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.

Read More

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...

Read More

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...

Read More

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...

Read More

EN FR

1 new Ph. Eur. reference standard and 29 replacement batches released in January 2024

EDQM 01/02/2024 Strasbourg, France

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...

Read More

EN FR

BSP study outcome published in Pharmeuropa Bio & Scientific Notes – Human tetanus immunoglobulin BRP batch 2

EDQM 29/01/2024 Strasbourg, France

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...

Read More

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...

Read More

EN FR

Ph. Eur. progress in the field of homoeopathic manufacturing methods

EDQM 24/01/2024 Strasbourg, France

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...

Read More

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...

Read More

EN FR

New strategy for N-nitrosamine impurities in Ph. Eur. monographs

EDQM 22/01/2024 Strasbourg, France

At its 177th session in November 2023, the European Pharmacopoeia Commission (EPC) approved the strategy for N-nitrosamine impurities in individual monographs. Regarding active substances The EPC agreed to delete the Production section covering N-nitrosamine impurities from existing individual...

Read More

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.

Read More

EN FR

Survey on strategy for Ph. Eur. quality standards for monoclonal antibodies

EDQM 19/01/2024 Strasbourg, France

In 2014, the European Pharmacopoeia Commission (EPC) launched a pilot phase on setting public standards for therapeutic monoclonal antibodies (mAbs) (“MAB pilot phase”). This pilot phase was intended to explore the feasibility of establishing individual monographs for multi-source mAbs, as well...

Read More

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.

Read More

EN FR

8 replacement batches released in December 2023

EDQM 08/01/2024 Strasbourg, France

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 Chemical Reference Substances (ICRS)...

Read More

EN FR

Pharmeuropa 36.1 just released

EDQM 05/01/2024 Strasbourg, France

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 36.1 is 31 March 2024. Users and interested parties are welcome to comment on these drafts. It should be...

Read More

EN FR

Cannabis flower for system suitability HRS and cannabidiol for cannabis CRS now available

EDQM 03/01/2024 Strasbourg, France

The standards cannabis flower for system suitability HRS and cannabidiol for cannabis CRS that are described in the newly adopted monograph on Cannabis flower (3028) are now available for users under catalogue code Y0002440 and Y0002422 respectively. More information on how to order is available...

Read More

EN FR

EDQM welcomes EU Parliament and Council’s political agreement on enhanced safety and quality for substances of human origin

EDQM 20/12/2023

The European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe welcomes the recent provisional agreement reached between the European Parliament and the Council of the European Union (EU) on the draft regulation on blood, tissues and cells. This marks a pivotal...

Read More

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...

Read More

EN FR

New general chapter on comparability of alternative analytical procedures published in European Pharmacopoeia

EDQM 18/12/2023 Strasbourg, France

A new general chapter, Comparability of alternative analytical procedures (5.27), has been published in Supplement 11.5 of the European Pharmacopoeia (Ph. Eur.). The text was adopted by the European Pharmacopoeia Commission at its 176th session in June 2023. This new general chapter describes how...

Read More

EN FR

BSP study outcome published online – Heparin Low-Molecular-Mass CRS batches 4 & 5

EDQM 18/12/2023 Strasbourg, France

The outcome of the BSP121 study to establish batches 4 and 5 of the European Pharmacopoeia Heparin Low-Molecular-Mass for Calibration Chemical Reference Substance (CRS) has been published in the online journal Pharmeuropa Bio & Scientific Notes and is referenced in Medline/PubMed® (Pharmeur Bio...

Read More

USING THE filter

To help you find the relevant news, filter the list using the categories below.

Activity
Anti-falsification activities
Biological Standardisation Programme (BSP)
Blood
Certification of suitability (CEP)
Classification of medicines
Cosmetics
COVID-19
EDQM
EDQM’s response to nitrosamine contamination
European network of OMCLs
European Pharmacopoeia
Food contact materials and articles
Medicine shortages
Organs, tissues and cells
Paediatric Formulary
Patient & Consumer Protection
Pharmaceutical care
Products and Services
Reference Standards
Tattoos and permanent make-up
Search by year
1996
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Reset Filter