Join us online to celebrate the European Day for Organ Donation and Transplantation on 9 October 2021! #JustSayYesEODD

EDQM 30/09/2021 Strasbourg, France

Organ, tissue and cell transplantation is one of the great medical success stories of modern times. In many cases, it is the only life-saving treatment for patients with end-stage organ failure, devastating burn injuries or blood cancers, and in many others it can significantly improve the...

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Risk of the presence of mutagenic azido impurities in losartan active substance

EDQM 29/09/2021 Strasbourg, France

In April 2021, the European Directorate for the Quality of Medicines & HealthCare (EDQM) reported that it had received information about the possible presence of potentially mutagenic azido impurities in certain sartan active substances. Investigations requested by the EDQM indicated that only a...

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Certification of suitability: revised terms of reference and rules of procedure

EDQM 27/09/2021 Strasbourg, France

A revised version of the terms of reference and rules of procedure for the Certification of suitability to the monographs of the European Pharmacopoeia (CEP) procedure has been adopted by the Certification Steering Committee and is available on the website of the European Directorate for the...

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New EDQM IT tool for the management of CEP activities – Impact for CEP applicants and CEP holders

EDQM 24/09/2021 Strasbourg, France

From the beginning of October 2021, the CEP Department (DCEP) of the European Directorate for the Quality of Medicines & HealthCare (EDQM) will use a new IT application for the management of its activities. The implementation of this tool will entail certain changes in the way the EDQM...

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OMCL Annual Meeting 2021: European Quality Control Programmes and Strategies for Medicines

EDQM 22/09/2021 Strasbourg, France

The 26th Annual Meeting of the European Network of Official Medicines Control Laboratories (OMCLs) took place from 6 to 10 September 2021 and was held virtually due to the ongoing pandemic situation. The meeting, organised by the European Directorate for the Quality of Medicines & HealthCare...

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Newsletter Transplant 2021 now available

EDQM 21/09/2021 STRASBOURG, FRANCE

The 2021 edition of the Newsletter Transplant has just been published. It summarises comprehensive information and data for 2020 from 82 countries worldwide on donation and transplantation activities, management of waiting lists, organ donation refusals and authorised centres for transplantation...

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Certification monthly report of activities: August 2021

EDQM 14/09/2021 Strasbourg, France

The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. August 2021 Certification Monthly Report For more information, access the Certification Database.

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2 new Ph. Eur. reference standards and 15 replacement batches released in August 2021

06/09/2021 Strasbourg, France

New Ph. Eur. reference standards Replacement batches for Ph. Eur. reference standards Removal Future removal Change of sales units Information on change of price Change of EDQM storage/shipping conditions See also: Content of the Ph. Eur. RS catalogue How to place an RS order   The European...

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Publication of a new general chapter on balances in European Pharmacopoeia Supplement 10.6

EDQM 03/09/2021 Strasbourg, France

At its 168th session (November 2020), the European Pharmacopoeia (Ph. Eur.) Commission adopted a new general chapter: Balances for analytical purposes (2.1.7). This new chapter is included in Supplement 10.6 of the Ph. Eur., published in July 2021. This addition to section 2.1. Apparatus fills a...

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6 new reference standards and 16 replacement batches released in July 2021

EDQM 05/08/2021 Strasbourg, France

New Ph. Eur. reference standards Replacement batches for Ph. Eur. reference standards Removal Future removal Change of sales units Information on change of price Change of EDQM storage/shipping conditions See also: Content of the Ph. Eur. RS catalogue How to place an RS order   The EDQM announces...

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New publication on an EDQM Biological Standardisation Programme study for standardisation of allergen products

EDQM 03/08/2021 Strasbourg, France

Following the successful completion of the BSP090 study on recombinant major allergens, in collaboration with project leaders from the Paul-Ehrlich-Institut, an article on one of the major study outcomes “Validation of a candidate European Pharmacopoeia standard method for quantification of major...

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Preventing food contamination: new multi-analyte methods for the determination of substances migrating from printing inks to food or food simulants

EDQM 28/07/2021 Strasbourg, France

The quality and safety of materials and articles which come into contact with food need to be controlled. The European Directorate for the Quality of Medicines & HealthCare (EDQM) therefore develops guidelines for such items through the work of the European Committee for Food Contact Materials...

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CEP holders invited to comment on draft monographs published in Pharmeuropa 33.3

EDQM 15/07/2021 Strasbourg, France

CEP holders are requested to consult the list of substances for which draft revised monographs of the European Pharmacopoeia (Ph. Eur.) have been published in Pharmeuropa 33.3. The table below lists the substances affected by these revisions and for which CEPs have been granted.

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Implementation of the European Pharmacopoeia Supplement 10.6 – Notification for CEP holders

EDQM 13/07/2021 Strasbourg, France

Supplement 10.6 of the European Pharmacopoeia (Ph. Eur) is now available. CEP holders are invited to update their applications according to the revised monographs that will be implemented on 1 January 2022, and to follow the instructions given below. The table at the end of this announcement...

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New monograph on a single-source anti-TNF-alpha monoclonal antibody released for public consultation in Pharmeuropa

EDQM 12/07/2021 Strasbourg, France

A new draft monograph, Golimumab concentrated solution (3103), has been published in this quarter’s issue of Pharmeuropa (33.3), the European Pharmacopoeia (Ph. Eur.) online forum for comment. Following the adoption and publication of the monographs for Etanercept (2895) and Infliximab...

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Revised general chapter 5.21 Chemometric methods applied to analytical data published for public comment in Pharmeuropa

EDQM 09/07/2021 Strasbourg, France

The revised general chapter Chemometric methods applied to analytical data (5.21) has been published in this quarter’s issue of Pharmeuropa (33.3), the European Pharmacopoeia (Ph. Eur.) online forum, for comment. This general chapter, published for information, is an introduction to the use of...

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Certification monthly report of activities: June 2021

EDQM 08/07/2021 Strasbourg, France

The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. June 2021 Certification Monthly Report For more information, access the Certification Database.

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9 new reference standards and 22 replacement batches released in June 2021

EDQM 07/07/2021 Strasbourg, France

The EDQM announces the availability of 9 new European Pharmacopoeia (Ph. Eur.) reference standards and 22 replacement batches for Ph. Eur. reference standards.

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Highlights of 2020 – EDQM annual report now available

EDQM 06/07/2021 Strasbourg, France

The 2020 annual report of the European Directorate for the Quality of Medicines & HealthCare (EDQM) is now available, providing a comprehensive overview of its activities, achievements and events. While the year 2020 will long be remembered for the COVID-19 pandemic almost bringing the world to a...

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EDQM fertility preservation guide now available

EDQM 05/07/2021 Strasbourg, France

Personal choices regarding parenthood can be affected by disease and other life events that might have an impact on a person’s fertility. Making informed decisions in this highly personal area is of great importance to the health and well-being of individuals everywhere. The European Directorate...

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