The EDQM (Council of Europe) is a key European Organisation involved in Harmonisation & Co-ordination of Standardisation, Regulation & Quality Control of Medicines, Blood Transfusion and Organ Transplantation.
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The European Directorate for the Quality of Medicines & HealthCare protects and promotes public and animal health in Europe. You can find out what's new, information about the EDQM and how to contact us.
Since December 2006, the EDQM is in charge of the Council of Europe’s activities on quality of blood transfusion and organ transplantation. Learn about the news and general information on the activities.
Better understand the work of the European Pharmacopoeia and learn how to participate in the European Biological Standardisation Programme.
A major tool for guaranteeing the quality of substances for pharmaceutical use in the context of developing world trade. Discover the news and general information, how to submit new applications, revisions & renewals, how to apply for technical advice & one to one meeting and be informed about its legal status & background and inspection.
Since 1994, several coordinated European control programmes have been set up. These activities are covered by the Official Medicines Control Laboratories Network (OMCL Network), including quality assurance activities. Programmes such as proficiency testing studies (PTS) are also organised by the EDQM.
Discover the full range of publications, reference standards and services provided by the EDQM: the European Pharmacopoeia 6th Edition and other publications. EDQM Reference Standards and WHO ISA Standards. CombiStats and other services.
Potentially genotoxic impurities & PhEur monographs
(01/07/08) Policy paper for dealing with potentially genotoxic impurities to be applied during elaboration and revision of monographs.
News and General InformationOMCL Quality Assurance Guidelines
A new annex of the OMCL Network guideline 'Qualification of equipment' was adopted at the OMCL annual meeting held in June 2008.
Quality Assurance Activities Guidelines2nd Workshop on the Characterisation of Heparin Products
(30/06/08) This workshop was jointly organised by the EDQM, the NIBSC and the USP to discuss the characterisation and quality control of heparins.
What's new?European Pharmacopoeia adopts revision of heparin monographs
Monographs to be implemented on 15 July 2008
(27/06/08) The PhEur Commission adopts the revision of two heparin monographs, namely Heparin calcium (0332) and Heparin sodium (0333).
News and General Information13th Annual Meeting of OMCL Network
(20/06/08) The EDQM held its 13th Annual Meeting of the Official Medicines Control Laboratory (OMCL) Network in Strasbourg from 2 to 6 June 2008.
News and General InformationCertification: Providing samples & a new system for revision/renewal of CEPs
(18/06/08) The policy concerning Certification samples and the system for revision/renewal of CEPs will change from 1st July 2008.
News & General InformationCertification: Procedure for the validation of new applications
(16/06/08) Document released presents the measures put in place in 2007 for the validation of new applications and how to avoid the blockage of an application at receipt.
News & General InformationInternational Harmonisation: Pharmacopoeial Discussion Group Activities
(10/06/08) The last meeting of the PDG was held in Portland, USA.
International HarmonisationPharmeuropa 20.3 July 2008
(09/06/08) NEW: List of contents now available under 'Downloads'.
For more information on how to order, please click below.
Certification: Notice to holders of CEPs for heparin or enoxaparin
The EDQM has published a notice to the attention of holders of CEPs for heparin or enoxaparin.
News & General InformationEDQM saddened by death of Peter Castle, Secretary to the European Pharmacopoeia Commission
(14/05/08) The EDQM with great sadness announces the death of Peter Castle, Secretary to the European Pharmacopoeia Commission and Head of the European Pharmacopoeia Department.
What's new?EDQM participates in an international meeting on heparins
(13/05/08) The EDQM participated in a recent meeting organised by the United States FDA to state the European Pharmacopoeia’s position and to share its experience on the current issues concerning the quality of heparins.
What's new?Meeting held between the EDQM and the Indian authorities
Top level meeting held between the EDQM and the Indian authorities to strengthen collaborative efforts to improve the quality and safety of medicines in Europe and India.
What's new?List of Standard Terms
From 28/04/08 the EDQM will only be selling an online version. Customers purchasing the online version will be provided with an EPID reference to gain access to the database. The online version is also available FREE to customers who have already purchased the print version of the 5th Edition 2004.
Standard TermsCombining forces to protect patients from counterfeit medicines and pharmaceutical crime
A model for a network and single points of contact (SPOCs) across disciplines and borders
News and General InformationInternational Symposium on Pharmaceutical Reference Standards
(11/02/08) Programme of the international symposium is now available.
Pharmaceutical Reference Standards Symposium
Draft programme now available to download.
Pharmaceutical Reference Standards, Strasbourg, FrancePotentially genotoxic impurities & PhEur monographs
(01/07/08) Policy paper for dealing with potentially genotoxic impurities to be applied during elaboration and revision of monographs.
News and General InformationOMCL Quality Assurance Guidelines
A new annex of the OMCL Network guideline 'Qualification of equipment' was adopted at the OMCL annual meeting held in June 2008.
Quality Assurance Activities Guidelines2nd Workshop on the Characterisation of Heparin Products
(30/06/08) This workshop was jointly organised by the EDQM, the NIBSC and the USP to discuss the characterisation and quality control of heparins.
What's new?European Pharmacopoeia adopts revision of heparin monographs
Monographs to be implemented on 15 July 2008
(27/06/08) The PhEur Commission adopts the revision of two heparin monographs, namely Heparin calcium (0332) and Heparin sodium (0333).
News and General Information13th Annual Meeting of OMCL Network
(20/06/08) The EDQM held its 13th Annual Meeting of the Official Medicines Control Laboratory (OMCL) Network in Strasbourg from 2 to 6 June 2008.
News and General InformationCertification: Providing samples & a new system for revision/renewal of CEPs
(18/06/08) The policy concerning Certification samples and the system for revision/renewal of CEPs will change from 1st July 2008.
News & General InformationCertification: Procedure for the validation of new applications
(16/06/08) Document released presents the measures put in place in 2007 for the validation of new applications and how to avoid the blockage of an application at receipt.
News & General InformationInternational Harmonisation: Pharmacopoeial Discussion Group Activities
(10/06/08) The last meeting of the PDG was held in Portland, USA.
International HarmonisationPharmeuropa 20.3 July 2008
(09/06/08) NEW: List of contents now available under 'Downloads'.
For more information on how to order, please click below.
Certification: Notice to holders of CEPs for heparin or enoxaparin
The EDQM has published a notice to the attention of holders of CEPs for heparin or enoxaparin.
News & General InformationEDQM saddened by death of Peter Castle, Secretary to the European Pharmacopoeia Commission
(14/05/08) The EDQM with great sadness announces the death of Peter Castle, Secretary to the European Pharmacopoeia Commission and Head of the European Pharmacopoeia Department.
What's new?EDQM participates in an international meeting on heparins
(13/05/08) The EDQM participated in a recent meeting organised by the United States FDA to state the European Pharmacopoeia’s position and to share its experience on the current issues concerning the quality of heparins.
What's new?Meeting held between the EDQM and the Indian authorities
Top level meeting held between the EDQM and the Indian authorities to strengthen collaborative efforts to improve the quality and safety of medicines in Europe and India.
What's new?List of Standard Terms
From 28/04/08 the EDQM will only be selling an online version. Customers purchasing the online version will be provided with an EPID reference to gain access to the database. The online version is also available FREE to customers who have already purchased the print version of the 5th Edition 2004.
Standard TermsCombining forces to protect patients from counterfeit medicines and pharmaceutical crime
A model for a network and single points of contact (SPOCs) across disciplines and borders
News and General InformationEuropean Pharmacopoeia 6th Edition Training Session
1-2 July 2008, Strasbourg, France
International Symposium on Pharmaceutical Reference Standards
(11/02/08) Programme of the international symposium is now available.
Pharmaceutical Reference Standards Symposium
Draft programme now available to download.
Pharmaceutical Reference Standards, Strasbourg, France
7 allée Kastner, CS 30026, F67081 Strasbourg, France - Tel. +33 (0)3 88 41 30 30 - Fax +33 (0)3 88 41 27 71
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