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Public consultation on revised general chapter 5.1.10. Guidelines for using the test for bacterial endotoxins in Pharmeuropa 38.2
The European Pharmacopoeia (Ph. Eur.) is seeking stakeholder feedback on the revised general chapter 5.1.10. Guidelines for using the test for bacterial endotoxins, published in this quarter’s issue of Pharmeuropa 38.2 for comment. General chapter 5.1.10 provides guidance for the use of the test...
European Pharmacopoeia Issue 13.1 now available
The European Pharmacopoeia (Ph. Eur.) Issue 13.1 is now available and will be applicable in 39 European countries as of 1 January 2027. 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...
Pharmeuropa 38.2 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 38.2 is 30 June 2026. Users and interested parties are welcome to comment on these drafts. It should be...
New milestone in the development of the certification concept for rapid microbiological methods
At its 184th Session in March 2026, the European Pharmacopoeia Commission (EPC) approved the creation of a new working party dedicated to the technical development of the certified review of microbiological methods per the European Pharmacopoeia, a novel concept that will also be known as “cMEP”....
Outcome of the 184th session of the European Pharmacopoeia Commission
The European Pharmacopoeia Commission (EPC) held its 184th session on 10-11 March 2026. The EPC adopted 50 European Pharmacopoeia (Ph. Eur.) texts that will be published in Issue 13.2 (July 2026) and will be effective as of 1 April 2027, and approved four new texts for the European Drug Shortages...
Council of Europe leading the way in animal welfare for over 40 years
Animal welfare has long been a major concern for the Council of Europe and the European Directorate for the Quality of Medicines & HealthCare (EDQM). The five conventions on the protection of animals developed within the Council of Europe were the first international legal instruments laying down...
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
A joint symposium was held on 25 and 26 February 2026 in Brussels, Belgium, co-organised by the European Directorate for the Quality of Medicines & HealthCare (EDQM) and the European Partnership for Alternative Approaches to Animal Testing (EPAA). The event, “Pyrogen testing 2.0: Ethical,...
SAVE THE DATE! EDQM Symposium: Microbiology on the Move, 13-15 October 2026
The European Directorate for the Quality of Medicines & HealthCare (EDQM) is delighted to announce its upcoming in-person symposium, Microbiology on the Move, taking place in Strasbourg (France) from 13-15 October 2026. Continuing its long-standing commitment to advancing microbiological quality...
Ph. Eur. 11th Edition platform now officially closed
The platform dedicated to the 11th Edition of the European Pharmacopoeia (Ph. Eur.) has been permanently taken offline. Access to the 12th Edition of the Ph. Eur. is now available exclusively via the new platform launched in June 2025. Licence renewal Need to renew your licence for the 12th...
European Pharmacopoeia Commission clarifies rFC integration and future innovation pathways
The European Pharmacopoeia Commission (EPC) has taken a significant step toward modern, animal-free testing by integrating recombinant Factor C (rFC) – a synthetic, validated solution – as one of the seven methods in general chapter 2.6.14. Bacterial endotoxins of the European Pharmacopoeia (Ph....
Congratulations to appointed Experts and Chairs
The European Pharmacopoeia Commission (EPC) is pleased to announce the appointment or reappointment of more than a thousand experts and chairs for the 2025–2028 term. We are grateful to see such strong engagement from the scientific community and deeply appreciate the time and knowledge these...
New general chapter on Quality of data (5.38) published in Issue 12.3 of the European Pharmacopoeia
The European Pharmacopoeia (Ph. Eur.) has published a new general chapter on Quality of data (5.38) in Issue 12.3, following its adoption by the European Pharmacopoeia Commission at its 182nd session in June 2025. Published for information, this chapter addresses the quality of data, with a...
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...
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...
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...
European Pharmacopoeia Issue 12.2 now available
The European Pharmacopoeia (Ph. Eur.) Issue 12.2 is now available and will be applicable in 39 European countries as of 1 April 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...
New quantification method for suspected adulteration with ethylene glycol and diethylene glycol to be included in the Ph. Eur.
In light of continuing reports of paediatric syrups contaminated with ethylene glycol (EG) and diethylene glycol (DEG)...
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