European Directorate for the Quality of Medicines
Encyclopedia
The European Directorate for the Quality of Medicines (EDQM) of the Council of Europe
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 numbered 220 in 2010 and 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, USB Key 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
(EMA, London).
Since 2007, the EDQM has expanded its responsibilities to include new areas: blood transfusion
, organ transplantation, cosmetics and food packaging material. 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.
Council of Europe
The Council of Europe is an international organisation promoting co-operation between all countries of Europe in the areas of legal standards, human rights, democratic development, the rule of law and cultural co-operation...
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
European Pharmacopoeia
The European Pharmacopoeia of the Council of Europe is a pharmacopoeia, listing a wide range of active substances and excipients used to prepare pharmaceutical products in Europe...
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
Strasbourg
Strasbourg is the capital and principal city of the Alsace region in eastern France and is the official seat of the European Parliament. Located close to the border with Germany, it is the capital of the Bas-Rhin département. The city and the region of Alsace are historically German-speaking,...
(France
France
The French Republic , The French Republic , The French Republic , (commonly known as France , is a unitary semi-presidential republic in Western Europe with several overseas territories and islands located on other continents and in the Indian, Pacific, and Atlantic oceans. Metropolitan France...
), the seat of the Council of Europe
Council of Europe
The Council of Europe is an international organisation promoting co-operation between all countries of Europe in the areas of legal standards, human rights, democratic development, the rule of law and cultural co-operation...
to which it belongs.
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, USB Key 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
European Union
The European Union is an economic and political union of 27 independent member states which are located primarily in Europe. The EU traces its origins from the European Coal and Steel Community and the European Economic Community , formed by six countries in 1958...
(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
Antibiotic
An antibacterial is a compound or substance that kills or slows down the growth of bacteria.The term is often used synonymously with the term antibiotic; today, however, with increased knowledge of the causative agents of various infectious diseases, antibiotic has come to denote a broader range of...
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
European Medicines Agency
The European Medicines Agency is a European agency for the evaluation of medicinal products. From 1995 to 2004, the European Medicines Agency was known as European Agency for the Evaluation of Medicinal Products.Roughly parallel to the U.S...
(EMA, London).
Since 2007, the EDQM has expanded its responsibilities to include new areas: blood transfusion
Blood transfusion
Blood transfusion is the process of receiving blood products into one's circulation intravenously. Transfusions are used in a variety of medical conditions to replace lost components of the blood...
, organ transplantation, cosmetics and food packaging material. 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.