Newsroom Certification of suitability
Council of Europe Health Protection Conference 2025 – recording and spotlight on Session 3
The Conference on the Protection of Health brought together experts, regulators and stakeholders to showcase the Council of Europe’s holistic, rights-based and ethical approach to protecting health and to explore how this approach could be reinforced in a changing public-health landscape marked...
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...
EDQM webinar on how to read a CEP for all users
The European Directorate for the Quality of Medicines & HealthCare (EDQM) will hold a free webinar on 25 November 2025 for all interested users of Certificates of suitability to the monographs of the European Pharmacopoeia (CEPs), following up on the recently revised guideline “How to read a...
Join us at CPhI Worldwide in Frankfurt 2025!
Visit the stand 11.1 B27 at CPhI Frankfurt to meet the European Directorate for the Quality of Medicines & HealthCare (EDQM) team from 28 to 30 October 2025. Curious about the new European Pharmacopoeia platform or the EDQM reference standards? Want to find out about new products scheduled for...
Certification monthly report of activities: End of August 2025
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of August 2025 Certification Monthly Report For more information, access the Certification Database.
Certified for success: complete CEP conference programme now available
The complete programme of the international conference “Certified for success: using the CEP Procedure to elevate quality and drive trust” – taking place on the 23 and 24 September 2025 – is now available. Find out more about this unique opportunity to explore the latest developments and future...
Certification monthly report of activities: End of July 2025
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of July 2025 Certification Monthly Report For more information, access the Certification Database.
Implementation of the 12th Edition of the European Pharmacopoeia – Notification for CEP holders
The 12th Edition 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 January 2026, and to follow the...
2024 EDQM annual report showcases our unwavering dedication to improving public health
The European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe has published its 2024 annual report. Once again, the report attests to our strong commitment to making better healthcare accessible for all and provides a comprehensive overview of the challenges...
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.