European Commission advises on preventing BSE spread through medicines

The European Commission is consulting on new draft guidance advising the pharmaceutical industry on preventing the spread of BSE and related diseases to humans when using animal by-products in medicines, such as making capsules.

Materials such as gelatin and bovine blood derivatives are focal points of this advice. It insists on sourcing animals far from any known BSE outbreaks; avoiding the use of animal materials especially associated with BSE (plus procedures to avoid contamination with such animal parts); and establishing assurance systems to ensure traceability and product quality, among other recommendations.

The guidelines stress: "Since the use of animal-derived materials is unavoidable for the production of some medicinal products and that complete elimination of risk at source is rarely possible, the measures taken to manage the risk of transmitting animal TSEs [BSE and related diseases] via medicinal products represent risk minimisation rather than risk elimination."

Comments should be sent to entr-gmp@ec.europa.eu and tse.guideline.bwp@emea.europa.eu by June 30.