Press Release - Update on EDQM’s actions following detection of impurity in valsartan - August 2018
The EDQM is continuing the investigations and actions which started in July 2018 to address the issue related to the detection of a nitrosamine (N-nitrosodimethylamine (NDMA)) in a source of active substance valsartan.
Press Release - EDQM’s actions to evaluate impact of impurity in active substance valsartan - 27 July 2018
The European Directorate for the Quality of Medicines & HealthCare (EDQM) is aware of a quality defect related to a n impurity in the active substance valsartan used in medicines to treat high blood pressure marketed in Europe.
Press Release - Outcome of the 161st Session of the European Pharmacopoeia Commission - June 2018
Outcome of the 161st Session of the European Pharmacopoeia Commission 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.
Press Release - new building will ensure continuity in pharmaceutical reference standards supply - June 2018
The first stone of the new secondary site of the Council of Europe’s European Directorate for the Quality of Medicines and HealthCare (EDQM) was laid today. The new site will be used to store its portfolio of over 3 000 pharmaceutical reference standards, as an addition to those already in stock at the main EDQM building in Strasbourg.
Press release 14 2018 - OMCLs discuss Brexit and updates to medicines’ testing methods at annual meeting - May 2018
The Annual Meeting of the Official Medicines Control Laboratories (OMCLs) took place on 14-18 May in Sarajevo (Bosnia and Herzegovina). It was attended by 230 participants from 38 countries, representing 65 official laboratories and including a representative of the OMCL Network, the Taiwan Food and Drug Administration, which just joined the Network as an associated member. Representatives from Canada, Israel, the Russian Federation and Singapore also attended the event, which was jointly organised by the EDQM and the Agency for Medicinal Products and Medical Devices of Bosnia and Herzegovina (ALMBiH).
Press Release - European and Indian Pharmacopoeias to cooperate further on provision of strong quality standards for medicines - May 2018
The EDQM/European Pharmacopoeia (Ph. Eur.) and the Indian Pharmacopoeia Commission (IPC) held a symposium on the quality control of medicines in the context of the pharmaceutical legislation and regulatory requirements that exist in Europe and India.
Press Release - Pharmacopoeial Discussion Group (PDG) holds first videoconference meeting - May 2018
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.
Press release - Committee on organ transplantation at Council of Europe warns against Global Kidney Exchange programmes - April 2018
The Council of Europe Committee on Organ Transplantation (CD-P-TO), with the support of the Council of Europe Committee on Bioethics (DH-BIO), has issued a recommendation to the Member States of the Council of Europe, as well as health authorities, hospitals and professionals not to engage in Global Kidney Exchange (GKE) programmes and hence not to consider the inclusion of “financially incompatible” donor-recipient pairs in any kidney exchange programme.
Press Release - Ph. Eur. - Live Biotherapeutic Products (LBPs): unprecedented quality requirements by the Ph. Eur. Commission - April 2018
At its 160th Session, the European Pharmacopoeia (Ph. Eur.) Commission achieved an important milestone in the setting of quality requirements for Live Biotherapeutic Products (LBPs) with the adoption of quality standards for LBPs for human use: a general monograph on Live biotherapeutic products for human use (3053), as well as two general chapters: Microbial examination of live biotherapeutic products (LBP): test for enumeration of microbial contaminants (2.6.36) and Microbiological examination of live biotherapeutic products: test for specified microorganism (2.6.38).
Press Release - Ph. Eur. - Infrared Absorption Spectrophotometry - April 2018
At its 160th session (March 2018) the Ph. Eur. Commission adopted a new version of one of its major general methods, which has undergone extensive revision. The chapter on Infrared Absorption Spectrophotometry (2.2.24) is one of the original cornerstones of pharmacopoeial testing, referenced in many general texts and more than 1200 individual monographs.