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...
Products and Services | 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 Commission at its 160th Session in March 2018 – will not be published in Ph.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) / 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.
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...
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.
Anti-Counterfeiting activities / Counterfeit/illegal medical products | News | 16 July 2018 | Strasbourg, France
This project will favour better interaction between the analytical and enforcement actors involved in the fight against falsified medicines and medical devices.
Products and Services | News | 13 July 2018 | Strasbourg, France
The catalogue of the European Pharmacopoeia (Ph. Eur.) offers a portfolio of more than 2 800 reference standards. It is updated on a daily basis and gives access to all the Ph. Eur. reference standards and to Batch Validity Statement (BVS), Safety Data Sheets, leaflets.
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.
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.
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.