Newsroom European Pharmacopoeia
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...
Celebrating 60 years of excellence – Explore our conference programme
Celebrating 60 years of excellence and dedication to ensuring the availability of and access to good quality and safe medicines and health products, the EDQM is gearing up for a major event. Join us for a high-level gathering that pays tribute to our rich history while sparking discussions on...
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...
EDQM Open Day – Join us for an afternoon full of discovery
The European Directorate for the Quality of Medicines & HealthCare (EDQM) will open its doors to the public on Sunday 16 June 2024 from 13:30 to 18:00. Full information is available on the dedicated EDQM Open Day web page. Join us for a fun-packed afternoon to discover how the EDQM contributes to...
Public consultation on a new general chapter on cell-based preparations for human use in Pharmeuropa 36.2
In response to the need for a text covering the quality of cell-based preparations in the rapidly evolving field of advanced therapy medicinal products, the European Pharmacopoeia Commission is proposing a new general chapter, Cell-based preparations for human use (5.32), to its stakeholders. The...
New European Pharmacopoeia Commission approach to gene therapy
General chapter 5.14. Gene transfer medicinal products for human use was first published in European Pharmacopoeia (Ph. Eur.) Supplement 5.6 in 2006, when there were no approved gene therapy medicinal products (GTMPs) on the European market. Several GTMPs have since been approved and an...
Shortage of aprepitant, powder for oral suspension – Expert opinion of the EDSForm Working Party
Aprepitant is a NK1 receptor antagonist that is mainly used in the prevention of chemotherapy-induced or postoperative nausea and vomiting. The only licensed medicinal product containing aprepitant that is appropriate for paediatric patients – a powder for oral suspension (Emend 125 mg powder for...
Critical medicine shortages - immediate workflow and trial phase with two ongoing shortages
The task of the European Drug Shortages Formulary Working Party (EDSForm WP), created at the end of November 2023, is to define both short-term and long-term actions aimed at mitigating the negative impact of medicine shortages on public health. Short-term actions involve compiling technical...
Deadline extended to 30 April: survey on strategy for Ph. Eur. quality standards for monoclonal antibodies
In 2014, the European Pharmacopoeia Commission (EPC) launched a pilot phase on setting public standards for therapeutic monoclonal antibodies (mAbs) (“MAB pilot phase”). This pilot phase was intended to explore the feasibility of establishing individual monographs for multi-source mAbs, as well...
European Pharmacopoeia to put an end to all animal tests for histamine and depressor substances
At its 177th session in November 2023, the European Pharmacopoeia Commission (EPC) decided to engage on a path that should ultimately lead to the deletion of the general chapters on Histamine (2.6.10) and Depressor substances (2.6.11) from the European Pharmacopoeia (Ph. Eur.). Both chapters...
New general chapter on Phage therapy medicinal products (5.31) adopted and pre-published on the EDQM website
Rising levels of antimicrobial resistance in recent years, identified as one of the leading threats to global public health and development, have prompted renewed interest in the use of phage therapy for the treatment of bacterial infections. This led the European Pharmacopoeia Commission (EPC)...
JP and Ph. Eur. launch a bilateral prospective harmonisation project for active substance and medicinal product monographs
The Japanese Pharmacopoeia (JP) and the European Pharmacopoeia (Ph. Eur.) are pleased to announce the launch of a bilateral prospective harmonisation project targeting pharmacopoeial standards for active substances and medicinal products. Pharmacopeial harmonisation serves to further reduce the...
Pharmeuropa 36.2 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 36.2 is 30 June 2024. Users and interested parties are welcome to comment on these drafts. It should be...
Survey on strategy for Ph. Eur. quality standards for monoclonal antibodies
In 2014, the European Pharmacopoeia Commission (EPC) launched a pilot phase on setting public standards for therapeutic monoclonal antibodies (mAbs) (“MAB pilot phase”). This pilot phase was intended to explore the feasibility of establishing individual monographs for multi-source mAbs, as well...