Newsroom European Pharmacopoeia
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...
Improved CombiStats online application now available
The CombiStats online application is available as of 4 July 2024, with an improved interface, a new licensing system and a dedicated user workspace. Users are invited to start using the online application, by creating an account and following the registration steps. The contact person who placed...
Pharmeuropa 36.3 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 36.3 is 30 September 2024. Users and interested parties are welcome to comment on these drafts. It...
Outcome of the 179th session of the European Pharmacopoeia Commission, June 2024
The European Pharmacopoeia Commission (EPC) held its 179th session on 18 and 19 June 2024. A summary of its outcome is available in the infographic below. Highlights will be published shortly on our website and the full list of adopted texts will be made available on the Ph. Eur. Work Programme...
European Pharmacopoeia Supplement 11.6 now available
The European Pharmacopoeia (Ph. Eur.) Supplement 11.6 is now available and will be applicable in 39 European countries as of 1 January 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...
New general chapter on Extractable elements in plastic materials for pharmaceutical use (2.4.35) adopted
With the implementation of the ICH Q3D guideline on elemental impurities, the control of elemental impurities has undergone a shift in paradigm, moving away from pure substance-based testing towards a holistic control strategy at the medicinal product level. Parts of the Introduction and Scope of...
Pharmacopoeial Discussion Group achievements
The Pharmacopoeial Discussion Group (PDG) held its interim videoconference on 15 April 2024. The primary topic of the meeting was the lessons learned from the PDG expansion pilot programme that was launched in 2022 and ended in October 2023 with the inclusion of the Indian Pharmacopoeia...
Save the date – Get ready to join our webinar on 12 November 2024
BINACLE Assay for Tetanus Neurotoxin: Outcomes of Collaborative Study BSP136 The testing procedure in the European Pharmacopoeia (Ph. Eur.) for demonstrating the absence of tetanus toxin from toxoids used in the manufacture of both human and veterinary vaccines currently consists of an in vivo...
Save the date! “EDQM workshop: exploring a certification system for the validation of rapid microbiological methods”
The European Directorate for the Quality of Medicines & HealthCare (EDQM) is pleased to announce that it is organising a workshop to explore a certification system for the validation of rapid microbiological methods (RMMs), that will be of interest to suppliers and users of RMM equipment....
European Pharmacopoeia Supplements 11.6 to 11.8 – 2025 subscriptions now open!
The 2025 subscriptions to the European Pharmacopoeia (Ph. Eur.), including the Supplements 11.6 to 11.8, are now available for purchase in the WebStore of the European Directorate for the Quality of Medicines & HealthCare (EDQM). Two subscription formats are available. Both include access to all...
Public consultation on new general texts on mRNA vaccines in Pharmeuropa 36.2
The European Pharmacopoeia (Ph. Eur.) is seeking stakeholder feedback on a series of three new general texts on mRNA vaccines, published in this quarter’s issue of Pharmeuropa 36.2 for comment. The mRNA vaccine field has developed rapidly in the past few years and continues to evolve into an...
Public consultation on new general chapter on High-throughput sequencing for the detection of viral extraneous agents in Pharmeuropa 36.2
The European Pharmacopoeia (Ph. Eur.) is seeking stakeholder feedback on its new general chapter, HTS for the detection of viral extraneous agents (2.6.41), published in this quarter’s issue of Pharmeuropa (36.2) for comment. High-Throughput Sequencing (HTS, also known as Next-Generation...
Don’t miss your chance to comment: HPTLC fingerprinting in two monographs on homoeopathic preparations
The first two monographs, Calendula for homoeopathic preparations (2492) and Chamomilla for homoeopathic preparations (2493), resulting from the pilot study on the use of semi-quantitative high-performance thin-layer chromatography (HPTLC) fingerprinting for homoeopathic preparations containing...