Spec. Issue 2006 - Article Summary

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Contributions of the European OMCL network and biological standardisation programme to animal welfare

Marie-Emmanuelle Behr-Gross and Jean-Marc Spieser
European Directorate for the Quality of Medicines, Council of Europe, Strasbourg, France
Summary
In 1991 a contractual co-operation in harmonising medicines control started between the European Union and the European Directorate for the Quality of Medicines (EDQM)-Council of Europe (CoE): The EDQM has been charged to co-ordinate a network of national Official Medicines Control Laboratories (OMCL) and a research programme referred to as Biological Standardisation Programme (BSP). In line with the CoE convention on the protection of animals, the BSP establishes European Pharmacopoeia (Ph. Eur.) standards for biomedicines quality control with a special emphasis on 3Rs alternative methods. Sixteen projects on vaccines and one on blood products have been initiated in this field. The programme, run in the spirit of international harmonisation, involves the OMCL network, public and private sector medicines control laboratories in Europe, the Americas, Asia and Australia and non-European standardisation bodies. Completed projects on Newcastle disease and clostridial veterinary vaccines and on diphtheria and tetanus human vaccines led to new Ph. Eur. general methods and standards, thus showing that the BSP promotes regulatory acceptance of alternatives. Further studies deal with botulinum toxin, vaccines for human use (inactivated poliomyelitis virus, hepatitis A, hepatitis B and pertussis) and tetanus immunoglobulin. For the future, the programme hopes to benefit from synergies between fundamental, medical and pharmaceutical sciences experts for promoting animal welfare aspects in control whilst guaranteeing quality, safety and efficacy to biomedicines potential users.

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