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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...
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...
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...
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...
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...
EPC adopts mycoplasmas general chapter and monographs, updated to incorporate latest analytical developments
During its 181st session in March 2025, the European Pharmacopoeia Commission (EPC) adopted general chapter 2.6.7. Mycoplasmas and 11 monographs referring to it, all of which have been revised to reflect the new European Pharmacopoeia (Ph. Eur.) approach to the detection of mycoplasma...
EPC adopts cutting-edge HTS chapter to enhance viral contaminant detection in biological products
The European Pharmacopoeia Commission (EPC) adopted a new general chapter, High-throughput sequencing for the detection of viral extraneous agents (2.6.41), during its 181st session in March 2025. The new chapter will be published in Issue 12.2 of the European Pharmacopoeia (Ph. Eur.) in October...
Revised general chapters for elemental analysis published in Pharmeuropa 37.2
Analytical procedures for elemental analysis are described in the following European Pharmacopoeia (Ph. Eur.) general chapters: 2.2.22. Atomic emission spectrometry; 2.2.23. Atomic absorption spectrometry; 2.2.57. Inductively coupled plasma-atomic emission spectrometry; 2.2.58. Inductively...
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