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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...
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...
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...
1 May 2024
Public holiday: EDQM offices closed on 1 May 2024
Due to a public holiday in France, the European Directorate for the Quality of Medicines & HealthCare (EDQM) will be closed on Wednesday 1 May 2024.
Normal business hours will resume on Thursday 2 May 2024.
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...
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The European Directorate for the Quality of Medicines & HealthCare is seeking comments from interested parties on a draft guidance document on the topic of “Traceability of Medicines in Hospital Settings”.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...
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...
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...
Scientific Assistant – Scientific Procurement
Do you wish to further develop your scientific skills in the procurement of chemical and biological substances?
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...
How to identify the manufacturing sites linked to CEP application (revised document)?
Please consult the revised policy document which has been updated to complete the identification of the manufacturing sites by the SPOR OMS coordinates. The use of these coordinates is mandatory, and companies should ensure that their organisation name and location address(es) given to the EDQM...
CEP holders invited to comment on draft monographs published in Pharmeuropa 36.2
Holders of Certificates of suitability to the monographs of the European Pharmacopoeia (CEPs) are requested to consult the list of substances for which draft revised monographs of the European Pharmacopoeia (Ph. Eur.) have been published in Pharmeuropa 36.2. The table below lists the substances...
Certification monthly report of activities: End of March 2024
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of March 2024 Certification Monthly Report For more information, access the Certification Database.
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...
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...
As a CEP applicant, you want to improve the quality of your dossier? The revised EDQM guideline “content of the dossier” and other key documents will be useful tools
The revised version of the EDQM guideline “Content of the dossier for chemical purity and microbiological quality of substances for pharmaceutical use” is now available and will be implemented as of 1st May 2024. This guideline and other key documents (QOS, top ten deficiencies), as well as the...
7 new Ph. Eur. reference standard and 17 replacement batches released in March 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...
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