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CEP holders invited to comment on draft monographs published in Pharmeuropa 38.2
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 38.2. The table below lists the substances...
New EDQM guidance on reliance-based or fast-track assessment of CEP applications
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published two new guidelines describing how CEP holders or prospective applicants can request reliance-based or fast-track assessment of their dossiers. The first guideline, “Guidance on requesting reliance-based...
Certification monthly report of activities: End of February 2026
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of February 2026 Certification Monthly Report For more information, access the Certification Database.
Changes to e-submission requirements for CEP applications – Reminder
On 1 November 2025, the EDQM introduced automation to improve its process for receiving CEP submissions. To fully benefit from this automation, applicants must submit the eCTD validation report as requested and in line with the requirements outlined below. While most submissions comply with this...
Certification monthly report of activities: End of January 2026
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of January 2026 Certification Monthly Report For more information, access the Certification Database.
Clarification on the use of the sister file procedure
The current EDQM policy PA/PH/CEP (09) 141, 2R, “Guidance on applications for “sister files”, has guided the sister file procedure for CEPs for many years. Experience gathered over time indicates that there may be discrepancies in the understanding of the procedure and the EDQM has noted that...
Implementation of the European Pharmacopoeia Issue 12.3 – Notification for CEP holders
Issue 12.3 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 2026, and to follow the...
NEW FAQ on how to present the specification for a substance in a CEP application
As part of our continuous commitment to improving processes and to better support applicants in preparing compliant, complete and properly documented CEP submissions, the EDQM has published a new FAQ entitled “How to present the specification for a substance in a CEP application?” This new FAQ...
Certification monthly report of activities: End of December 2025
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of December 2025 Certification Monthly Report For more information, access the Certification Database.
CEP holders invited to comment on draft monographs published in Pharmeuropa 38.1
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 38.1. The table below lists the substances...
Certification monthly report of activities: End of November 2025
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of November 2025 Certification Monthly Report For more information, access the Certification Database.
EDQM releases draft revised “Guideline on requirements for revision/renewal of certificates of suitability to the European Pharmacopoeia monographs” – for public consultation
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has revised the “Guideline on requirements for revision and renewal of certificates of suitability to the European Pharmacopoeia monographs” (PA/PH/CEP (04) 02) to align it with the requirements of the applicable revised EU...
Certified for Success: highlights from the CEP conference
The EDQM conference “Certified for success: using the CEP Procedure to elevate quality and drive trust”, held on 23 and 24 September 2025, brought together over 125 participants (representing 25 countries) from across the pharmaceutical and chemical industries, regulatory agencies and academia to...
Certification monthly report of activities: End of October 2025
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of October 2025 Certification Monthly Report For more information, access the Certification Database.
EDQM clarifies the stepwise process to getting a CEP or having a change approved
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published a new document called “Stepwise process to get a CEP or having a change approved”. This document is intended to clarify, for all types of application, the process and steps for obtaining a certificate of...
Implementation of the European Pharmacopoeia Issue 12.2 – Notification for CEP holders
Issue 12.2 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 April 2026, and to follow the...
Changes to e-submission requirements for CEP applications
The EDQM will soon be introducing automation to improve its process for receiving CEP submissions. As of 1 November 2025, applicants will have to comply with the following requirements: The eCTD validation report must be provided as part of eCTD submissions: Submissions with eCTD sections must be...
Certification monthly report of activities: End of September 2025
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of September 2025 Certification Monthly Report For more information, access the Certification Database.
Regulatory Reliance and Fast track assessment in the CEP procedure
According to the World Health Organization (WHO), “Good reliance practices are anchored in overall good regulatory practices (GRP), which provide a means for establishing sound, affordable, effective regulation of medical products as an important part of health system strengthening. If...
CEP holders invited to comment on draft monographs published in Pharmeuropa 37.4
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 37.4. The table below lists the substances...
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