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European Directorate for the Quality of Medicines
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The European Directorate for the Quality of Medicines of the Council of Europe (EDQM) came into being in its current form in 1996. It consists of the Technical Secretariat of the European Pharmacopoeia Commission long referred to as the European Pharmacopoeia set up in 1964 by the European Pharmacopoeia Convention, and other, more recent services which provide support activities related to use of the European Pharmacopoeia such as the certification of suitability of monographs and the European Network of Official Control Laboratories (OMCL) for medicines for human and veterinary use (set up in 1995).
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The European Directorate for the Quality of Medicines of the Council of Europe (EDQM) came into being in its current form in 1996. It consists of the Technical Secretariat of the European Pharmacopoeia Commission long referred to as the European Pharmacopoeia set up in 1964 by the European Pharmacopoeia Convention, and other, more recent services which provide support activities related to use of the European Pharmacopoeia such as the certification of suitability of monographs and the European Network of Official Control Laboratories (OMCL) for medicines for human and veterinary use (set up in 1995). It is based in Strasbourg (France), the seat of the Council of Europe to which it belongs.
The EDQM staff (180 July 2007) consists of pharmacists, chemists, biochemists, biologists, laboratory technicians, pharmaceutical technicians, specialised secretaries, computer engineers and programmers, specialised translators, statisticians, archivists as well as administrative and financial support staff. Altogether, the employess are spread across about 20 different nationalities.
The EDQM is responsible for the Technical Secretariat of the European Pharmacopoeia Commission. This Technical Secretariat is in charge of:
• preparing and publishing adopted texts (printed version, CD-ROM and Internet) and distributing the European Pharmacopoeia and other publications;
• checking the texts experimentally in the laboratory; the laboratory also carries out analytical studies and organises collaborative studies to establish European Pharmacopoeia
chemical or biological reference substances or preparations;
• preparing, managing and dispatching European Pharmacopoeia reference substances;
• organising regularly congresses on new scientific and technical subjects, as well as seminars and training sessions on subjects related to the European Pharmacopoeia.
The EDQM is also responsible for organising activities related to the procedure for the certification of suitability of European Pharmacopoeia monographs The new Directive of the European Union (Directive 2003/63/EC) makes it obligatory for marketing authorisation dossiers for medicines to refer to the specific and general monographs of the European Pharmacopoeia; it also mentions the use of certificates of suitability of monographs of the European Pharmacopoeia in applications for marketing authorisation to demonstrate that the substances used by the manufacturers comply with specifications. The EDQM provides administrative co-ordination and a secretariat for this procedure; more than 80 national experts participate as assessors and rapporteurs in the evaluations of the dossiers received (between 250 and 400 dossiers per year).
The EDQM is also responsible for a number of activities, in collaboration with the EU, related to Surveillance of Pharmaceutical Products marketed and distributed in Europe. As part of its surveillance activities for marketed medicines, the EDQM co-ordinates the European Network of Official Medicines Control Laboratories (OMCL); this activity was set up at the request of the EU. More than 100 Official Control Laboratories in nearly 40 countries collaborate in this network. This activity is essential in Europe to facilitate mutual recognition between countries of quality control tests carried out on medicines and ensures that patients receive the same quality of pharmaceutical products.
The EDQM organises general market surveillance studies on products marketed throughout Europe (36 countries). For example, the analysis of the quality of antibiotic granules and powders, herbal preparations, etc. It also organises testing of a number of biological products (blood derivatives and vaccines) with elaboration by and for OMCLs of European test procedures for batch release of such products. Finally, it organises market surveillance of products that have received a centralised Community Marketing Authorisation according to a programme of work set by the European Medicines Agency (EMEA, London).
Since 2007, the EDQM has expanded its responsibilities to include two new areas: blood transfusion and organ transplantation. It is responsible for the setting of standards for the quality and safety of organs and substances of human origins, blood and blood derivatives. The name has consequently been changed to European Directorate for the Quality of Medicines & Healthcare. It retains the acronym EDQM.
The current director of the EDQM is Dr Susanne Keitel (German), who took over from Dr Agnès Artiges (French) on 1 October 2007.
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