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EDQM releases new report highlighting key trends in blood collection, supply and use in Europe
The European Directorate for the Quality of Medicines & Healthcare (EDQM) has published the latest activity report of the European Committee on Blood Transfusion (CD-P-TS) on the collection, supply and use of blood and blood components across Council of Europe member states for the years 2020 to...
Public holiday: EDQM offices closed on 15 August 2025
Due to public holidays in France, the European Directorate for the Quality of Medicines & HealthCare (EDQM) will be closed on Friday, 15 August 2025.
Management Support Assistant – Customs
We are looking for a highly organised and motivated colleague with solid experience in customs procedures...
Certification monthly report of activities: End of July 2025
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of July 2025 Certification Monthly Report For more information, access the Certification Database.
EDQM reference standards monthly newsletter – July 2025
6 new European Pharmacopoeia reference standard and 19 replacement batches released in July 2025 The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just published its monthly newsletter on the situation of European Pharmacopoeia reference standards. It includes...
Technical recommendation of the EDSForm WP: clarithromycin, paediatric products
Clarithromycin is a macrolide antibiotic widely used to treat a number of infections. Several member states have reported major difficulties in procuring clarithromycin-containing products, with paediatric forms (e.g. granules for oral suspension) especially affected. In line with the approved...
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Public consultation on a new monograph on Adalimumab concentrated solution in Pharmeuropa 37.3
The European Pharmacopoeia (Ph. Eur.) has published a new draft monograph, Adalimumab concentrated solution (3147), for public comment in this quarter’s issue of Pharmeuropa (37.3). Adalimumab is a widely used therapeutic human IgG1 kappa monoclonal antibody. It targets tumour necrosis factor...
Implementation of the 12th Edition of the European Pharmacopoeia – Notification for CEP holders
The 12th Edition of the European Pharmacopoeia (Ph. Eur.) is now available. Holders of Certificates of suitability to the monographs of the Ph. Eur. (CEPs) are invited to update their applications according to the revised monographs that will be implemented on 1 January 2026, and to follow the...
Lifting of restriction on Immunoglobulin (anti-A, anti-B antibodies test Negative control) BRP (cat. # Y0001689)
We are pleased to inform users that, following the official adoption of the replacement batch (batch 2) of the Immunoglobulin (anti-A, anti-B antibodies test Negative control) BRP (cat. # Y0001689), the distribution quota is being lifted. Batch 2 of this BRP will be distributed upon depletion of...
SAVE THE DATE! Joint EDQM-EPAA Symposium: “Pyrogen testing 2.0: Ethical, Evolving and Eco-friendly - Implementing safe, rapid, state-of-the-art and sustainable non-animal approaches worldwide”, 25-26 February 2026
The European Directorate for the Quality of Medicines & HealthCare (EDQM) is pleased to announce a symposium co-organised with the European Partnership for Alternative Approaches to Animal Testing (EPAA) entitled “ In February 2023, the EDQM and EPAA hosted a landmark conference to present the...
2024 EDQM annual report showcases our unwavering dedication to improving public health
The European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe has published its 2024 annual report. Once again, the report attests to our strong commitment to making better healthcare accessible for all and provides a comprehensive overview of the challenges...
EPC adopts three revised texts related to pharmaceutical waters – a major step towards global quality standards for sterilised water for injections
The European Pharmacopoeia Commission (EPC) adopted three revised texts related to pharmaceutical waters during its 182nd session in June 2025. This constitutes a significant step forward in converging quality standards for the most widely used excipients in the pharmaceutical industry. The...
Public consultation on a new general chapter 2.6.42. Test for procoagulant activity in immunoglobulin preparations in Pharmeuropa 37.3
The European Pharmacopoeia (Ph. Eur.) has published a draft of a new general chapter, 2.6.42. Test for procoagulant activity in immunoglobulin preparations, for public consultation in the current issue of Pharmeuropa (37.3). Stakeholders are invited to submit their comments by the end of...
Public consultation on a new general chapter 2.5.46. Phenolic antioxidants in plastic materials in Pharmeuropa 37.3
After several years of dedicated work by the experts of Group 16 (Plastic materials, plastic containers and closures), a new HPLC-UV analytical procedure has been developed to test for phenolic antioxidants in plastic materials and is described in the new general chapter 2.5.46. Phenolic...
Gradual rollout of a new primary label for European Pharmacopoeia reference standards
We would like to inform you that the EDQM will gradually introduce a new primary label for European Pharmacopoeia reference standards. This introduction will take place in several stages and will affect new reference standards (batch 1) placed on the market from the end of July 2025 onwards. It...
Ph. Eur. publishes revised general chapter 3.2.1. Glass containers for pharmaceutical use in Pharmeuropa 37.3
Thanks to the efforts and dedication of the experts of the Glass (GLS) Working Party, general chapter 3.2.1 has undergone its first significant revision since 2019, when it was published in European Pharmacopoeia (Ph. Eur.) Supplement 9.6. The primary aim of this revision is to clarify the...
Ph. Eur. NANO Working Party reaches significant milestone publication of its first monograph, Iron Sucrose concentrated solution, in Pharmeuropa
The European Pharmacopoeia (Ph. Eur.) Nanomedicines Working Party (NANO WP) has published its first monograph, Iron Sucrose concentrated solution (2753), for public consultation. This is a major step forward for the group established in 2023 after the European Pharmacopoeia Commission agreed to...
European Paediatric Formulary: Lorazepam 1 mg/mL oral solution monograph in public consultation
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just released Issue 11 of Pharmeuropa PaedForm, containing the 12th monograph of the PaedF Working Party, Lorazepam 1 mg/mL oral solution, for public consultation. The deadline for comments is 30 September 2025....
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