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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....
EPC successfully concludes pilot phase on monoclonal antibodies, setting the stage for future standardisation in this field
The European Pharmacopoeia Commission (EPC) formally endorsed the conclusion of the pilot phase on monoclonal antibodies (mAbs) during its 182nd session, marking a major milestone in the development of public standards for these complex biotherapeutics. Launched in 2014, the pilot phase aimed to...
Pharmacopeial Discussion Group announces outcome of 2025 expansion round
The Pharmacopeial Discussion Group (PDG) is pleased to share the outcome of its latest expansion round. The initial expansion phase launched in 2022 led, after a successful pilot phase, to the inclusion of the Indian Pharmacopoeia Commission as the first new member of the PDG in 2023. Building on...
Egypt joins EDQM’s OMCL Network as an associated member
The BIO INN Laboratories of the Egyptian Drug Authority (EDA) have joined the General European OMCL Network (GEON), co-ordinated by the European Directorate for the Quality of Medicines & HealthCare (EDQM), as an associated member. After Morocco, it is the second African official medicines...
Certification monthly report of activities: End of June 2025
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of June 2025 Certification Monthly Report For more information, access the Certification Database.
CEP holders invited to comment on draft monographs published in Pharmeuropa 37.3
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 37.3. The table below lists the substances...
Tips to improve the quality of your dossier and get a CEP faster
As an applicant using the Certification of suitability to the monographs of the European Pharmacopoeia (CEP) procedure, you play a central role in ensuring the smooth processing of your request. One of the best ways to accelerate the process is by improving the quality of your submission....
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