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Article on joint WHO/EDQM establishment study for Prekallikrein activator in albumin reference standards now online
The outcome of the successful study to establish the European Pharmacopoeia (Ph. Eur.) Biological Reference Preparation (BRP) for Prekallikrein activator in albumin batch 7 has been published in the scientific journal Pharmeuropa Bio & Scientific Notes. The study (BSP153) was organised jointly by...
Outcome of the 179th session of the European Pharmacopoeia Commission, June 2024
The European Pharmacopoeia Commission (EPC) held its 179th session on 18 and 19 June 2024. 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 Ph. Eur. Work Programme...
European Pharmacopoeia Supplement 11.6 now available
The European Pharmacopoeia (Ph. Eur.) Supplement 11.6 is now available and will be applicable in 39 European countries as of 1 January 2025. This volume is included in the 2025 subscription (11.6, 11.7 and 11.8) to the 11th Edition of the Ph. Eur. Subscriptions for print and/or electronic...
NEW 4th Training Course on Quality Management for Tissue Establishments
A robust quality management system (QMS) is key to ensuring the efficacy, quality and safety of tissues and cells for human application. Tissue establishments (TEs) need to implement a QMS to ensure that tissues and cells for human application comply with the applicable technical and legal...
Public consultation on new general chapter on High-throughput sequencing for the detection of viral extraneous agents in Pharmeuropa 36.2
The European Pharmacopoeia (Ph. Eur.) is seeking stakeholder feedback on its new general chapter, HTS for the detection of viral extraneous agents (2.6.41), published in this quarter’s issue of Pharmeuropa (36.2) for comment. High-Throughput Sequencing (HTS, also known as Next-Generation...
5 new Ph. Eur. reference standard and 20 replacement batches released in April 2024
New Ph. Eur. reference standards and Replacement batches for Ph. Eur. reference standards Distribution quota Removal Future removal Change of sales units Information on change of amount per unit Information on change of price Change of EDQM storage/shipping conditions Information on International...
JP and Ph. Eur. launch a bilateral prospective harmonisation project for active substance and medicinal product monographs
The Japanese Pharmacopoeia (JP) and the European Pharmacopoeia (Ph. Eur.) are pleased to announce the launch of a bilateral prospective harmonisation project targeting pharmacopoeial standards for active substances and medicinal products. Pharmacopeial harmonisation serves to further reduce the...
1 new Ph. Eur. reference standard and 29 replacement batches released in January 2024
New Ph. Eur. reference standards and Replacement batches for Ph. Eur. reference standards Distribution quota Removal Future removal Change of sales units Information on change of amount per unit Information on change of price Change of EDQM storage/shipping conditions Information on International...
EDQM clarifies its policy for confidentiality and declassification of CEP documents
EDQM has elaborated a document describing the principles for the declassification of documents pertaining to the CEP procedure while ensuring when necessary, the confidentiality of information.
Cannabis flower for system suitability HRS and cannabidiol for cannabis CRS now available
The standards cannabis flower for system suitability HRS and cannabidiol for cannabis CRS that are described in the newly adopted monograph on Cannabis flower (3028) are now available for users under catalogue code Y0002440 and Y0002422 respectively. More information on how to order is available...
EDQM welcomes EU Parliament and Council’s political agreement on enhanced safety and quality for substances of human origin
The European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe welcomes the recent provisional agreement reached between the European Parliament and the Council of the European Union (EU) on the draft regulation on blood, tissues and cells. This marks a pivotal...
Implementation of the European Pharmacopoeia Supplement 11.5 – Notification for CEP holders
Supplement 11.5 of the European Pharmacopoeia (Ph. Eur.) is now available. Holders of Certificates of suitability to the monographs of the Ph. Eur. (CEPs) are invited to update their applications according to the revised monographs that will be implemented on 1 July 2024, and to follow the...
New general chapter on comparability of alternative analytical procedures published in European Pharmacopoeia
A new general chapter, Comparability of alternative analytical procedures (5.27), has been published in Supplement 11.5 of the European Pharmacopoeia (Ph. Eur.). The text was adopted by the European Pharmacopoeia Commission at its 176th session in June 2023. This new general chapter describes how...
BSP study outcome published online – Heparin Low-Molecular-Mass CRS batches 4 & 5
The outcome of the BSP121 study to establish batches 4 and 5 of the European Pharmacopoeia Heparin Low-Molecular-Mass for Calibration Chemical Reference Substance (CRS) has been published in the online journal Pharmeuropa Bio & Scientific Notes and is referenced in Medline/PubMed® (Pharmeur Bio...
General chapters on powder characterisation techniques modernised
The European Directorate for the Quality of Medicines & HealthCare (EDQM) is proud to highlight the remarkable progress made in 2023 on five general chapters of the European Pharmacopoeia (Ph. Eur.) that cover procedures for powder characterisation. The three revised and two newly elaborated...
European Pharmacopoeia Supplement 11.5 now available
The European Pharmacopoeia (Ph. Eur.) Supplement 11.5 is now available and will be applicable in 39 European countries as of 1 July 2024. This volume is included in the 2024 subscription (11.3, 11.4 and 11.5) to the 11th Edition of the Ph. Eur. Subscriptions for print and/or electronic versions...
Implementation of pharmaceutical care in daily practice in South-eastern Europe Health Network (SEEHN) member states
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just published the results of a survey conducted in 2022 among states who are members of both the South-eastern Europe Health Network (SEEHN) and the Council of Europe. The main objective of this initiative was to...
The CEP 2.0 guideline on requirements for the content of the dossier has been updated
The guideline on requirements for the content of the CEP dossier according to the CEP 2.0 has been revised to include updated requirements and clarifications related to sections 3.2.S.4.1 & 3.2.S.4.2. and an updated Annex 1.
European Pharmacopoeia welcomes Egyptian Drug Authority as observer
The Egyptian Drug Authority has been granted observer status to the European Pharmacopoeia Commission (EPC). This decision demonstrates the dynamism of the European Pharmacopoeia (Ph. Eur.), which now has 33 observers from around the world in addition to 39 European countries and the European...
Information for CEP applicants - EDQM-DCEP non-working days in 2024
In order to facilitate the calculation of the timelines as described in the policy document “Management of applications for new Certificates of Suitability, Requests for Revision or Renewal of Certificates of Suitability and applications using the ‘sister files’ procedure” (PA-PH-CEP (13) 110,...
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