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

EDQM 01/03/2024

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...

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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of Medicines & HealthCare (EDQM) is undertaking a targeted consultation to seek the opinions of interested parties on a draft guidance document for healthcare professionals and a draft leaflet for patients/consumers...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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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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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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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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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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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...

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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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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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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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European Donation Day 2023 – Your present is their future

EDQM 04/10/2023 Strasbourg, France

Organ transplantation and the human application of tissues and cells save more and more lives every year and help thousands of patients recover vital functions and lead better lives. But the number of people in need of transplantable organs, tissues and cells continues to grow at an even greater...

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Ph. Eur. pre-publishes Cannabis flower monograph on the EDQM website

EDQM 04/10/2023 Strasbourg, France

The new monograph on Cannabis flower (3028) was adopted at the 176th session of the European Pharmacopoeia (Ph. Eur.) Commission held on 20 and 21 June 2023. Given the exceptionally high interest from stakeholders in having access to the new text as soon as possible, the Ph. Eur. decided to make...

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European Paediatric Formulary: Chloral hydrate oral solution monograph published

EDQM 04/10/2023 Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published its fifth new monograph, Chloral hydrate 100 mg/mL oral solution, in the European Paediatric Formulary. The monograph was published for public consultation in Issue 5 of Pharmeuropa PaedForm in January 2023,...

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Pharmeuropa 35.4 just released

EDQM 04/10/2023 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 35.4 is 31 December 2023. Users and interested parties are welcome to comment on these drafts. It should...

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European Pharmacopoeia Supplement 11.4 now available

EDQM 03/10/2023 Strasbourg, France

The European Pharmacopoeia (Ph. Eur.) Supplement 11.4 is now available and will be applicable in 39 European countries as of 1 April 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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17 replacement batches released in September 2023

EDQM 02/10/2023 Strasbourg, France

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 Substances (ICRS) and International...

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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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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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Optimising pharmacotherapy and improving patient outcomes: EDQM collaborates on article published in Frontiers in Pharmacology

EDQM 19/09/2023 Strabourg, France

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has co-authored an article with a broad range of academics and interested parties, entitled “Recommendations for wider adoption of clinical pharmacy in Central and Eastern Europe in order to optimise pharmacotherapy and...

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Safe cosmetics for young children – Second edition provides state-of-the-art guidance on cosmetic products for infants and young children

EDQM 18/09/2023 Strasbourg, France

Soda or shampoo? Candy or soap? Young children can easily mistake certain cosmetics or even their packaging for foodstuff based on their perfume, appearance, form, colour or size. Ingesting the chemicals contained in such products is dangerous and small parts can easily be swallowed and may cause...

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Ph. Eur. allows the use of recombinant factor C for control of bacterial endotoxins in water monographs

EDQM 13/092023 Strasbourg, France

Revised versions of the widely used monographs, Water for injections (0169) and Purified water (0008), will be published in Supplement 11.4 of the European Pharmacopoeia (Ph. Eur.). Adopted by the Ph. Eur. Commission at its 175th session in March this year, these two fundamental texts now allow...

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Validating analytical procedures for determining nitrosamines in pharmaceuticals: European OMCLs participate in collaborative study with international regulatory agencies

EDQM 08/09/2023 Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare (EDQM) and representatives of official medicines control laboratories (OMCLs) in Europe, as well as the US Food and Drug Administration, Health Canada and the Therapeutic Goods Administration, Australia, have co-authored an...

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2 new Ph. Eur. reference standards and 16 replacement batches released in August 2023

EDQM 08/09/2023 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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CEP 2.0: Changes from September 2023 to information published in Certification Online and Knowledge databases

EDQM 07/09/2023 Strasbourg, France

The launch of CEP 2.0 will bring changes, beginning in September, to the information on CEPs published on the Certification Online and Knowledge databases. The tabulated data will now include additional columns showing SPOR ORG and LOC-ID information for the holder where this is available,* as...

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Certification monthly report of activities: End of August 2023

EDQM 06/09/2023 Strasbourg, France

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

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Elemental impurity chemical reference standards (CRS) available in the EDQM reference standards catalogue

EDQM 08/08/2023 Strasbourg, France

Lead solution CRS, Cadmium solution CRS, Mercury solution CRS, Arsenic solution CRS, Nickel solution CRS, Palladium solution CRS and, most recently, Platinum solution CRS are now available in the EDQM RS portfolio. For medicinal products, elemental impurities must be evaluated during risk...

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Certification monthly report of activities: End of July 2023

EDQM 07/08/2023 Strasbourg, France

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

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2 new Ph. Eur. reference standards and 18 replacement batches released in July 2023

EDQM 01/08/2023 Strasbourg, France

New Ph. Eur. reference standards Replacement batches for Ph. Eur. reference standards Information on reference standards removed from catalogue Information on reference standards with a future removal from catalogue Information on change of sales units Information on change of amount per unit...

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N-nitrosamine impurities in Ph. Eur. monographs: update on approach

EDQM 24/07/2023 Strasbourg, France

Over the past few years, the texts of the European Pharmacopoeia (Ph. Eur.) have been adapted regularly to reflect the latest European regulatory requirements for N-nitrosamines. This included adding a Production statement covering the risk of N-nitrosamine formation to the Ph. Eur.’s five...

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CEP 2.0: The CEP letter of access is ready for use!

EDQM 24/07/2023 Strasbourg, France

The replacement of the declaration of access box on the CEP document by a separate letter of access is one of the changes introduced with the implementation of the CEP 2.0. The template for this letter is now finalised taking into account comments received during the public consultation. The CEP...

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Important update on N-nitrosamine impurities in substances covered by CEPs

EDQM 21/07/2023 Strasbourg, France

On 7 July 2023, the EMA published a revised version of the “Questions and answers for marketing authorisation holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products”. This update includes new...

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CEP 2.0: implementation date

EDQM 19/07/2023 Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare (EDQM) is pleased to announce that the CEP 2.0 will be implemented on 1 September 2023. From that date onwards, new dossier applications and renewal applications will receive a CEP 2.0, whereas revision applications will receive a...

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Implementation of the European Pharmacopoeia Supplement 11.3 – Notification for CEP holders

EDQM 17/07/2023 Strasbourg, France

Supplement 11.3 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 2024, and to follow the...

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CEP holders invited to comment on draft monographs published in Pharmeuropa 35.3

EDQM 17/07/2023 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 35.3. The table below lists the substances...

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EDQM Director elected Chair of IPRP Management Committee

EDQM 07/07/2023 Strasbourg, France

The International Pharmaceutical Regulators Programme (IPRP) held its 11th Management Committee (MC) meeting in Vancouver (Canada) on 13 and 14 June 2023. The European Directorate for the Quality of Medicines & HealthCare (EDQM), an observer to the IPRP, participated in this meeting. The IPRP...

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Certification monthly report of activities: End of June 2023

EDQM 07/07/2023 Strasbourg, France

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

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Outcome of the 176th session of the European Pharmacopoeia Commission, June 2023

EDQM 05/07/2023 Strasbourg, France

The European Pharmacopoeia Commission (EPC) held its 176th session on 20 and 21 June 2023. The 67 texts adopted at this session by the EPC will be published in European Pharmacopoeia (Ph. Eur.) Supplement 11.5 (January 2024), with an implementation date of 1 July 2024. These 67 texts included 11...

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2022 Highlights – EDQM annual report now available

EDQM 05/06/2023 Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published its 2022 annual report, providing a comprehensive overview of its activities and achievements, and putting select data on the present state of EDQM/Council of Europe public health initiatives at your...

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Pharmeuropa 35.3 just released

EDQM 03/07/2023 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 35.3 is 30 September 2023.

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4 new Ph. Eur. reference standards and 10 replacement batches released in June 2023

EDQM 03/07/2023 Strasbourg, France

New Ph. Eur. reference standards Replacement batches for Ph. Eur. reference standards Information on reference standards removed from catalogue Information on reference standards with a future removal from catalogue Information on change of sales units Information on change of amount per unit...

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New Pharmeuropa Bio & Scientific Notes article now online: HCV RNA for NAT BRP replacement batch

EDQM 03/07/2023 Strasbourg, France

Following the successful completion of the Biological Standardisation Programme (BSP) study for the establishment of batch 2 of the Hepatitis C Virus (HCV) RNA for nucleic acid amplification techniques (NAT) Biological Reference Preparation (BRP), the outcome has been published in the online...

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European Pharmacopoeia Supplement 11.3 now available

EDQM 01/07/2023 Strasbourg, France

The European Pharmacopoeia (Ph. Eur.) Supplement 11.3 is now available and will be applicable in 39 European countries as of 1 January 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...

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Over 100 excipient monographs now with an FRC section in the Ph. Eur.

EDQM 30/06/2023 Strasbourg, France

European Pharmacopoeia (Ph. Eur.) Supplement 11.2, which comes into force in 39 European countries on 1 July 2023, contains five excipient monographs that have been revised to include a section on functionality-related characteristics (FRCs), boosting the total of Ph. Eur. monographs that include...

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New Pharmeuropa Bio & Scientific Notes article now online: Assay discrepancies using human coagulation factor VIII chromogenic kits

EDQM 30/06/2023 Strasbourg, France

The outcome of a study to investigate reported assay discrepancies using human coagulation factor VIII chromogenic kits has been published in the online journal Pharmeuropa Bio & Scientific Notes. The study confirmed a significant discrepancy between the commercial chromogenic kits on the market...

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European Paediatric Formulary: Furosemide oral solution monograph published for public consultation in Pharmeuropa PaedForm

EDQM 29/06/2023 Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just released issue 7 of Pharmeuropa PaedForm, in which the draft text for Furosemide 2 mg/mL Oral Solution is published for public consultation with a view to its later inclusion in the European Paediatric Formulary....

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28th GEON annual meeting: another successful OMCL event

EDQM 19/06/2023 Strasbourg, France

The 28th annual meeting of the General European OMCL Network (GEON) was held in Madrid (Spain) from 5 to 9 June 2023 and brought together about 350 participants – on-site and online – from all over Europe and beyond. The four key strategic goals of the Network, which are pivotal for the future...

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Revised Policy document PA/PH/CEP (04) 1, 7R on Content of the CEP dossier released for public consultation

EDQM 19/06/2023 Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare (EDQM) is revising the policy document PA/PH/CEP (04) 1, 6R ‘Content of the dossier for CEP applications for chemical purity and microbiological quality of substances for pharmaceutical use’. The draft document for public...

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CEP 2.0: List of authorities and organisations which have access to assessment and/or inspection reports.

EDQM 19/06/2023 Strasbourg, France

In line with previous communication on CEP 2.0 related to the Authorities database and the updated Holder’s Commitment, the EDQM has now published the list of authorities and organisations with which the EDQM has a Memorandum of Understanding and/or Confidentiality Agreement in place allowing...

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EDQM publishes 2nd edition of Herbal Guide

EDQM 07/06/2023 Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just published a new edition of the Guide for the elaboration of monographs on herbal drugs and herbal drug preparations. This guide is invaluable for the authors of monographs on these substances, and also helps users...

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Certification monthly report of activities: End of May 2023

EDQM 05/06/2023 Strasbourg, France

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

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