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Certification monthly report of activities: End of March 2025
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of March 2025 Certification Monthly Report For more information, access the Certification Database.
Public consultation on revised general chapter 5.1.6. Alternative methods for control of microbiological quality in Pharmeuropa 37.2
The European Pharmacopoeia (Ph. Eur.) is seeking stakeholder feedback on the revised general chapter 5.1.6. Alternative methods for control of microbiological quality, published in this quarter’s issue of Pharmeuropa 37.2 for comment. This chapter aims to facilitate the implementation of rapid...
EPC adopts groundbreaking chapter on cell-based preparations for human use
After several years of work by the Cell Therapy Products Working Party (CTP WP), the European Pharmacopoeia Commission (EPC) adopted the new general chapter Cell-based preparations for human use (5.32) during its 181st session in March 2025. The new chapter will be published in Issue 12.2 of the...
Outcome of the 181st session of the European Pharmacopoeia Commission, March 2025
The European Pharmacopoeia Commission (EPC) held its 181st session on 25 and 26 March 2025. A summary of its outcome is available in the infographic below. Highlights will be published shortly on our website and the full list of adopted texts will be made available on the European Pharmacopoeia...
Alain Berset: “Health is our most precious gift, and a top concern for all Europeans”
Ahead of the World Health Day (7 April), Council of Europe Secretary General Alain Berset has made the following statement: “Health is our most precious gift — and a top concern for all Europeans. For the Council of Europe, health is also a fundamental human right, protected by our two main human...
EDQM reference standards monthly newsletter – March 2025
4 new European Pharmacopoeia reference standard and 12 replacement batches released in March 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...
CEP holders invited to comment on draft monographs published in Pharmeuropa 37.2
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 37.2. The table below lists the substances...
Pharmeuropa 37.2 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 37.2 is 30 June 2025. Users and interested parties are welcome to comment on these drafts. It should be...
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...
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...
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.
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