Biological Standardisation Programme (BSP)
Background & Mission

The Main Goals of the European BSP are:

• elaboration of European reference substances and working standards for biologicals;
• standardisation of test methods for the quality control of biologicals;
• elaboration of alternative methods for the quality control of biologicals to apply the 3Rs concept (Refine, Reduce, Replace animal experiments); and
  
• contribution to the international harmonisation (ICH, VICH) in the field of biologicals.

Exemplary Co-Operation Between International Organisations

An agreement for co-operation was signed in 1991 between the Commission of the European Communities and the Council of Europe to provide logistical and scientific assistance for activities related to the testing of biological medicines, in particular vaccines and blood products. This agreement covers research programmes implemented under a Steering Committee with the Secretariat being provided by the EDQM (DBO). These programmes are financed by a specific budget contributed by the two contracting parties. Non-EU countries may also take part in the financing of the programmes. The signature of this contract has given new impetus to the activities in the biological field by complementing the work performed by the relevant groups of experts of the European Pharmacopoeia Commission. Since then, the Commission of the European Communities has officially become a party to the Convention on the Elaboration of a European Pharmacopoeia and has been continuing to provide financial contribution every year to the continuation and growth of biological standardisation activities within the EDQM.

Moreover, whenever possible, European studies are co-ordinated with those being carried out or planned by the World Health Organisation (WHO) and the Food and Drug Administration (FDA) of the United States of America.

Reference Standards and Development of Test Methods

The establishment of European working standards is part of the authorised scientific programmes. Consequently, the titres and potencies of biological products will be expressed with respect to the same reference standard. The existence of reference standards recognised throughout Europe will enable national control agencies and manufacturers to avoid costly duplications of work on secondary standards, which could otherwise lead to disagreements and problems of mutual recognition. In recent years, the European Pharmacopoeia Commission has elaborated a policy of replacing the use of animals in quality control testing of medicines, in parallel with the application of the corresponding Convention of the Council of Europe. To this end, the Council of Europe, represented by the EDQM, and the Commission of the European Communities are now working on an extensive standardisation programme to set up collaborative studies to: apply the 3Rs concept to replace the use of laboratory animals.