Newsroom
Ph. Eur. publication schedule evolves to better meet users’ needs
The European Directorate for the Quality of Medicines & HealthCare (EDQM) is pleased to announce a major evolution of the European Pharmacopoeia (Ph. Eur.) publication schedule, starting with Issue 13.1. Together with its transition to a fully online version, the Ph. Eur. is adopting a new...
Outcome of the 183rd session of the European Pharmacopoeia Commission
The European Pharmacopoeia Commission (EPC) held its 183rd session on 18-19 November 2025. The EPC adopted 81 texts at this session, to be published in European Pharmacopoeia (Ph. Eur.) Issue 13.1 (April 2026) and be effective as of 1 January 2027. These 81 texts included 7 new monographs and 2...
European Pharmacopoeia publishes first individual monoclonal antibody medicinal product monograph
The European Pharmacopoeia (Ph. Eur.) has continued to build upon its work in the field of therapeutic monoclonal antibodies with the publication of its first monoclonal antibody (mAb) medicinal product monograph, for the IgG1-antibody based TNF-alpha antagonist, Golimumab injection (3187). The...
Pharmacopoeial discussion group achievements
The Pharmacopoeial Discussion Group (PDG) held its annual meeting from September 30 to October 1, 2025 in Tokyo, Japan. The group welcomed the Korean Pharmacopoeia (KP) as a candidate participant in this meeting. In this capacity, KP joined the discussions alongside the PDG members－the European...
Join the EDQM as an Innovation Project Officer (AI)!
Who we are: At the European Directorate for the Quality of Medicines & Healthcare (EDQM), our vision is clear: “Together for better health, for all”. We contribute to public health protection by engaging with an international community of experts and stakeholders. Now is your opportunity to join...
Two new EDQM publications on herbal food supplements for healthcare professionals and consumers
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published two documents, a guide and a leaflet, on herbal food supplements, one targeting healthcare professionals, the other consumers. The electronic versions of these documents can be downloaded from FreePub, the...
EDQM reference standards monthly newsletter – November 2025
4 new European Pharmacopoeia reference standard and 12 replacement batches released in November 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...
EDQM releases draft revised “Guideline on requirements for revision/renewal of certificates of suitability to the European Pharmacopoeia monographs” – for public consultation
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has revised the “Guideline on requirements for revision and renewal of certificates of suitability to the European Pharmacopoeia monographs” (PA/PH/CEP (04) 02) to align it with the requirements of the applicable revised EU...
EDQM contributes to article on NGS for adventitious virus detection published in Biologicals
The European Directorate for the Quality of Medicines & HealthCare (EDQM) continues its collaboration on next-generation sequencing (NGS, also called high-throughput sequencing, or HTS), contributing directly to the 4th Conference on NGS for Adventitious Virus Detection held on 4 and 5 December...
Key outcomes of 2025 international EDQM Blood Conference published
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has collaborated with scientific committee members on an article published in Blood Transfusion, entitled “Innovation in Blood Establishment Processes, Strasbourg, 2025: a Conference Report”, that highlights the key...
Certified for Success: highlights from the CEP conference
The EDQM conference “Certified for success: using the CEP Procedure to elevate quality and drive trust”, held on 23 and 24 September 2025, brought together over 125 participants (representing 25 countries) from across the pharmaceutical and chemical industries, regulatory agencies and academia to...
2025 EDQM virtual training programme
Do you work in drug development, R&D, pharmaceutical quality assurance and quality control or in regulatory affairs? Join the EDQM virtual training programme comprising nine independent modules on the Ph. Eur., reference standards and the CEP Procedure designed to enhance your expertise. The...
Certification monthly report of activities: End of October 2025
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of October 2025 Certification Monthly Report For more information, access the Certification Database.
Certification monthly report of activities: End of October 2025 Duplicate 1
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of October 2025 Certification Monthly Report For more information, access the Certification Database.
EDQM end-of-year closure: order and shipment deadlines
Order and shipment deadlines have been established for publications and reference standards, taking into account the closure of the European Directorate for the Quality of Medicines & HealthCare (EDQM) offices from Tuesday 23 December 2025 (12 noon CET) to Monday 5 January 2026 (8 a.m. CET). The...
Newsletter Transplant 2025 – Transparency, ethical governance and equitable access
A new edition of Newsletter Transplant has just been published, presenting data on organ donation and transplantation activities worldwide in 2024. This year’s report covers a record 92 countries. Organ transplantation activities increased globally by 2% in 2024, driven primarily by a rise in...
EDQM clarifies the stepwise process to getting a CEP or having a change approved
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published a new document called “Stepwise process to get a CEP or having a change approved”. This document is intended to clarify, for all types of application, the process and steps for obtaining a certificate of...
Pyrogen testing 2.0: Ethical, Evolving and Eco-friendly – Registration open
Registration is now open for our upcoming joint EDQM-EPAA symposium titled “Pyrogen testing 2.0: Ethical, Evolving and Eco-friendly”. In February 2023, the EDQM and the European Partnership for Alternative Approaches to Animal Testing (EPAA) hosted a landmark conference to present the European...
EDQM reference standards monthly newsletter – October 2025
2 new European Pharmacopoeia reference standard and 10 replacement batches released in October 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...
Publication of the French translation of the EDQM Blood Guide – A milestone for global co-operation in healthcare
We are delighted to announce the publication of the French translation of the 22nd edition of the Guide to the preparation, use and quality assurance of blood components (Blood Guide), a key reference document in the field of blood transfusion and quality management. This translation marks a...
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