Newsroom European Pharmacopoeia
New FAQ on EDQM HelpDesk: system suitability test in assay chromatographic procedures
Following queries received from users through the EDQM HelpDesk, a new FAQ on the system suitability test (selectivity) in assays by chromatographic procedures has been added to the existing series of FAQs dealing with the European Pharmacopoeia & International harmonisation. This addition is...
European Pharmacopoeia Supplement 11.8 now available
The European Pharmacopoeia (Ph. Eur.) Supplement 11.8 is now available and will be applicable in 39 European countries as of 1 July 2025. This volume is included in the 2025 subscription (11.6, 11.7 and 11.8) to the 11th Edition of the Ph. Eur. Subscriptions for print and/or electronic versions...
European Drug Shortages Formulary project: approval of framework and procedure documents
The European Drug Shortages Formulary (EDSForm) project plays a key role in the EDQM’s efforts to address medicine shortages in Europe. With work led by the European Drug Shortages Formulary Working Party (EDSForm WP), the aim of the project is to provide guidance for hospital and community...
Outcome of the 180th session of the European Pharmacopoeia Commission, November 2024
The European Pharmacopoeia Commission (EPC) held its 180th session on 19 and 20 November 2024. A summary of its outcome is available in the infographic below. Highlights will be published shortly on the website of the European Directorate for Quality of Medicines & HealthCare (EDQM) and the full...
General chapter Elemental Impurities (G-07) harmonised by the Pharmacopoeial Discussion Group
The new harmonised general chapter “Elemental Impurities (G-07)” was signed-off by the Pharmacopoeial Discussion Group (PDG) on 19 June 2024. The PDG brings together the European Pharmacopoeia (Ph. Eur.), Indian Pharmacopoeia Commission (IPC), Japanese Pharmacopoeia (JP) and the United States...
EDQM On Air – Discover the vast international network working to protect your public health
The European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe works with many national and international stakeholders for the protection of public health. Tune in now to find out more about their collaboration and the real-life outcomes of their work by...
A new era for the European Pharmacopoeia – Online-only format from June 2025
The European Directorate for the Quality of Medicines & HealthCare (EDQM) will launch the online-only European Pharmacopoeia (Ph. Eur.) in June 2025, bringing legally binding European pharmacopoeial standards to subscribers in a modern and easier-to-use format. The discontinuation of the printed...
Pharmeuropa 36.4 just released
All new European Pharmacopoeia (Ph. Eur.) texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments on Pharmeuropa 36.4 is 31 December 2024. Users and interested parties are welcome to comment on these drafts. It should...
Webinar – Advancements in gene therapy: the European Pharmacopoeia’s new approach
The European Directorate for the Quality of Medicines & HealthCare (EDQM) will hold a free webinar entitled “Advancements in gene therapy: the European Pharmacopoeia’s new approach” on 3 December 2024, from 14:00 to 16:00 (CET, Paris, France). REGISTER NOW In response to the recent approval of...
European Pharmacopoeia Supplement 11.7 now available
The European Pharmacopoeia (Ph. Eur.) Supplement 11.7 is now available and will be applicable in 39 European countries as of 1 April 2025. This volume is included in the 2025 subscription (11.6, 11.7 and 11.8) to the 11th Edition of the Ph. Eur. Subscriptions for print and/or electronic versions...
PDG announces global membership initiative
The Pharmacopoeial Discussion Group (PDG) is excited to announce the launch of the next phase of its global expansion initiative aimed at increasing convergence of harmonised pharmacopoeial standards. This initiative will be the start of a process over the next couple of years to welcome...
Update on BSP study on the evaluation of a replacement method for the potency control of whole cell pertussis vaccines
The Biological Standardisation Programme (BSP) wishes to inform the scientific community that the project coded BSP104 has been brought to a close. The project aimed at evaluating a replacement method for the in vivo challenge test for the potency control of whole-cell pertussis vaccines...
Article on joint WHO/EDQM establishment study for Prekallikrein activator in albumin reference standards now online
The outcome of the successful study to establish the European Pharmacopoeia (Ph. Eur.) Biological Reference Preparation (BRP) for Prekallikrein activator in albumin batch 7 has been published in the scientific journal Pharmeuropa Bio & Scientific Notes. The study (BSP153) was organised jointly by...
New monographs on an anti-interleukin monoclonal antibody released for public consultation
The European Pharmacopoeia (Ph. Eur.) has published two new draft monographs, Ustekinumab concentrated solution (3165) and Ustekinumab injection (3188), for public comment in this quarter’s issue of Pharmeuropa (36.3). Following the adoption and publication of the monographs for Etanercept...
Ph. Eur. seeks feedback on the use of plastic additive 18
Plastic additive 18 (P-EPQ, for more details see appendix ) is a phenolic antioxidant that may be used as a stabiliser in the processing of plastic materials. It consists of seven components, all of which contribute to the efficiency of the additive, but is a product-by-process (reaction product)...
Call for experts – Join the Bovine Serum Working Party!
Bovine serum is widely used in the manufacture of human and veterinary medicinal products, for example as a supplement in cell culture media for the production of vaccines (both human and veterinary) and advanced therapy medicinal products (ATMPs). The European Pharmacopoeia (Ph. Eur.) monograph...
Making a significant difference – 2023 EDQM annual report published in new engaging digital format
The European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe has published its 2023 annual report. For the first time, the report is completely digital, with a new, intuitive design and interactive features, facilitating your discovery journey and making it...
Shortage of amoxicillin paediatric products: expert opinion of the European Drug Shortages Formulary Working Party
Amoxicillin is an aminopenicillin used to treat a number of infections. In recent years (particularly during the winter months), several member states have reported major difficulties in procuring amoxicillin-containing products, with paediatric forms of the antibiotic especially affected. In...
Ph. Eur. bids adieu to rabbit pyrogen test in its monographs
Pyrogen detection is essential for ensuring the safety of parenteral medicines. For decades, the rabbit pyrogen test (RPT) has been the traditional method. The RPT involves measuring the rise in body temperature in rabbits following intravenous injection of the substance to be examined. Despite...
Three revised texts related to pharmaceutical waters published in Pharmeuropa 36.3
The European Pharmacopoeia (Ph. Eur.) is seeking stakeholder feedback on the following revised texts, published in this quarter’s issue of Pharmeuropa (36.3) for comment: Water for injections (0169) Purified water (0008) Total organic carbon in water for pharmaceutical use (2.2.44) The main focus...