Recently released: 2 new Ph. Eur. Reference standards Zoledronic acid monohydrate and Infliximab BRP, as well as 16 replacement batches

EDQM 24/10/2018 Strasbourg, France

2 new Ph. Eur. Reference Standards and 16 replacement batches Y0002020 Zoledronic acid monohydrate and Y0002110 Infliximab BRP Y0000740 Adrenaline impurity mixture, T1410000 Tiabendazole , E2250000 Ethosuximide impurity A, R0800000 Rifampicin quinone , Y0000026 Sumatriptan impurity mixture,...

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Update on the review of CEP applications for sartans and the availability of test methods for nitrosamines

EDQM 17/10/2018 Strasbourg, France

Following the detection of the impurity NDMA (N-nitrosodimethylamine) in valsartan at the end of June, the EDQM has conducted a complete review of the manufacturing information submitted in all Certificate of suitability (CEP) applications for valsartan and other structurally related active...

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Be ready to save lives, become a superhero! Say yes to organ, tissue and cell donation!

EDQM 12/10/2018 Strasbourg, France

The European Day for Organ Donation and Transplantation (EODD), established by the Council of Europe in 1996, will be officially celebrated in Chisinau (Republic of Moldova) on 13 October. Organ transplantation is one of the great medical success stories of the 20th century, over the past few...

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New OMCL method for simultaneous determination of NDMA and NDEA in sartans

EDQM 11/10/2018 Strasbourg, France

Since early July 2018 Official Medicines Control Laboratories (OMCLs) of the General European OMCL Network (GEON) have been involved in investigations and actions to address the issues related to the detection of N-nitrosodimethylamine (NDMA) potentially present in valsartan and other sartan...

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Quality of gene therapy products: EDQM listens to stakeholders’ needs

EDQM 08/10/2018 Strasbourg, France

The EDQM is the Directorate of the Council of Europe responsible for supporting the basic human right of access to good quality medicines and health care in Europe. With its European Pharmacopoeia (Ph. Eur.), the EDQM sets requirements for the quality of medicines, including those in the field...

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EDQM launches public consultation on first pilot monographs for European Paediatric Formulary

EDQM 05/10/2018 Strasbourg, France

The EDQM has launched a public consultation on the first two pilot monographs and on two general texts for its European Paediatric Formulary. Pharmacists and paediatricians across Europe are called to provide their feedback on the draft monographs on Hydrochlorothiazide oral solution and on...

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EDQM issues recommendations for sustainable, cost-effective quality management in Europe’s blood sector

EDQM 28/09/2018 Strasbourg, France

The EDQM has issued a set of recommendations for the development of cost-effective and sustainable Quality Management Systems (QMSs) in Blood Establishments (BEs) across Europe. The document follows on from the European Conference on “Sharing best practices: Quality Risk Management, Change...

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New Council of Europe’s EDQM publication on the donation of oocytes

EDQM 27/09/2018

The European Committee on Organ Transplantation (CD-P-TO) in charge of organ transplantation activities at the EDQM, in collaboration with the European Society of Human Reproduction and Embryology, has published a new guide entitled “Donation of oocytes: A guide for women to support informed...

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Just released: Newsletter Transplant 2018

EDQM 21/09/2018 Strasbourg, France

The Newsletter Transplant provides 2017 figures and analysis of international trends concerning deceased and living donation, overall number of transplantations and transplantations by organ type, management of waiting lists, organ donation refusals and authorised centres for transplantation...

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OMCLs release three methods for determination of NDMA in sartans

EDQM 21/09/2018 Strasbourg, France

Since early July 2018, OMCLs have been involved in investigations and actions to address the issues related to the detection of N-nitrosodimethylamine (NDMA) in valsartan. The Network has meanwhile developed methods for the specific testing of nitrosamines in sartans on the basis different...

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Chinese Pharmacopoeia illustrates new framework for excipients

EDQM 18/09/2018 Strasbourg, France

The EDQM has provided a platform for European and international medicine manufacturers to discuss new regulatory approaches in China on pharmaceutical excipients selection and quality control. During a workshop on 18 September in Strasbourg, the Chinese Pharmacopoeia (ChP) delivered the most...

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Update on detection of nitrosamines in valsartan and validated testing method

EDQM 14/09/2018 Strasbourg, France

The EDQM continues investigating and defining actions to address the presence of all kinds of nitrosamines, including NDMA and NDEA in valsartan and other sartans which may be affected. As mentioned in a previous press release, the EDQM has contacted those manufacturers holding CEPs (Certificates...

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9 new Ph. Eur. Reference Standards released in August 2018

EDQM 07/09/2018 Strasbourg, France

New Ph. Eur. Reference Standards Y0002037 Chlorobutanol CRS Y0002039 Benzathine phenoxymethylpenicillin for system suitability CRS Y0001999 Colistin for system suitability CRS Y0002047 Infliximab CRS Y0002024 Plastic additive 27 CRS Y0002007 Sulfobutylbetadex impurity B CRS Y0002028 ...

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Update on EDQM’s actions following detection of impurity in valsartan

EDQM 28/08/2018 Strasbourg, France

The EDQM is continuing the investigations and actions which started in July 2018 to address the issue related to the detection of N-nitrosodimethylamine (NDMA) in a source of active substance valsartan.

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Ph. Eur. monograph for Octreotide (2414) – publication postponed

EDQM 10/08/2018 Strasbourg, France

The monograph for Octreotide (2414) – adopted by the Ph. Eur. Commission at its 160th Session in March 2018 – will not be published in Ph. Eur. Supplement 9.7 (publication date October 2018); as a consequence, the implementation date of the monograph will not be 1st April 2019. This decision to...

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EDQM’s actions to evaluate impact of impurity in active substance valsartan

EDQM 27/07/2018 Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare (EDQM) is aware of a quality defect related to an impurity in the active substance valsartan used in medicines to treat high blood pressure marketed in Europe. Earlier this month, a pan-European alert system has been triggered by...

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Pharmeuropa issue 30.3 is complete. Comments before 30 September 2018

EDQM 17/07/2018 Strasbourg, France

Pharmeuropa issue 30.3 is complete: you have until 30 September 2018 to have your say and comment on the draft Ph. Eur. texts. 28 draft texts have been released for comment. Discover in advance the draft texts of the European Pharmacopoeia to test analytical methods and to have your comments...

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4 elemental impurity chemical reference standards (CRS) available in the EDQM CRS catalogue

EDQM 17/07/2018 Strasbourg, France

Lead solution CRS , cadmium solution CRS, mercury solution CRS and arsenic solution CRS have been recently added in EDQM RS Portfolio. These “Class 1” elements occurring in nature are amongst the greatest potential sources of elemental contamination in medicinal products and substances for...

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CEP document revised: “Implementation of ICH Q3D in the Certification Procedure”

EDQM 17/07/2018 Strasbourg, France

The EDQM document “Implementation of ICH Q3D in the Certification Procedure” has been revised based on experience gained by EDQM since the initial implementation of the policy. Its implementation date is the 1st September 2018. Link to the document: HERE

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Falsification of medical products: a revised version of Know-X database is launched

EDQM 16/07/2018 Strasbourg, France

The EDQM has launched a revised version of its Know-X database. This project jointly carried out by the Official Medicines Control Laboratories (OMCL) Network and the EDQM’s Committee of Experts on Minimising Public Health Risks Posed by Falsification of Medical Products and Similar Crimes...

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