Spongiform Encephalopathy (BSE) across the world.

The scope of this guidance includes TSE relevant animals like cattle, sheep, goats and animals that are naturally susceptible to infection with transmissible spongiform encephalopathy agents or susceptible to infection through the oral route other than humans  and non-human primates are defined as ‘TSE-relevant animal species. Furthermore it includes materials derived from ‘TSE-relevant animal species’ that are used for the preparation of active substances, excipients and adjuvants, and raw and starting materials and reagents used in production (e.g. bovine serum albumin, enzymes, culture media including those used to prepare working cell banks, or new master cell banks for medicinal products which are subject to a new Marketing Authorisation). Beyond that Seed lots, cell banks and routine fermentation/ production are concerned.

For the classification of countries or regions according to their BSE risk, the revised Note for Guidance will make reference to the rules laid down by the World Organisation for Animal Health (OIE), replacing the previous GBR classification. Nevertheless, for countries that were classified according to the GBR criteria but not yet according to the OIE criteria, the existing GBR classification should apply, provided that there is no evidence of significant change in their BSE risk.

This note for guidance supersedes the previous revision from 2004 and and the proposed application date is 1 July 2011.

Also read the complete note for guidance.

Please pay attention to ECA`s Education Course " Virus and TSE safety made simple" in Vienna, Austria, from 27-28 September 2011 .This course will give you a scientifically sound introduction into the field of Virus and TSE safety and the impact on the pharmaceutical industry.You get an overview about relevant aspects of virology, you understand the impact on the manufacture of biopharmaceuticals/biologics and you will get familiar with current detection, inactivation and removal techniques and the regulatory background.

Axel H. Schroeder
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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