EN FR

Certification monthly report of activities: End of January 2024

EDQM 09/02/2024 Strasbourg, France

The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of January 2024 Certification Monthly Report For more information, access the Certification Database.

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EN FR

Read the top 10 deficiencies observed in new CEP applications for chemical purity assessed in 2023 to improve the quality of your applications!

EDQM 08/02/2024 Strasbourg, France

This document is a summary of the top ten deficiencies identified after the initial evaluation of new applications for Certificates of Suitability (CEP) for chemical purity. The content of this document is intended to help applicants to build their application in conjunction with the EDQM...

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EN FR

EDQM’s ISO 9001:2015 certification maintained

EDQM 08/02/2024 Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare’s (EDQM) ISO 9001:2015 certificate has been maintained following the second surveillance audit of its quality management system on 28 and 29 November 2023 by the official French standardisation body Association française de...

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EN FR

Save the date: EDQM conference celebrating 60 years of excellence in public health protection

EDQM 18/01/2024 Strasbourg, France

In 2024, the European Directorate for the Quality of Medicines & HealthCare (EDQM) is celebrating 60 years of excellence in the protection and promotion of public health. We are delighted to announce the organisation of a conference to mark this occasion, on 11 and 12 June 2024, in Strasbourg...

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EN FR

The template of Quality Overall Summary (QOS) to be submitted for Certification applications has been adapted to the current needs!

EDQM 25/01/2024 Strasbourg, France

A new version of the QOS template is now available. It may be used from January 2024 and will become mandatory as of April 2024. The QOS (eCTD Module 2) has to be provided along with an initial submission since it is essential in the review of a new CEP application. This updated template gives...

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EN FR

CEP holders invited to comment on draft monographs published in Pharmeuropa 36.1

EDQM 22/01/2024 Strasbourg, France

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 36.1. The table below lists the substances...

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EN FR

EDQM clarifies its policy for confidentiality and declassification of CEP documents

EDQM 19/01/2024 Strasbourg, France

EDQM has elaborated a document describing the principles for the declassification of documents pertaining to the CEP procedure while ensuring when necessary, the confidentiality of information.

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EN FR

Certification monthly report of activities: End of December 2023

EDQM 09/01/2024 Strasbourg, France

The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of December 2023 Certification Monthly Report For more information, access the Certification Database.

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EN FR

Implementation of the European Pharmacopoeia Supplement 11.5 – Notification for CEP holders

EDQM 19/12/2023 Strasbourg, France

Supplement 11.5 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 2024, and to follow the...

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EN FR

The CEP 2.0 guideline on requirements for the content of the dossier has been updated

EDQM 13/12/2023 Strasbourg, France

The guideline on requirements for the content of the CEP dossier according to the CEP 2.0 has been revised to include updated requirements and clarifications related to sections 3.2.S.4.1 & 3.2.S.4.2. and an updated Annex 1.

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EN FR

Information for CEP applicants - EDQM-DCEP non-working days in 2024

EDQM 11/12/2023 Strasbourg, France

In order to facilitate the calculation of the timelines as described in the policy document “Management of applications for new Certificates of Suitability, Requests for Revision or Renewal of Certificates of Suitability and applications using the ‘sister files’ procedure” (PA-PH-CEP (13) 110,...

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EN FR

Certification monthly report of activities: End of November 2023

EDQM 07/12/2023 Strasbourg, France

The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of November 2023 Certification Monthly Report For more information, access the Certification Database.

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EN FR

Reminder: Use of EMA SPOR/OMS ORG_ID and LOC_ID mandatory for any CEP applications

EDQM 04/12/2023 Strasbourg, France

Since 1 June 2023, applicants must provide in the application forms for any type of submission (new dossiers, sister files, revisions and renewals) the EMA SPOR/OMS ORG_ID and LOC_ID (unique identifiers for an organisation and its locations) for all companies involved in Certification of...

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EN FR

Certification monthly report of activities: End of October 2023

EDQM 10/11/2023 Strasbourg, France

The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of October 2023 Certification Monthly Report For more information, access the Certification Database.

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EN FR

CEP 2.0: new requirements for the content of the chemical purity and herbal drugs/herbal drug preparation dossiers

EDQM 09/11/2023 Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare (EDQM) wishes to provide further clarification regarding the presentation and content of the “Specification” section (3.2.S.4.1) to all applicants preparing an application in CEP 2.0 format. When completing section 3.2.S.4.1,...

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EN FR

Certification monthly report of activities: End of September 2023

EDQM 06/10/2023 Strasbourg, France

The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of September 2023 Certification Monthly Report For more information, access the Certification Database.

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EN FR

CEP holders invited to comment on draft monographs published in Pharmeuropa 35.4

EDQM 06/10/2023 Strasbourg, France

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 35.4. The table below lists the substances...

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EN FR

Implementation of the European Pharmacopoeia Supplement 11.4 – Notification for CEP holders

EDQM 06/10/2023 Strasbourg, France

Supplement 11.4 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 2024, and to follow the...

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EN FR

CEP 2.0 – Certificates of suitability: electronic signature features

EDQM 21/09/2023 Strasbourg, France

On 1 September 2023, the European Directorate for the Quality of Medicines & HealthCare (EDQM) implemented electronic signatures for CEPs and some other documents as part of the CEP 2.0 project. A document explaining the features of electronic signatures is now available on our website:...

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EN FR

Changes to the acceptability of CEP applications for sterile grade materials

EDQM 21/09/2023 Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare (EDQM) is updating its policy concerning the acceptability of CEP applications for sterile active substances. Until now, acceptability requirements have applied to the manufacturing processes only when the manufacturer of the...

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