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New home for the EU's pharmaceutical quality standards

By Peter Mansell , 02-Apr-2007

The Council of Europe has inaugurated new premises for its European Directorate for the Quality of Medicines & HealthCare (EDQM) in Strasbourg.

The move into a larger building at 7 allée Kastner reflects the EDQM's expanding mandate and will ease interaction with its parent body by bringing the Directorate close to the headquarters of the Council.


The EDQM can now call on some 19,500sq. m of floor space, divided into three areas: a meetings and communications section, where the Directorate will host expert group discussions, meetings of the European Pharmacopoeia, scientific conferences and training course for Pharmacopoeia users; laboratory space and the EDQM's Standards Production Centre, where all analytical studies are conducted and the European Pharmacopoeia's reference substances and preparations are produced; and an administrative area housing the Directorate's 150-strong staff.


Building costs for the EDQM's new base were around €35 million. The move indicates how far the Directorate has travelled from its roots in the signature of the European Pharmacopoeia Convention in 1964, when eight European Union member states - Belgium, France, Germany, Italy, Luxembourg, the Netherlands, Switzerland and the United Kingdom - decided to harmonise their national pharmacopoeias, the monographs specifying the exact composition of the substances used to make up medicines.


Today the European Pharmacopoeia still prepares, edits and updates monographs but its role has expanded to cover all aspects of quality control for medicines, from manufacture through to marketing. The EDQM, which was set up in 1995, is responsible for the Technical Secretariat of the European Pharmacopoeia and, latterly, for co-ordinating a network of Official Medicines Control Laboratories, with the aim of facilitating mutual recognition of national quality control tests on pharmaceuticals.


Last December, the EDQM's remit was extended to setting standards for the quality and safety of transplanted organs, substances of human origin, transfused blood and blood derivatives (hence the "& Healthcare" added to the organisation's original name). Future challenges will include quality standards for drugs used in genetic or cell therapy and for products outside the European Union traditions, such as traditional Chinese medicine.


The EDQM's geographical scope has also widened enormously. It now has 37 member states that are parties to the Convention on the Elaboration of a European Pharmacopoeia, as well as 20 observer countries spanning Central and Eastern Europe, North and South America, North Africa, the Asia Pacific region and the Middle East.


At its 127th session recently, the European Pharmacopoeia Commission elected Professor Hendrick Jan de Jong as its new chair for a term running from June 2007 to June 2010. Professor de Jong, who will succeed Dr Michael Morris as the 15th chair of the Commission, is a Dutch national who has been vice-chair of the European Pharmacopoeia Commission since June 2004.

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