Newsroom European Pharmacopoeia
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...
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...
182nd session of the European Pharmacopoeia Commission: handover to a new Chair, newly elected Presidium and launch of the all-digital 12th Edition
The European Pharmacopoeia Commission (EPC) held its 182nd session on 17 and 18 June 2025. A summary of its outcome is available in the infographic below. Highlights will be published shortly on our website and the full list of adopted texts will be made available on the European Pharmacopoeia...
Pharmeuropa 37.3 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 37.3 is 30 September 2025. Users and interested parties are welcome to comment on these drafts. It...
All-digital 12th Edition marks a new era for the European Pharmacopoeia
The European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe is proud to announce the launch of the 12th Edition of the European Pharmacopoeia (Ph. Eur.). This edition – much more than just another number – ushers in a new, all-digital era for the primary...
EDQM On Air – A win for animals – Phasing out the rabbit pyrogen test
EDQM On Air, the podcast on public health brought to you by the European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe, has just released a new episode! The EDQM is committed to improving animal welfare in the context of scientific experiments and testing....
Renew your European Pharmacopoeia access
The launch of the new European Pharmacopoeia (Ph. Eur.) online platform marks the beginning of a new era for the Ph. Eur. Renew your licence today to consult the Ph. Eur. texts you need on a redesigned, user-friendly platform launched alongside the 12th Edition. In the new publication cycle, each...
Join us at CPhI China 2025
The EDQM will be participating at CPhI China, which will take place in Shanghai at the Shanghai New International Expo Centre (SNIEC) on 24-26 June 2025. Visit our stand E1C33 to learn more about the European Pharmacopoeia, our latest publications, what new products will be coming out in the...
Launch of the 12th Edition and new online-only platform
Step into the future with us as we launch the all-digital 12th edition of the European Pharmacopoeia (Ph. Eur.), soon available exclusively on a new online platform. This significant transition marks the end of the print version and the beginning of a new era for the European Pharmacopoeia, one...
Pharmacopoeial Discussion Group achievements
The Pharmacopoeial Discussion Group (PDG)1 held its interim videoconference on 6 March 2025. The discussions focused on the next phase of PDG’s global membership expansion initiative. As previously announced (“PDG announces global membership initiative”), the PDG launched this initiative in...