Homepage / The European Pharmacopoeia / Biological Standardisation Programme / BSP Structure
The Stakeholders
- The Ph. Eur. Commission and Groups of Experts
- The European network of OMCLs
- The European Commission (EU)
- The CHMP/CVMP of the EMEA and their relevant Working Parties
The European Directorate for the Quality of Medicines & HealthCare
EDQM/DBO provides the secretarial support of the BSP and is charged with administration, co-ordination and conduction of the programme.
The Steering Committee (SC)
The SC is composed of 11 members and 2 observers. Members are:
- the actual chairs of the Ph. Eur. Groups of Experts dealing with biologicals (Groups 6, 6B, 15, 15V).
- the actual chairs of the CHMP-Biotechnology WP and the CVMP-Immunologicals WP or their replacements as nominated by CHMP/CVMP. They take up their duty at the first SC meeting following their appointment.
- one representative of EMEA
- one representative of the European Commission
- two specialists in the field of biologicals for human use (in general one for vaccines and one for blood products) and one specialist for biologicals for veterinary use. They are co-opted by the SC.
Observers: one representative of the Biologicals division of WHO and one representative of a WHO collaborative centre nominated by WHO.
The SC elects a Chair among its members for an initial term of three years with the possibility for re-election for one consecutive term.
The role of the Steering Committee is:
- to decide, in consultation with the stakeholders, the start of new BSP projects and to nominate the PL or SA
- to monitor the progress of the BSP projects and to support them scientifically
- to approve the final project reports
- to advise the Ph. Eur. Commission on questions concerning standardisation of biologicals
Regular meetings of the SC are held twice yearly, in general in January and June/July. If considered urgent, reports may be approved by correspondence.
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