Newsroom Certification of suitability
Certification monthly report of activities: End of June 2025
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of June 2025 Certification Monthly Report For more information, access the Certification Database.
CEP holders invited to comment on draft monographs published in Pharmeuropa 37.3
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 37.3. The table below lists the substances...
Tips to improve the quality of your dossier and get a CEP faster
As an applicant using the Certification of suitability to the monographs of the European Pharmacopoeia (CEP) procedure, you play a central role in ensuring the smooth processing of your request. One of the best ways to accelerate the process is by improving the quality of your submission....
Certification monthly report of activities: End of May 2025
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of May 2025 Certification Monthly Report For more information, access the Certification Database.
Join us at CPhI China 2025
The EDQM will be participating at CPhI China, which will take place in Shanghai at the Shanghai New International Expo Centre (SNIEC) on 24-26 June 2025. Visit our stand E1C33 to learn more about the European Pharmacopoeia, our latest publications, what new products will be coming out in the...
“How to read a CEP” – Revised guideline now available!
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published a revised guideline “How to read a CEP”, describing in detail the information that Certificates of suitability to the monographs of the European Pharmacopoeia (CEPs) convey. This document is intended to...
Certification monthly report of activities: End of April 2025
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of April 2025 Certification Monthly Report For more information, access the Certification Database.
“Certified for success” – Register now for the CEP conference
Registrations are now open for our upcoming international conference, “Certified for success: using the CEP Procedure to elevate quality and drive trust”. Don’t miss this unique opportunity to explore the latest developments and future directions of the Certification of suitability to the...
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...
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...
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.
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...
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.
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.
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...