Newsroom
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...
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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...
Certification monthly report of activities: End of October 2024
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of October 2024 Certification Monthly Report For more information, access the Certification Database.
EDQM On Air – Learn how the EDQM protects consumer health
Consumer health protection is an area in which the European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe has played an active role for many years. Everyday products such as cosmetics, food contact materials and tattoo inks fall under its watchful eye. By...
EDQM reference standards newsletter – October 2024
6 new Ph. Eur. reference standards and 24 replacement batches released in October 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 information on new and...
A new era for the European Pharmacopoeia – Online-only format from June 2025
The European Directorate for the Quality of Medicines & HealthCare (EDQM) will launch the online-only European Pharmacopoeia (Ph. Eur.) in June 2025, bringing legally binding European pharmacopoeial standards to subscribers in a modern and easier-to-use format. The discontinuation of the printed...
New EDQM “Guidelines on medication review” just released
“Guidelines on medication review” has just been published by the European Directorate for the Quality of Medicines & HealthCare (EDQM). This work provides essential guidance on medication review processes that will enable healthcare professionals to conduct structured and systematic evaluations...
OMCL Network welcomes Türkiye as a full member
The Analysis and Control Laboratories Department of the Turkish Medicines and Medical Devices Agency has become a full member of the General European OMCL Network (GEON), co-ordinated by the European Directorate for the Quality of Medicines & HealthCare (EDQM). It is the first Turkish official...
Newsletter Transplant 2024 – Organ donation increases globally
A new edition of Newsletter Transplant has just been published, presenting data on donation and transplantation activities worldwide in 2023. This report is produced annually thanks to the invaluable support of the Spanish Organización Nacional de Trasplantes (ONT), which co-ordinates the...
Removal of expiry notifications from the EDQM DCEP Sharing Tool
The EDQM DCEP Sharing Tool is used to share EDQM documents securely between the Certification of Substances Department (DCEP) and CEP holders or applicants. Users receive an e mail with a link when a document is shared with them. Links expire after 60 days, after which time the documents cannot...
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