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Draft guideline on ‘Content of the dossier for sterile substances’ released for public consultation
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has drafted a guideline ‘Content of the dossier for sterile substances’ (PA/PH/CEP (23) 54). The draft document is now available for public consultation in the consultation space. The consultation deadline for this document...
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...
20 May 2024
Public holiday: EDQM offices closed on 20 May 2024
Due to a public holiday in France, the European Directorate for the Quality of Medicines & HealthCare (EDQM) will be closed on Monday 20 May 2024.
Normal business hours will resume on Tuesday 21 May 2024.
Cosmetics – Joint meeting of OCCL Network and CD-P-COS
The 13th meeting of the Network of Official Cosmetics Control Laboratories (OCCLs) was held in Strasbourg on 19 and 20 March 2024. This joint session brought together network members and experts from the European Committee for Cosmetics and Consumer Health (CD-P-COS). Participants from 26...
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...
Specialist - Nuclear magnetic resonance (NMR)
Grade: A1/2 Salary: from €5 536 to €7 074 per month (gross) Location: Strasbourg (France) Reference: Vacancy Notice n° e25/2024 Deadline for applications: 27/05/2024 Apply here Do you have practical/hands-on laboratory experience of nuclear magnetic...
Public consultation on Traceability of Medicines in Hospital Settings
The European Directorate for the Quality of Medicines & HealthCare is seeking comments from interested parties on a draft guidance document on the topic of “Traceability of Medicines in Hospital Settings”. The objective of this project is to provide regulatory authorities and stakeholders with a...
Certification monthly report of activities: End of April 2024
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of April 2023 Certification Monthly Report For more information, access the Certification Database.
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...
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...
5 new Ph. Eur. reference standard and 20 replacement batches released in April 2024
New Ph. Eur. reference standards and Replacement batches for Ph. Eur. reference standards Distribution quota Removal Future removal Change of sales units Information on change of amount per unit Information on change of price Change of EDQM storage/shipping conditions Information on International...
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...
EDQM call for tender – Elemental analysis (C, H, N, O, S)
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has launched a tender to select a service provider for elemental analysis (C, H, N, O, S) of various chemical compounds based on the needs of the organisation. Interested laboratories can submit their offers by 29 July 2024...
Publication of BSP study outcome on measuring procoagulant activity in human normal immunoglobulin available online
The outcome of a successful study on the determination of procoagulant activity in human normal immunoglobulin preparations for therapeutic use by FXIa chromogenic assay has recently been published in the EDQM online journal Pharmeuropa Bio & Scientific Notes. The article details the methods...
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...
Immunoglobulin (anti-A, anti-B antibodies test Negative control) BRP (cat. # Y0001689)
Further to the premature depletion of stocks of the Immunoglobulin (anti-A, anti-B antibodies test Negative control) BRP (cat. # Y0001689), we wish to inform users that the distribution quota has been revised. This BRP will be distributed to plasma-derived therapeutic product manufacturers and...
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