European Pharmacopoeia Supplements 11.6 to 11.8 – 2025 subscriptions now open!

EDQM 17/05/2024 Strasbourg, France

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...

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Celebrating 60 years of excellence – Explore our conference programme

EDQM 25/04/2024 Strasbourg, France

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...

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Public consultation on new general texts on mRNA vaccines in Pharmeuropa 36.2

EDQM 14/05/2024 Strasbourg, France

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...

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Public consultation on new general chapter on High-throughput sequencing for the detection of viral extraneous agents in Pharmeuropa 36.2

EDQM 07/05/2024 Strasbourg, France

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...

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Don’t miss your chance to comment: HPTLC fingerprinting in two monographs on homoeopathic preparations

EDQM 29/04/2024 Strasbourg, France

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...

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EDQM Open Day – Join us for an afternoon full of discovery

EDQM 02/05/2024 Strasbourg, France

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...

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Public consultation on a new general chapter on cell-based preparations for human use in Pharmeuropa 36.2

EDQM 29/04/2024 Strasbourg, France

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...

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New European Pharmacopoeia Commission approach to gene therapy

EDQM 29/04/2024 Strasbourg, France

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...

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Shortage of aprepitant, powder for oral suspension – Expert opinion of the EDSForm Working Party

EDQM 23/04/2024 Strasbourg, France

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...

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Critical medicine shortages - immediate workflow and trial phase with two ongoing shortages

EDQM 19/04/2024 Strasbourg, France

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...

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Deadline extended to 30 April: survey on strategy for Ph. Eur. quality standards for monoclonal antibodies

EDQM 12/04/2024 Strasbourg, France

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...

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European Pharmacopoeia to put an end to all animal tests for histamine and depressor substances

EDQM 10/04/2024 Strasbourg, France

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...

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New general chapter on Phage therapy medicinal products (5.31) adopted and pre-published on the EDQM website

EDQM 10/04/2024 Strasbourg, France

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)...

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JP and Ph. Eur. launch a bilateral prospective harmonisation project for active substance and medicinal product monographs

EDQM 09/04/2024 Strasbourg, France

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...

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Pharmeuropa 36.2 just released

EDQM 04/04/2024 Strasbourg, France

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...

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Survey on strategy for Ph. Eur. quality standards for monoclonal antibodies

EDQM 06/03/2024 Strasbourg, France

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...

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EDQM’s ISO 9001:2015 certification maintained

EDQM 08/02/2024 Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare’s (EDQM) ISO 9001:2015 certificate has been maintained following the second surveillance audit of its quality management system on 28 and 29 November 2023 by the official French standardisation body Association française de...

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Ph. Eur. progress in the field of homoeopathic manufacturing methods

EDQM 24/01/2024 Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare (EDQM) is proud to highlight the remarkable progress made in 2023 on European Pharmacopoeia (Ph. Eur.) texts on homoeopathic manufacturing methods, with the recent publication (January 2024) of three revised general monographs in...

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New strategy for N-nitrosamine impurities in Ph. Eur. monographs

EDQM 22/01/2024 Strasbourg, France

At its 177th session in November 2023, the European Pharmacopoeia Commission (EPC) approved the strategy for N-nitrosamine impurities in individual monographs. Regarding active substances The EPC agreed to delete the Production section covering N-nitrosamine impurities from existing individual...

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