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.
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) | 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 Commission at its 160th Session in March 2018 – will not be published in Ph.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).
Certification of suitability (CEP) / Procedure of certification (general) | News | 08 August 2018 | Strasbourg, France
Users of CEPs are invited to provide comments on draft monographs published in Pharmeuropa 30.3 before 30 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.
European Pharmacopoeia / Monograph | News | 10 July 2018 | Strasbourg, France
The new monograph on Sulfobutylbetadex sodium (2804) was published in Supplement 9.6 of the European Pharmacopoeia.
European Pharmacopoeia / Announcements | News | 10 July 2018 | Strasbourg, France
The 9.6 supplement of European Pharmacopoeia is now available and will be applicable in 38 European countries as from 01 January 2019.
EDQM / All activities | Report | 02 July 2018 | Strasbourg, France
The EDQM has released its 2017 Annual Report providing an overview of its accomplishments. Among the major highlights for the past year, the European Pharmacopoeia (Ph. Eur.) Commission kept on ensuring that the monographs and texts of the Ph.Eur. stay abreast of scientific and technological progress and achieved considerable progress in the field of biotherapeutic products. For example, the...
European Pharmacopoeia / Ph. Eur. Commission | News | 29 June 2018 | Strasbourg, France
At its 161st Session, which took place in Strasbourg on 19-20 June 2018, the European Pharmacopoeia (Ph. Eur.) Commission adopted 10 new monographs, 1 new chapter, 92 revised monographs and 7 revised chapters.
European Pharmacopoeia / Biologicals | News | 29 June 2018 | Strasbourg, France
The new biotherapeutics section on the EDQM website summarises Ph. Eur. Commission activities and achievements in this field. In addition to clarification of the role of Ph. Eur. monographs in the biosimilars regulatory pathway, it describes the recently concluded P4-BIO pilot phase and the ongoing pilot phase on monoclonal antibodies (“MAB pilot phase”), explaining the strategy followed by the...
European Pharmacopoeia / Announcements | News | 20 June 2018 | Strasbourg, France
To celebrate the publication of the 10th Edition of the European Pharmacopoeia (Ph. Eur.) and the 25th anniversary of the establishment of the European Network of Official Medicines Control Laboratories (OMCLs) and the Certification of suitability to the monographs of the European Pharmacopoeia procedure, the EDQM is organising an international conference in Strasbourg (France) on 19-20 June 2019.
EDQM | News | 12 June 2018 | Metz, France
The first stone of a new secondary site for the Council of Europe’s European Directorate for the Quality of Medicines and HealthCare (EDQM) has been laid. The new site will be used to store the EDQM’s portfolio of over 3 000 pharmaceutical reference standards, as an addition to those already in stock at the main building in Strasbourg.