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Pharmeuropa 36.2 just released
All new European Pharmacopoeia (Ph. Eur.) texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments on Pharmeuropa 36.2 is 30 June 2024. Users and interested parties are welcome to comment on these drafts. It should be...
As a CEP applicant, you want to improve the quality of your dossier? The revised EDQM guideline “content of the dossier” and other key documents will be useful tools
The revised version of the EDQM guideline “Content of the dossier for chemical purity and microbiological quality of substances for pharmaceutical use” is now available and will be implemented as of 1 May 2024. This guideline and other key documents (QOS, top ten deficiencies), as well as the use...
7 new Ph. Eur. reference standard and 17 replacement batches released in March 2024
New Ph. Eur. reference standards and Replacement batches for Ph. Eur. reference standards Distribution quota Removal Future removal Change of sales units Information on change of amount per unit Information on change of price Change of EDQM storage/shipping conditions Information on International...
Cannabidiol impurity J CRS now available
The standard cannabidiol impurity J CRS that is described in the monograph on Cannabidiol (3151) is now available for users under catalogue code Y0002436. More information on how to order is available on the EDQM website.
Revised Regulation for the Ozone-Depleting Substances
Regulation (EU) 2024/590 on substances that deplete the ozone layer entered into force on 11 March 2024. The rules governing the placing on the market and use of ozone-depleting substances (ODSs) for essential laboratory and analytical uses have now changed. Under the new regulation, standards...
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...
First OMCL analytical procedures for determination of nitrosamine drug substance-related impurities (NDSRIs) and intermediate-related contaminants published
The official medicines control laboratories (OMCLs) of the General European OMCL Network (GEON) began developing procedures for the determination of N-nitrosamine contaminants in 2018. The resulting procedures have been published for information on the website of the European Directorate for the...
Stakeholder consultation – New draft technical guide on FCM compliance
Stakeholder consultation – New draft technical guide on FCM compliance A new draft technical guide on documentation supporting compliance and safety of food contact materials and articles is now open for comment. The European Directorate for the Quality of Medicines & HealthCare (EDQM) invites...
The template of Quality Overall Summary (QOS) to be submitted for Certification applications has been adapted to the current needs!
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...
Certification monthly report of activities: End of February 2024
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of February 2024 Certification Monthly Report For more information, access the Certification Database.
1 new Ph. Eur. reference standard and 15 replacement batches released in February 2024
New Ph. Eur. reference standards and Replacement batches for Ph. Eur. reference standards Distribution quota Removal Future removal Change of sales units Information on change of amount per unit Information on change of price Change of EDQM storage/shipping conditions Information on International...
Two new monographs published in European Paediatric Formulary
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has added two new monographs Clonidine hydrochloride 10 µg/mL oral solution and Furosemide 2 mg/mL oral solution, to the European Paediatric Formulary after a successful public consultation phase. The Formulary now...
Stakeholder consultation – Draft documents to support safe and correct use of herbal food supplements
From 23 February 2024 to 5 April 2024, the European Directorate for the Quality of Medicines & HealthCare (EDQM) is undertaking a targeted consultation to seek the opinions of interested parties on a draft guidance document for healthcare professionals and a draft leaflet for patients/consumers...
Save the date: webinar on CEP 2.0
The EDQM invites CEP holders and users to participate in a public webinar on the 9th April 2024 to share their experiences on the use of CEP 2.0. More info at: https://www.edqm.eu/en/cep-2-0-fresh-feedback-from-stakeholders
Certification monthly report of activities: End of January 2024
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.
Read the top 10 deficiencies observed in new CEP applications for chemical purity assessed in 2023 to improve the quality of your applications!
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...
EDQM’s ISO 9001:2015 certification maintained
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...
1 new Ph. Eur. reference standard and 29 replacement batches released in January 2024
New Ph. Eur. reference standards and Replacement batches for Ph. Eur. reference standards Distribution quota Removal Future removal Change of sales units Information on change of amount per unit Information on change of price Change of EDQM storage/shipping conditions Information on International...
BSP study outcome published in Pharmeuropa Bio & Scientific Notes – Human tetanus immunoglobulin BRP batch 2
The outcome of the Biological Standardisation Programme study BSP140 to establish the European Pharmacopoeia (Ph. Eur.) Biological Reference Preparation (BRP) for Human tetanus immunoglobulin batch 2 has been published in the online journal Pharmeuropa Bio & Scientific Notes of the European...
Ph. Eur. progress in the field of homoeopathic manufacturing methods
The European Directorate for the Quality of Medicines & HealthCare (EDQM) is proud to highlight the remarkable progress made in 2023 on European Pharmacopoeia (Ph. Eur.) texts on homoeopathic manufacturing methods, with the recent publication (January 2024) of three revised general monographs in...
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