EDQM Open Day – Join us for an afternoon full of discovery

EDQM 02/05/2024 Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare (EDQM) will open its doors to the public on Sunday 16 June 2024 from 13:30 to 18:00. Full information is available on the dedicated EDQM Open Day web page. Join us for a fun-packed afternoon to discover how the EDQM contributes to...

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European Paediatric Formulary: Amiodarone hydrochloride capsules (5 mg-200 mg) monograph in public consultation

EDQM 11/06/2024 Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just released Issue 9 of Pharmeuropa PaedForm, containing the 11th monograph of the PaedF Working Party, Amiodarone hydrochloride capsules (5 mg-200 mg) for public consultation. The deadline for comments is 30 September...

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Certification monthly report of activities: End of May 2024

EDQM 10/06/2024 Strasbourg, France

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

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Pharmacopoeial Discussion Group achievements

EDQM 07/06/2024 Strasbourg, France

The Pharmacopoeial Discussion Group (PDG) held its interim videoconference on 15 April 2024. The primary topic of the meeting was the lessons learned from the PDG expansion pilot programme that was launched in 2022 and ended in October 2023 with the inclusion of the Indian Pharmacopoeia...

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5 new Ph. Eur. reference standard and 13 replacement batches released in May 2024

EDQM 04/06/2024 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...

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EDQM upgrades CombiStats to web version

EDQM 04/06/2024 Strasbourg, France

CombiStats is getting an upgrade. The new version of this powerful statistical analysis tool for data from biological dilution assays or potency assays, maintained by the European Directorate for the Quality of Medicines & HealthCare (EDQM), will be launched as a web application on 4 July 2024....

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30th anniversary of the OMCL Network – Celebrating the success of international collaboration for safe medicines at the 29th GEON meeting

EDQM 04/06/2024 Strasbourg, France

The 29th Annual Meeting of the General European Official Medicines Control Laboratories Network (GEON) was held from 13 to 17 May 2024 in Ohrid (North Macedonia). Over 230 participants representing 63 official medicines control laboratories (OMCLs) from 38 countries attended this meeting, which...

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Save the date – Get ready to join our webinar on 12 November 2024

EDQM 30/05/2024 Strasbourg, France

BINACLE Assay for Tetanus Neurotoxin: Outcomes of Collaborative Study BSP136 The testing procedure in the European Pharmacopoeia (Ph. Eur.) for demonstrating the absence of tetanus toxin from toxoids used in the manufacture of both human and veterinary vaccines currently consists of an in vivo...

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EDQM reports presence of banned substances in skin whitening products

EDQM 22/05/2024 Strasbourg, France

The European Network of Official Cosmetics Control Laboratories (OCCLs) recently conducted a surveillance study on skin whitening products available on the European market. Their analysis found that 18% of the products tested were non-compliant due to the presence of hydroquinone, mercury and/or...

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NEW 4th Training Course on Quality Management for Tissue Establishments

EDQM 21/05/2024 Strasbourg, France

A robust quality management system (QMS) is key to ensuring the efficacy, quality and safety of tissues and cells for human application. Tissue establishments (TEs) need to implement a QMS to ensure that tissues and cells for human application comply with the applicable technical and legal...

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Draft guideline on ‘Content of the dossier for sterile substances’ released for public consultation

EDQM 17/05/2024 Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has drafted a guideline ‘Content of the dossier for sterile substances’ (PA/PH/CEP (23) 54). The draft document is now available for public consultation in the consultation space. The consultation deadline for this document...

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European Pharmacopoeia Supplements 11.6 to 11.8 – 2025 subscriptions now open!

EDQM 17/05/2024 Strasbourg, France

The 2025 subscriptions to the European Pharmacopoeia (Ph. Eur.), including the Supplements 11.6 to 11.8, are now available for purchase in the WebStore of the European Directorate for the Quality of Medicines & HealthCare (EDQM). Two subscription formats are available. Both include access to all...

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Cosmetics – Joint meeting of OCCL Network and CD-P-COS

EDQM 16/05/2024 Strasbourg, France

The 13th meeting of the Network of Official Cosmetics Control Laboratories (OCCLs) was held in Strasbourg on 19 and 20 March 2024. This joint session brought together network members and experts from the European Committee for Cosmetics and Consumer Health (CD-P-COS). Participants from 26...

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Public consultation on new general texts on mRNA vaccines in Pharmeuropa 36.2

EDQM 14/05/2024 Strasbourg, France

The European Pharmacopoeia (Ph. Eur.) is seeking stakeholder feedback on a series of three new general texts on mRNA vaccines, published in this quarter’s issue of Pharmeuropa 36.2 for comment. The mRNA vaccine field has developed rapidly in the past few years and continues to evolve into an...

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Public consultation on new general chapter on High-throughput sequencing for the detection of viral extraneous agents in Pharmeuropa 36.2

EDQM 07/05/2024 Strasbourg, France

The European Pharmacopoeia (Ph. Eur.) is seeking stakeholder feedback on its new general chapter, HTS for the detection of viral extraneous agents (2.6.41), published in this quarter’s issue of Pharmeuropa (36.2) for comment. High-Throughput Sequencing (HTS, also known as Next-Generation...

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Specialist - Nuclear magnetic resonance (NMR)

EDQM Deadline for applications: 27/05/2024 Strasbourg, France

Grade: A1/2 Salary: from €5 536 to €7 074 per month (gross) Location: Strasbourg (France) Reference: Vacancy Notice n° e25/2024 Deadline for applications: 27/05/2024 Apply here Do you have practical/hands-on laboratory experience of nuclear magnetic...

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Certification monthly report of activities: End of April 2024

EDQM 06/05/2024 Strasbourg, France

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

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Public consultation on Traceability of Medicines in Hospital Settings

EDQM 19/04/2024 Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare is seeking comments from interested parties on a draft guidance document on the topic of “Traceability of Medicines in Hospital Settings”. The objective of this project is to provide regulatory authorities and stakeholders with a...

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Don’t miss your chance to comment: HPTLC fingerprinting in two monographs on homoeopathic preparations

EDQM 29/04/2024 Strasbourg, France

The first two monographs, Calendula for homoeopathic preparations (2492) and Chamomilla for homoeopathic preparations (2493), resulting from the pilot study on the use of semi-quantitative high-performance thin-layer chromatography (HPTLC) fingerprinting for homoeopathic preparations containing...

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5 new Ph. Eur. reference standard and 20 replacement batches released in April 2024

EDQM 02/05/2024 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...

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Public consultation on a new general chapter on cell-based preparations for human use in Pharmeuropa 36.2

EDQM 29/04/2024 Strasbourg, France

In response to the need for a text covering the quality of cell-based preparations in the rapidly evolving field of advanced therapy medicinal products, the European Pharmacopoeia Commission is proposing a new general chapter, Cell-based preparations for human use (5.32), to its stakeholders. The...

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New European Pharmacopoeia Commission approach to gene therapy

EDQM 29/04/2024 Strasbourg, France

General chapter 5.14. Gene transfer medicinal products for human use was first published in European Pharmacopoeia (Ph. Eur.) Supplement 5.6 in 2006, when there were no approved gene therapy medicinal products (GTMPs) on the European market. Several GTMPs have since been approved and an...

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EDQM call for tender – Elemental analysis (C, H, N, O, S)

EDQM 26/04/2024 Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has launched a tender to select a service provider for elemental analysis (C, H, N, O, S) of various chemical compounds based on the needs of the organisation. Interested laboratories can submit their offers by 29 July 2024...

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Publication of BSP study outcome on measuring procoagulant activity in human normal immunoglobulin available online

EDQM 24/04/2024 Strasbourg, France

The outcome of a successful study on the determination of procoagulant activity in human normal immunoglobulin preparations for therapeutic use by FXIa chromogenic assay has recently been published in the EDQM online journal Pharmeuropa Bio & Scientific Notes. The article details the methods...

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Shortage of aprepitant, powder for oral suspension – Expert opinion of the EDSForm Working Party

EDQM 23/04/2024 Strasbourg, France

Aprepitant is a NK1 receptor antagonist that is mainly used in the prevention of chemotherapy-induced or postoperative nausea and vomiting. The only licensed medicinal product containing aprepitant that is appropriate for paediatric patients – a powder for oral suspension (Emend 125 mg powder for...

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Critical medicine shortages - immediate workflow and trial phase with two ongoing shortages

EDQM 19/04/2024 Strasbourg, France

The task of the European Drug Shortages Formulary Working Party (EDSForm WP), created at the end of November 2023, is to define both short-term and long-term actions aimed at mitigating the negative impact of medicine shortages on public health. Short-term actions involve compiling technical...

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Immunoglobulin (anti-A, anti-B antibodies test Negative control) BRP (cat. # Y0001689)

EDQM 18/04/2024 Strasbourg, France

Further to the premature depletion of stocks of the Immunoglobulin (anti-A, anti-B antibodies test Negative control) BRP (cat. # Y0001689), we wish to inform users that the distribution quota has been revised. This BRP will be distributed to plasma-derived therapeutic product manufacturers and...

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Deadline extended to 30 April: survey on strategy for Ph. Eur. quality standards for monoclonal antibodies

EDQM 12/04/2024 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...

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European Pharmacopoeia to put an end to all animal tests for histamine and depressor substances

EDQM 10/04/2024 Strasbourg, France

At its 177th session in November 2023, the European Pharmacopoeia Commission (EPC) decided to engage on a path that should ultimately lead to the deletion of the general chapters on Histamine (2.6.10) and Depressor substances (2.6.11) from the European Pharmacopoeia (Ph. Eur.). Both chapters...

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New general chapter on Phage therapy medicinal products (5.31) adopted and pre-published on the EDQM website

EDQM 10/04/2024 Strasbourg, France

Rising levels of antimicrobial resistance in recent years, identified as one of the leading threats to global public health and development, have prompted renewed interest in the use of phage therapy for the treatment of bacterial infections. This led the European Pharmacopoeia Commission (EPC)...

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JP and Ph. Eur. launch a bilateral prospective harmonisation project for active substance and medicinal product monographs

EDQM 09/04/2024 Strasbourg, France

The Japanese Pharmacopoeia (JP) and the European Pharmacopoeia (Ph. Eur.) are pleased to announce the launch of a bilateral prospective harmonisation project targeting pharmacopoeial standards for active substances and medicinal products. Pharmacopeial harmonisation serves to further reduce the...

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How to identify the manufacturing sites linked to CEP application (revised document)?

EDQM 08/04/2024 Strasbourg, France

Please consult the revised policy document which has been updated to complete the identification of the manufacturing sites by the SPOR OMS coordinates. The use of these coordinates is mandatory, and companies should ensure that their organisation name and location address(es) given to the EDQM...

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CEP holders invited to comment on draft monographs published in Pharmeuropa 36.2

EDQM 08/04/2024 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 36.2. The table below lists the substances...

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Certification monthly report of activities: End of March 2024

EDQM 08/04/2024 Strasbourg, France

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

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

EDQM 06/03/2024 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...

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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

EDQM 04/04/2024 Strasbourg, France

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...

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Pharmeuropa 36.2 just released

EDQM 04/04/2024 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 36.2 is 30 June 2024. Users and interested parties are welcome to comment on these drafts. It should be...

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7 new Ph. Eur. reference standard and 17 replacement batches released in March 2024

EDQM 03/04/2024 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...

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Cannabidiol impurity J CRS now available

EDQM 02/04/2024 Strasbourg, France

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.

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Revised Regulation for the Ozone-Depleting Substances

EDQM 28/03/2024 Strasbourg, France

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...

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First OMCL analytical procedures for determination of nitrosamine drug substance-related impurities (NDSRIs) and intermediate-related contaminants published

EDQM 28/03/2024 Strasbourg, France

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...

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How CEP holders can avoid the rejection of notifications

EDQM 28/03/2024 Strasbourg, France

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...

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Stakeholder consultation – New draft technical guide on FCM compliance

EDQM 19/03/2024 Strasbourg, France

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...

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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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Certification monthly report of activities: End of February 2024

EDQM 05/03/2024 Strasbourg, France

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.

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1 new Ph. Eur. reference standard and 15 replacement batches released in February 2024

EDQM 01/03/2024 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...

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Two new monographs published in European Paediatric Formulary

EDQM 29/02/2024 Strasbourg, France

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...

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Stakeholder consultation – Draft documents to support safe and correct use of herbal food supplements

EDQM 29/02/2024 Strasbourg, France

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...

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Save the date: webinar on CEP 2.0

EDQM 26/02/2024 Strasbourg, France

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

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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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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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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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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...

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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...

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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...

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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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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...

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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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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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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)...

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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...

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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...

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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...

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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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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...

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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...

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General chapters on powder characterisation techniques modernised

EDQM 18/12/2023 Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare (EDQM) is proud to highlight the remarkable progress made in 2023 on five general chapters of the European Pharmacopoeia (Ph. Eur.) that cover procedures for powder characterisation. The three revised and two newly elaborated...

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European Pharmacopoeia Supplement 11.5 now available

EDQM 15/12/2023 Strasbourg, France

The European Pharmacopoeia (Ph. Eur.) Supplement 11.5 is now available and will be applicable in 39 European countries as of 1 July 2024. This volume is included in the 2024 subscription (11.3, 11.4 and 11.5) to the 11th Edition of the Ph. Eur. Subscriptions for print and/or electronic versions...

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Implementation of pharmaceutical care in daily practice in South-eastern Europe Health Network (SEEHN) member states

EDQM 14/12/2023 Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just published the results of a survey conducted in 2022 among states who are members of both the South-eastern Europe Health Network (SEEHN) and the Council of Europe. The main objective of this initiative was to...

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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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European Pharmacopoeia welcomes Egyptian Drug Authority as observer

EDQM 11/12/2023 Strasbourg, France

The Egyptian Drug Authority has been granted observer status to the European Pharmacopoeia Commission (EPC). This decision demonstrates the dynamism of the European Pharmacopoeia (Ph. Eur.), which now has 33 observers from around the world in addition to 39 European countries and the European...

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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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EDQM publishes market surveillance study on formaldehyde in cosmetic products

EDQM 08/12/2023 Strasbourg, France

A market surveillance study conducted by the European Network of Official Cosmetics Control Laboratories (OCCLs) has found formaldehyde in approximately 30% of the products tested. Formaldehyde is a skin sensitiser and presumed carcinogen. Its use in cosmetic products is prohibited by European...

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Outcome of the 177th session of the European Pharmacopoeia Commission, November 2023

EDQM 08/12/2023 Strasbourg, France

The European Pharmacopoeia Commission (EPC) held its 177th session on 21 and 22 November 2023. The EPC adopted 77 texts at this session, to be published in European Pharmacopoeia (Ph. Eur.) Supplement 11.6 (July 2024) and be effective as of 1 January 2025. These 77 texts included nine new...

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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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Ph. Eur. pre-publishes revised Propylene glycol monograph

EDQM 06/12/2023 Strasbourg, France

The revised monograph on Propylene glycol (0430) was adopted by the European Pharmacopoeia Commission (EPC) at its 177th session held on 21 and 22 November 2023. The monograph was revised in response to the public health risk posed by the discovery of ethylene glycol (EG) and diethylene glycol...

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OMCL confirms falsification of Ozempic® batches

EDQM 05/12/2023 Strasbourg, France

Following concerns that falsified batches of Ozempic® may have entered the market, the Official Medicines Control Laboratory (OMCL) Chemisches und Veterinäruntersuchungsamt (CVUA, Karlsruhe, Germany) and a member of the European OMCL Network, has determined by analytical testing that suspected...

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European Paediatric Formulary: Flecainide acetate oral solution and Valaciclovir oral solution monographs in public consultation

EDQM 05/12/2023 Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just released Issue 8 of Pharmeuropa PaedForm. The experts of the PaedF working party are glad to publish the ninth and tenth monographs for public consultation, Flecainide acetate 10 mg/mL oral solution and...

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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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1 new Ph. Eur. reference standard and 14 replacement batches released in November 2023

EDQM 04/12/2023 Strasbourg, France

New Ph. Eur. reference standards 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...

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2024 EDQM virtual training programme: Ph. Eur. texts related to biologicals and microbiology chapters

EDQM 29/11/2023 Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has opened registration for its 2024 virtual training programme, composed of four independent modules on European Pharmacopoeia (Ph. Eur.) texts related to biologicals and on microbiology chapters. Get full information on...

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Falsification of medical devices – Results of European survey

EDQM 28/11/2023 Strasbourg, France

The falsification of medical devices is a serious international matter of concern, but little data is available, making it difficult to assess the current state of affairs. To help bridge this gap, the Committee of Experts on Minimising Public Health Risks Posed by Falsification of Medical...

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Sourcing of suppliers of personal protective equipment

EDQM 28/11/2023 Strasbourg, France

In the context of an upcoming call for tenders, the European Directorate for the Quality of Medicines & HealthCare (EDQM, a Directorate of the Council of Europe) would like to meet prospective suppliers who offer “Supply and maintenance of personal protective equipment (PPE), in particular lab...

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Swedish Medical Products Agency hosts 12th OCCL meeting in Uppsala

EDQM 22/11/2023 Strasbourg, France

The Swedish Medical Products Agency (MPA) hosted the 12th meeting of the European Network of Official Cosmetics Control Laboratories (OCCLs) on 17 and 18 October 2023. The meeting brought together 43 participants from national authorities in 24 countries, attending both on site and online....

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Immunoglobulin (anti-A, anti-B antibodies test Negative control) BRP (cat. # Y0001689)

EDQM 17/11/2023 Strasbourg, France

Due to premature depletion of stocks of the Immunoglobulin (anti-A, anti-B antibodies test Negative control) BRP (cat. # Y0001689), we wish to inform users that a tight distribution quota has been established. This BRP will be distributed to plasma-derived therapeutic product manufacturers and...

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EDQM launches updated version of the EuroGTP II tool to ensure good tissue and cell practices for human application

EDQM 15/11/2023 Strasbourg, France

To help ensure quality and safety in the field of substances of human origin (SoHO), the European Directorate for the Quality of Medicines & HealthCare (EDQM) has been entrusted with managing the EuroGTP II tool for good tissue and cell practices. Starting on 15 November 2023, this interactive...

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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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EDQM end-of-year closure: order and shipment deadlines

EDQM 10/11/2023 Strasbourg, France

Order and shipment deadlines have been established for publications and reference standards, taking into account the closure of the European Directorate for the Quality of Medicines & HealthCare (EDQM) offices from Thursday 21 December 2023 (12 noon CET) to Tuesday 2 January 2024 (8 a.m. CET)....

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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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Next-generation sequencing for adventitious virus detection in biologics: EDQM collaborates on article published in Biologicals

EDQM 08/11/2023 Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has co-authored a report with a broad range of academics and interested parties, entitled “Report of the third conference on next-generation sequencing for adventitious virus detection in biologics for humans and animals”....

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Journal of Pharmaceutical Sciences publishes results of the OMCL fingerprint study on tadalafil API samples

EDQM 03/11/2023 Strasbourg, France

The Active Pharmaceutical Ingredient (API) Working Group of the General European OMCL Network (GEON) has conducted a market surveillance study on tadalafil, the results of which have been published in the Journal of Pharmaceutical Sciences, Vol. 112 (2023). An API fingerprint is a specific...

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3 new Ph. Eur. reference standards and 21 replacement batches released in October 2023

EDQM 02/11/2023 Strasbourg, France

New Ph. Eur. reference standards Replacement batches for Ph. Eur. reference standards 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...

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Pharmacopoeial Discussion Group Achievements

EDQM 27/10/2023 Strasbourg, France

The Pharmacopoeial Discussion Group (PDG) held its annual autumn meeting from 3 to 4 October 2023. The group welcomed the Indian Pharmacopoeia Commission (IPC) as a new member during the meeting (link). The addition of the IPC, a first in the over 34-year history of the PDG, facilitates the reach...

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OMCL Gene Therapy Working Group study published

EDQM 26/10/2023 Strasbourg, France

The outcome of a study run in the framework of the European Network of Official Medicines Control Laboratories (OMCLs) Gene Therapy Working Group (GTWG) has been published online in Pharmeuropa Bio & Scientific Notes. The article, entitled “Validation of a qPCR method for determination of viral...

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Corneal transplants – EDQM publishes new information booklet

EDQM 26/10/2023 Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just published an information booklet on corneal transplants. It explains what a corneal transplant is, who may be concerned and provides expert information on the different implantation procedures and techniques, along...

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EDQM joins efforts to tackle medicine shortages

EDQM 11/10/2023 Strasbourg, France

Medicine shortages are a growing problem that compromises patient care. Two key committees at the European Directorate for the Quality of Medicines & HealthCare (EDQM), the European Committee on Pharmaceuticals and Pharmaceutical Care (CD-P-PH) and the European Pharmacopoeia Commission (EPC), are...

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Revised general chapter 2.7.24 Flow cytometry in Pharmeuropa 35.4

EDQM 17/10/2023 Strasbourg, France

The European Pharmacopoeia (Ph. Eur.) is seeking stakeholder feedback on the revised general chapter Flow cytometry (2.7.24), published in this quarter’s issue of Pharmeuropa (35.4) for comment (public deadline 31 December 2023). The revision of this general chapter is of high importance since it...

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Newsletter Transplant 2023 – Informing the future of transplantation

EDQM 17/10/2023 Strasbourg, France

A new edition of Newsletter Transplant has just been published, presenting data on donation and transplantation activities worldwide in 2022. This year’s report covers a record 86 countries. It is produced annually thanks to the invaluable support of the Spanish Organización Nacional de...

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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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