Newsroom
Certification monthly report of activities: End of February 2025
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of February 2025 Certification Monthly Report For more information, access the Certification Database.
EDQM Stakeholder Event on Plasma Supply Continuity – Programme available
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just released the programme for the upcoming stakeholder event on plasma supply continuity. Dedicated to the goal of increasing and improving plasma supply in Europe, this event will take place on 26 and 27 March 2025...
EDQM reference standards monthly newsletter – February 2025
1 new European Pharmacopoeia reference standard and 22 replacement batches released in February 2025 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...
EDQM On Air – AI in healthcare – Innovations, ethics and the road ahead, with Eric Sutherland
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! Artificial intelligence (AI) is a source of great hope in healthcare. Properly applied, it has the...
Division Administrative Assistant
The EDQM’s Administration & Finance Division (DAF) is seeking a temporary Administrative Assistant as of 15 March until the end of 2025.
Online publication of study for establishment of Ph. Eur. Human anti-D immunoglobulin BRP batch 2
The EDQM’s Biological Standardisation Programme, a joint programme of the Council of Europe and the European Commission, has recently run a study to establish batch 2 of the European Pharmacopoeia (Ph. Eur.) Human anti-D immunoglobulin Biological Reference Preparation (BRP). The outcome of the...
International collaboration for public health protection – EDQM welcomes African partners
The European Directorate for the Quality of Medicines & HealthCare (EDQM) recently welcomed representatives from the African Medicines Regulatory Harmonisation Secretariat, the African Medicines Quality Forum (AMQF) and the Gates Foundation to Strasbourg for a study visit. This gathering marked...
Certification monthly report of activities: End of January 2025
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of January 2025 Certification Monthly Report For more information, access the Certification Database.
Online publication on study for establishment of new Golimumab BRP
The outcome of a successful Biological Standardisation Programme study (BSP164) for the establishment of a new European Pharmacopoeia (Ph. Eur.) Biological Reference Preparation (BRP) for golimumab, a fully human therapeutic TNF targeting monoclonal antibody, has been published in the online...
Strengthening European SoHO systems – The Council of Europe and European Union step-up co-operation
The European Directorate for the Quality of Medicines & HealthCare (EDQM), of the Council of Europe, and the European Union (EU) have just signed a new agreement aimed at further enhancing substances of human origin (SoHO) systems and strengthening their capacity across Europe and beyond. Through...
EDQM reference standards monthly newsletter – January 2025
7 new European Pharmacopoeia reference standards and 20 replacement batches released in January 2025 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...
EDQM On Air – COVID-19: Rising to the challenge of a global crisis
EDQM On Air, the podcast from the European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe, has just released a new episode! The SARS-CoV-2 virus, which causes COVID-19, triggered a global pandemic on a staggering scale in 2020. It brought entire societies to...
Recommendation CM/Rec(2024)8 on the family approach to discuss deceased organ and tissue donation
The Committee of Ministers of the Council of Europe adopted Recommendation CM/Rec(2024)8 on the family approach to discuss deceased organ and tissue donation on 27 November 2024. This instrument promotes a family-centred approach to discussing organ and tissue donation after a person’s death....
Pharmacopoeial Discussion Group achievements
The Pharmacopoeial Discussion Group (PDG) held its annual meeting on 1 and 2 October 2024 in Strasbourg, France. The meeting marked the one-year anniversary of the PDG working with an expanded team of four members (see “PDG welcomes IPC as a member”). The PDG includes the European Pharmacopoeia...
Publication of BSP establishment study for hepatitis A virus coating reagent BRR
The Biological Standardisation Programme (BSP) recently established batch 2 of the Ph. Eur. Hepatitis A virus Coating Reagent Biological Reference Reagent (BRR) for use in the in vitro potency assay of hepatitis A vaccines by ELISA. The BRR was established in an international collaborative study...
Certification monthly report of activities: End of December 2024
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of December 2024 Certification Monthly Report For more information, access the Certification Database.
Implementation of the European Pharmacopoeia Supplement 11.8 – Notification for CEP holders
Supplement 11.8 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 2025, and to follow the...
CEP holders invited to comment on draft monographs published in Pharmeuropa 37.1
Holders of Certificates of suitability to the monographs of the European Pharmacopoeia (CEPs) are requested to consult the list of substances for which draft revised monographs of the European Pharmacopoeia (Ph. Eur.) have been published in Pharmeuropa 37.1. The table below lists the substances...
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...
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...
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