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EDQM reference standards monthly newsletter – April 2025
1 new European Pharmacopoeia reference standard and 20 replacement batches released in April 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...
Validation of eCTD submissions for CEP applications
Compliance with EU M1 v3.1 and validation criteria v8.1 has been mandatory for all eCTD submissions since 1 March 2025. It has recently become apparent that submissions to the European Directorate for the Quality of Medicines & HealthCare (EDQM) that do not contain the now mandatory tracking...
Public holidays: EDQM offices closures in May 2025
Due to public holidays in France, the European Directorate for the Quality of Medicines & HealthCare (EDQM) will be closed on the following dates: Thursday, 1 May Thursday, 8 May Thursday, 29 May
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DOIX – Simplifying DOI for EDQM experts
The European Directorate for the Quality of Medicines & HealthCare (EDQM) relies on a dedicated community of experts, whose contribution is fundamental to our collective success. To simplify, modernise and centralise procedures for experts’ mandatory declaration of interests (DOI) and...
EPC adopts cutting-edge HTS chapter to enhance viral contaminant detection in biological products
The European Pharmacopoeia Commission (EPC) adopted a new general chapter, High-throughput sequencing for the detection of viral extraneous agents (2.6.41), during its 181st session in March 2025. The new chapter will be published in Issue 12.2 of the European Pharmacopoeia (Ph. Eur.) in October...
EDQM Employment Opportunities – Summer 2025
The European Directorate for the Quality of Medicines & HealthCare (EDQM) is a leading organisation whose mission is to contribute to public health protection by promoting access to safe medicines and healthcare through the elaboration of quality standards, which are recognised as a scientific...
Senior scientific assistant – Official Medicines Control Laboratory (OMCL) Network – Batch release (human and veterinary)
The EDQM’s Networks division is seeking a temporary Senior scientific assistant to join the OMCL Network team responsible for official batch release for human and veterinary medicines.
Technical recommendation of the EDSForm WP: sulfamethoxazole-trimethoprim, paediatric products
Sulfamethoxazole-trimethoprim (also known as co-trimoxazole) is a fixed-dose combination (FDC) of two antibiotics used to treat a number of bacterial infections. Several member states have reported recurring difficulties in procuring this FDC antibiotic, with paediatric forms especially affected....
Save the date: Sterile substance CEP webinar on 4 June 2025
Due to the increasing interest in certificates of suitability for sterile substances, the EDQM would like to invite CEP holders and users to a dedicated webinar on 4 June 2025. The event will shed light on the certification procedure for sterile substances (including GMP aspects) and also provide...
Public holidays: EDQM offices closed from 18 to 21 April 2025
Due to public holidays in France, the European Directorate for the Quality of Medicines & HealthCare (EDQM) will be closed from Friday 18 April to Monday 21 April 2025 included.
Revised general chapters for elemental analysis published in Pharmeuropa 37.2
Analytical procedures for elemental analysis are described in the following European Pharmacopoeia (Ph. Eur.) general chapters: 2.2.22. Atomic emission spectrometry; 2.2.23. Atomic absorption spectrometry; 2.2.57. Inductively coupled plasma-atomic emission spectrometry; 2.2.58. Inductively...
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...
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