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Certification of suitability (CEP) / Procedure of certification (general) | News | 21 September 2018 | Strasbourg, France
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available.
European network of OMCLs | News | 21 September 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 analytical principles.
Transplantation / Publications / Transplant Newsletter | News | 21 September 2018 | Strasbourg, France
The Newsletter Transplant summarises comprehensive data provided by national focal points designated by governments on donation and transplantation activities.
European Pharmacopoeia / General | News | 18 September 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 complete picture of their roadmap on the quality of excipients in China. The ChP illustrated the...
European network of OMCLs | News | 14 September 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 of Suitability to the monographs of the European Pharmacopoeia) and whose substances may present a...
Reference Standard | News | 07 September 2018 | Strasbourg, France
9 new Ph. Eur. Reference Standards (RS) were released in August 2018
Certification of suitability (CEP) / Procedure of certification (general) | News | 06 September 2018 | Strasbourg, France
The revised EDQM ‘Guideline on requirements for revision/renewal of Certificates of Suitability to the European Pharmacopoeia Monographs’ (PA/PH/CEP (04) 2 7R) will enter into force in January 2019.
Certification of suitability (CEP) | News | 28 August 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.
European Pharmacopoeia / Monograph | News | 10 August 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).
Transfusion / Projects | News | 08 August 2018 | Strasbourg, France
A symposium on ‘Plasma Supply Management’ will take place on 29-30 January 2019 in Strasbourg. This symposium will discuss the facts and scientific evidence surrounding the collection of plasma for fractionation and the elaboration of donor eligibility criteria to ensure donor protection.
Certification of suitability (CEP) / API | News | 27 July 2018 | Strasbourg, France
The 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.
Certification of suitability (CEP) / Procedure of certification (general) | News | 20 July 2018 | Strasbourg, France
Supplement 9.6 of the 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 2019, and to follow the instructions given in the document.
Certification of suitability (CEP) / Procedure of certification (general) | Guideline | 17 July 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.
European Pharmacopoeia / Monograph | News | 17 July 2018 | Strasbourg, France
Pharmeuropa contains draft pharmacopoeial texts for which the European Pharmacopoeia Commission is seeking comment. If you would like to receive e-mail alerts when an issue is complete, please register for Pharmeuropa online. Pharmeuropa issue 30.3 is now complete. Deadline for comments: 30 September 2018.
Products and Services | News | 17 July 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 pharmaceutical use and require evaluation during the risk assessment across all potential sources of...