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European Pharmacopoeia Issue 12.3 now available
The European Pharmacopoeia (Ph. Eur.) Issue 12.3 is now available and will be applicable in 39 European countries as of 1 July 2026. This issue is available on the Ph. Eur. Online platform for all holders of a valid 365-day licence, along with all texts currently in force and texts published...
CD-P-TO reinforces valuable participation of professional societies by welcoming ISHLT as observer
The European Committee on Organ, Tissues and Cells (CD-P-TO) granted observer status to the International Society for Heart & Lung Transplantation (ISHLT) at its last plenary meeting in October by unanimous decision. This professional society can now participate in the activities of the CD-P-TO,...
CEP holders invited to comment on draft monographs published in Pharmeuropa 38.1
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 38.1. The table below lists the substances...
EDQM reference standards monthly newsletter – December 2025
5 new European Pharmacopoeia reference standards and 16 replacement batches released in December 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...
Pharmeuropa 38.1 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 38.1 is 31 March 2026. Users and interested parties are welcome to comment on these drafts. It should be...
2025 – A year of collaboration, new beginnings and long-standing commitments
In a year of rapid transformation, significant challenges and promising new opportunities, the European Directorate for the Quality of Medicines & HealthCare (EDQM) worked hand in hand with its stakeholders to safeguard public health and uphold trust in public health protection. Collaboration and...
A major step towards animal-free testing for the test for bacterial endotoxins
The European Pharmacopoeia (Ph. Eur.) is moving into a new era of innovation and sustainability. Starting 1 January 2026, the rabbit pyrogen test (general chapter 2.6.8. Pyrogens) will disappear from Ph. Eur. texts, ending decades of reliance on animal-based methods. This change reflects a clear...
EDQM publishes booklet on add-ons in medically assisted reproduction treatments
The European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe has published a new booklet entitled “Add-ons in medically assisted reproduction treatments – A guide for those seeking fertility care”. This comprehensive booklet, available for free download, aims...
Certification monthly report of activities: End of November 2025
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of November 2025 Certification Monthly Report For more information, access the Certification Database.
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...
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...
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