Newsroom
How CEP holders can avoid the rejection of notifications
In order to facilitate the acceptance of proposed changes in a timely manner, CEP holders are reminded that the European Directorate for the Quality of Medicines & HealthCare (EDQM) Guideline on requirements for revision/renewal of Certificates of Suitability to the European Pharmacopoeia...
Senior scientific assistant – Official Cosmetics Control Laboratories Network - ICDN
The EDQM’s Networks division is seeking a temporary Senior scientific assistant to join the OCCL team.
Swan song for general animal safety tests: another significant milestone in the elimination of animal tests from the Ph. Eur.
At its 180th session in November 2024, the European Pharmacopoeia Commission (EPC) decided to suppress the general chapters on Pyrogens (2.6.8), Histamine (2.6.10) and Depressor substances (2.6.11) from the European Pharmacopoeia (Ph. Eur.), all of which require the use of animals. It was also...
Publication of three new Ph. Eur. general chapters for plastic materials for containers
After several years of work by the experts of Group 16 (Plastic materials, plastic containers and closures), three new general chapters on plastic materials were adopted by the European Pharmacopoeia Commission at its 180th session in November 2024. These general chapters – Cyclo-olefin polymers...
EDQM reference standards monthly newsletter – December 2024
3 new European Pharmacopoeia reference standards and 15 replacement batches released in December 2024 The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just published its monthly newsletter on the situation of European Pharmacopoeia reference standards. It includes...
European Pharmacopoeia Commission adopts first three general texts on mRNA vaccines
At its 180th session in November 2024, the European Pharmacopoeia Commission (EPC) adopted three new general texts relating to the production and quality control of mRNA vaccines and their components, namely: mRNA vaccines for human use (5.36), covering mRNA packaged in lipid nanoparticles, i.e....
Pharmeuropa 37.1 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 37.1 is 31 March 2025. Users and interested parties are welcome to comment on these drafts. It should be...
Amiodarone capsules monograph published in European Paediatric Formulary
A new monograph, Amiodarone hydrochloride, capsules (5-200 mg), developed by the European Paediatric Formulary (PaedF) Working Party, been added to the European Paediatric Formulary (Formulary) following a successful public. With the publication of this monograph, the Formulary (which is not...
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...
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...
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