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 Commission at its 160th Session in March 2018 – will not be published in Ph.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).
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 / 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.
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.
European Pharmacopoeia / Monograph | News | 05 June 2018 | Strasbourg, France
The monograph for Water, highly purified (HPW) will be suppressed on 1 April 2019 from the Ph. Eur.
European Pharmacopoeia / General text/chapter | News | 23 May 2018 | Strasbourg, France
Following up on issues that were reported with the revised limit test on Arsenic (method A, 2.4.2) published in Supplement 9.4., the Ph. Eur. Commission decided to revert back to the previous version of the chapter 2.4.2., until further notice.
European Pharmacopoeia / Pharmacopoeial discussion group (PDG) | News | 15 May 2018 | Strasbourg, France
The Pharmacopoeial Discussion Group (PDG), consisting of representatives from the European Pharmacopoeia (Ph.Eur.), Japanese Pharmacopoeia (JP), the United States Pharmacopoeia (USP) and the WHO (International Pharmacopoeia) as observer, held its first interim videoconference on Wednesday 11 April 2018.
European Pharmacopoeia | News | 15 May 2018 | Strasbourg, France
The EDQM/European Pharmacopoeia (Ph. Eur.) and the Indian Pharmacopoeia Commission (IPC) held a symposium in Mumbai to discuss the quality control of medicines in the context of the pharmaceutical legislation and regulatory requirements that exist in Europe and India.
European Pharmacopoeia / 3Rs | News | 11 May 2018 | Strasbourg, France
An article summarising the activities of the European Pharmacopoeia Commission in the field of the 3Rs within the last decade has just been published. In addition to the progress in the Ph. Eur. texts, the article also describes tools utilised in the implementation of the 3R principles as well as the challenges encountered and future perspectives.