Newsroom
European Paediatric Formulary: Isoniazid 50 mg/mL oral solution monograph in public consultation
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just released Issue 10 of Pharmeuropa PaedForm, containing the 11th monograph of the PaedF Working Party, Isoniazid 50 mg/mL oral solution, for public consultation. The deadline for comments is 30 June 2025. The...
Modernising excipient monographs: revised identification techniques and new CRSs
In recent months, several revised excipient monographs and new reference standards have been added to the European Pharmacopoeia (Ph. Eur.). The aim of the changes is to support users by promoting modern IR identification techniques and replacing reference spectra with chemical reference...
Temporary Scientific Assistant B3/B4
Do you have chemical synthesis, regulatory or analytical chemistry skills? Do you have a passion for scientific evaluation and compliance?
EDQM On Air – The evolution of biologicals in the European Pharmacopoeia
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! Biological medicinal products – or biologicals – are a class of pharmaceutical products derived or...
Save the date! International conference on the EDQM’s CEP procedure
Since 1994 , the procedure for the Certification of suitability to the monographs of the European Pharmacopoeia (CEP procedure ) has made a significant contribution to building trust in the pharmaceutical field around the world . Join us on 23-24 September 2025 in the vibrant and historic city of...
Head of Resources Department
Become the Head of the Resources Department at EDQM!
Reminder: Use of EMA SPOR/OMS ORG_ID and LOC_ID mandatory for CEP applications
As part of the implementation of the CEP 2.0, it is mandatory as of 1 June 2023 to provide, in the application forms for new dossiers, sister files and revisions and renewals, the EMA SPOR/OMS ORG_ID and LOC_ID for all companies involved in Certification of suitability (CEP) dossiers. Revised...
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...
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...
To help you find the relevant news, filter the list using the categories below.