Newsroom
2024, a year to remember
A busy and eventful year comes to a close for the European Directorate for the Quality of Medicines & HealthCare (EDQM), and it is time to look back, take stock of our successes and accomplishments and peek into the new year to see what challenges and opportunities await. The 60th anniversary of...
Compliance and safety of food contact materials and articles – New EDQM guide available
The European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe has published the “Technical guide on documentation supporting compliance and safety of food contact materials and articles”. This new user-friendly guide, designed to help business operators...
Online publication of Erythropoietin CRS establishment study
Batch 2 of the European Pharmacopoeia (Ph. Eur.) Erythropoietin for physicochemical tests Chemical Reference Substance (CRS) was adopted by the Ph. Eur. Commission in November 2023. This CRS is used as a reference for capillary zone electrophoresis, peptide mapping, and polyacrylamide gel...
26-27 March 2025
EDQM stakeholder event - Plasma Supply Continuity
SAVE THE DATE! Join us for an important stakeholder event on the theme “Plasma Supply Continuity”. Hosted by the European Directorate for the Quality of Medicines & HealthCare (EDQM), this in-person forum will take place in Strasbourg on 26 and 27 March 2025. This event will provide an update on...
New FAQ on EDQM HelpDesk: system suitability test in assay chromatographic procedures
Following queries received from users through the EDQM HelpDesk, a new FAQ on the system suitability test (selectivity) in assays by chromatographic procedures has been added to the existing series of FAQs dealing with the European Pharmacopoeia & International harmonisation. This addition is...
European Pharmacopoeia Supplement 11.8 now available
The European Pharmacopoeia (Ph. Eur.) Supplement 11.8 is now available and will be applicable in 39 European countries as of 1 July 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 versions...
End-of-year holidays: EDQM offices closed from 24 December 2024 (noon) to 1 January 2025
Due to the end-of-year holidays, the European Directorate for the Quality of Medicines & HealthCare (EDQM) will be closed 24 December (noon) 2024 to 1 January 2025 included. Normal business hours will resume on Thursday, 2 January 2025.
Information for CEP applicants - EDQM-DCEP non-working days in 2025
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,...
CEP Procedure: 30 years of scientific excellence
This year marks the 30th anniversary of the Certification of suitability to the monographs of the European Pharmacopoeia (CEP) Procedure, established by the European Directorate for the Quality of Medicines & HealthCare (EDQM). Since 1994, the CEP procedure has significantly contributed to the...
New addition to the work programme of the European Paediatric Formulary
The European Pharmacopoeia Commission approved the addition of a new monograph on Pyridoxine, oral liquid to the European Paediatric Formulary work programme at its session in November 2024. The complete work programme is available here . Interested parties may contact the Secretariat to propose...
Certification monthly report of activities: End of November 2024
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of November 2024 Certification Monthly Report For more information, access the Certification Database.
European Drug Shortages Formulary project: approval of framework and procedure documents
The European Drug Shortages Formulary (EDSForm) project plays a key role in the EDQM’s efforts to address medicine shortages in Europe. With work led by the European Drug Shortages Formulary Working Party (EDSForm WP), the aim of the project is to provide guidance for hospital and community...
Collaborative study on validation of an ELISA method for determination of physical particle titre of AAV2 vectors: outcome published
The Gene Therapy Working Group (GTWG) of the General European Official Medicines Control Laboratory (OMCL) Network (GEON) organises collaborative studies to validate analytical methods for the quality control of gene therapy products. A recent study focused on the validation of an ELISA method...
Increasing the EDQM’s global impact: Brazilian health authority to rely on CEP evaluation procedure
In a decision advancing international convergence in pharmaceuticals worldwide, the Brazilian health regulatory authority, Agência Nacional de Vigilância Sanitária (ANVISA), has decided to consider evaluation reports from international regulatory bodies in their decision-making process . This...
EDQM reference standards monthly newsletter – November 2024
5 new European Pharmacopoeia reference standard and 17 replacement batches released in November 2024 The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just published its monthly report on the situation of European Pharmacopoeia reference standards. It includes...
Outcome of the 180th session of the European Pharmacopoeia Commission, November 2024
The European Pharmacopoeia Commission (EPC) held its 180th session on 19 and 20 November 2024. A summary of its outcome is available in the infographic below. Highlights will be published shortly on the website of the European Directorate for Quality of Medicines & HealthCare (EDQM) and the full...
CEPs for sterile substances – Guideline for preparing your dossier now available
The European Directorate for the Quality of Medicines & HealthCare (EDQM) wishes to provide further guidance to applicants for the preparation of their dossiers to obtain a Certificate of Suitability (CEP) for a sterile substance. This document clarifies the conditions for acceptability of this...
General chapter Elemental Impurities (G-07) harmonised by the Pharmacopoeial Discussion Group
The new harmonised general chapter “Elemental Impurities (G-07)” was signed-off by the Pharmacopoeial Discussion Group (PDG) on 19 June 2024. The PDG brings together the European Pharmacopoeia (Ph. Eur.), Indian Pharmacopoeia Commission (IPC), Japanese Pharmacopoeia (JP) and the United States...
EDQM On Air – Discover the vast international network working to protect your public health
The European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe works with many national and international stakeholders for the protection of public health. Tune in now to find out more about their collaboration and the real-life outcomes of their work by...
EDQM end-of-year closure: order and shipment deadlines
Order and shipment deadlines have been established for publications and reference standards, taking into account the closure of the European Directorate for the Quality of Medicines & HealthCare (EDQM) offices from Tuesday 24 December 2024 (12 noon CET) to Tuesday 2 January 2025 (8 a.m. CET). The...
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