Newsroom
EDQM On Air – Discover the vast international network working to protect your public health
The European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe works with many national and international stakeholders for the protection of public health. Tune in now to find out more about their collaboration and the real-life outcomes of their work by...
EDQM end-of-year closure: order and shipment deadlines
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 Tuesday 24 December 2024 (12 noon CET) to Tuesday 2 January 2025 (8 a.m. CET). The...
Certification monthly report of activities: End of October 2024
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of October 2024 Certification Monthly Report For more information, access the Certification Database.
EDQM On Air – Learn how the EDQM protects consumer health
Consumer health protection is an area in which the European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe has played an active role for many years. Everyday products such as cosmetics, food contact materials and tattoo inks fall under its watchful eye. By...
EDQM reference standards newsletter – October 2024
6 new Ph. Eur. reference standards and 24 replacement batches released in October 2024 The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just published its monthly report on the situation of European Pharmacopoeia reference standards. It includes information on new and...
A new era for the European Pharmacopoeia – Online-only format from June 2025
The European Directorate for the Quality of Medicines & HealthCare (EDQM) will launch the online-only European Pharmacopoeia (Ph. Eur.) in June 2025, bringing legally binding European pharmacopoeial standards to subscribers in a modern and easier-to-use format. The discontinuation of the printed...
New EDQM “Guidelines on medication review” just released
“Guidelines on medication review” has just been published by the European Directorate for the Quality of Medicines & HealthCare (EDQM). This work provides essential guidance on medication review processes that will enable healthcare professionals to conduct structured and systematic evaluations...
Scientific Assistant – Quality and Process Management
Do you have the skills and experience in quality documentation, auditing and process analysis required to play a critical role in fostering a “quality culture”?
OMCL Network welcomes Türkiye as a full member
The Analysis and Control Laboratories Department of the Turkish Medicines and Medical Devices Agency has become a full member of the General European OMCL Network (GEON), co-ordinated by the European Directorate for the Quality of Medicines & HealthCare (EDQM). It is the first Turkish official...
Newsletter Transplant 2024 – Organ donation increases globally
A new edition of Newsletter Transplant has just been published, presenting data on donation and transplantation activities worldwide in 2023. This report is produced annually thanks to the invaluable support of the Spanish Organización Nacional de Trasplantes (ONT), which co-ordinates the...
CEP Revisions Teamleader
Do you have proven experience in the evaluation or the preparation of documentation on the quality of substances for pharmaceutical use?
Removal of expiry notifications from the EDQM DCEP Sharing Tool
The EDQM DCEP Sharing Tool is used to share EDQM documents securely between the Certification of Substances Department (DCEP) and CEP holders or applicants. Users receive an e mail with a link when a document is shared with them. Links expire after 60 days, after which time the documents cannot...
Essential oils in cosmetics: EDQM publishes revised guidance with best practices for safety assessment
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published the second edition of “Guidance on essential oils in cosmetic products” to help ensure the safety of cosmetic products in line with European and national cosmetic legislative frameworks. Cosmetic products are...
Implementation of the European Pharmacopoeia Supplement 11.7 – Notification for CEP holders
Supplement 11.7 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 2025, and to follow the...
Tune in to EDQM On Air to get your dose of information on European public health
We are excited to announce the launch of EDQM On Air, the first podcast from the European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe! Tune in for expert insights, engaging discussions and inspiring stories and discover how the EDQM, together with its...
CEP holders invited to comment on draft monographs published in Pharmeuropa 36.4
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 36.4. The table below lists the substances...
Publication on the establishment study for PKA in Albumin BRP replacement batches now online
The outcome of the successful study for the establishment of the European Pharmacopoeia (Ph. Eur.) Prekallikrein Activator (PKA) in Albumin Biological Reference Preparation (BRP) batches 8, 9 and 10 has been published in Pharmeuropa Bio & Scientific Notes, the online scientific journal of the...
Pharmeuropa 36.4 just released
All new European Pharmacopoeia (Ph. Eur.) texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments on Pharmeuropa 36.4 is 31 December 2024. Users and interested parties are welcome to comment on these drafts. It should...
Certification monthly report of activities: End of September 2024
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of September 2024 Certification Monthly Report For more information, access the Certification Database.
Webinar – Advancements in gene therapy: the European Pharmacopoeia’s new approach
The European Directorate for the Quality of Medicines & HealthCare (EDQM) will hold a free webinar entitled “Advancements in gene therapy: the European Pharmacopoeia’s new approach” on 3 December 2024, from 14:00 to 16:00 (CET, Paris, France). REGISTER NOW In response to the recent approval of...
European Pharmacopoeia Supplement 11.7 now available
The European Pharmacopoeia (Ph. Eur.) Supplement 11.7 is now available and will be applicable in 39 European countries as of 1 April 2025. This volume is included in the 2025 subscription (11.6, 11.7 and 11.8) to the 11th Edition of the Ph. Eur. Subscriptions for print and/or electronic versions...
7 new Ph. Eur. reference standard and 19 replacement batches released in September 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...
Registration now open for the EDQM Blood Conference – Innovation in Blood Establishment Processes
Registration is now open for the EDQM Blood Conference – Innovation in Blood Establishment Processes, which will take place on 14 and 15 January 2025 in Strasbourg (France). Do you regularly encounter topics related to blood donation and blood component processes in your professional activities?...
European Donation Day 2024: a celebration of life and giving
Created almost 30 years ago, European Donation Day (EDD) – the European Day for Organ, Tissue and Cell Donation – is a powerful initiative aimed at raising awareness of the life-saving potential of organ, tissue and cell donation, driven by the European Directorate for the Quality of Medicines &...
Publication of two BSP studies on the BINACLE method – In vitro approach to safety testing of tetanus vaccines for human and veterinary use
Two publications on the outcomes of BSP136, a project aimed at evaluating the suitability of the Binding and Cleavage test (BINACLE) as an in vitro method for the detection of tetanus neurotoxin in the toxoids used for producing human and veterinary vaccines, have been published in the online...
Two new monographs published in European Paediatric Formulary
Two new monographs, Flecainide acetate 10 mg/mL oral solution and Valaciclovir 20 mg/mL oral solution, elaborated by the European Paediatric Formulary (PaedF) working party have been added to the European Paediatric Formulary (Formulary) after a successful public consultation phase. The Formulary...
Save the date: Webinar Everything you've always wanted to know about the certification (CEP) procedure.
The EDQM invites CEP holders and users to participate in a webinar to facilitate the understanding of the Certification Procedure on 21 November 2024. Programme overview: The EDQM invites CEP holders and users to participate in a webinar to ask any kind of questions on the Certification Procedure...
Certification monthly report of activities: End of August 2024
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of August 2024 Certification Monthly Report For more information, access the Certification Database.
4 new Ph. Eur. reference standard and 15 replacement batches released in August 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...
PDG announces global membership initiative
The Pharmacopoeial Discussion Group (PDG) is excited to announce the launch of the next phase of its global expansion initiative aimed at increasing convergence of harmonised pharmacopoeial standards. This initiative will be the start of a process over the next couple of years to welcome...
Update on BSP study on the evaluation of a replacement method for the potency control of whole cell pertussis vaccines
The Biological Standardisation Programme (BSP) wishes to inform the scientific community that the project coded BSP104 has been brought to a close. The project aimed at evaluating a replacement method for the in vivo challenge test for the potency control of whole-cell pertussis vaccines...
Article on joint WHO/EDQM establishment study for Prekallikrein activator in albumin reference standards now online
The outcome of the successful study to establish the European Pharmacopoeia (Ph. Eur.) Biological Reference Preparation (BRP) for Prekallikrein activator in albumin batch 7 has been published in the scientific journal Pharmeuropa Bio & Scientific Notes. The study (BSP153) was organised jointly by...
Certification monthly report of activities: End of July 2024
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of July 2024 Certification Monthly Report For more information, access the Certification Database.
4 new Ph. Eur. reference standard and 19 replacement batches released in July 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...
“Metals and alloys used in food contact materials and articles” – Second edition of the EDQM technical guide now available
The European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe has published the second edition of the technical guide “Metals and alloys used in food contact materials and articles”. Intended for regulators and business operators and designed to enhance the...
Publication of BSP study outcome on anti-D antibodies in IVIG reference standards available online
A new article on the outcome of the study for the establishment of replacement batches of reference standards to control the level of anti-D antibodies in human immunoglobulin products for intravenous administration has been published in the online journal Pharmeuropa Bio & Scientific Notes. The...
New monographs on an anti-interleukin monoclonal antibody released for public consultation
The European Pharmacopoeia (Ph. Eur.) has published two new draft monographs, Ustekinumab concentrated solution (3165) and Ustekinumab injection (3188), for public comment in this quarter’s issue of Pharmeuropa (36.3). Following the adoption and publication of the monographs for Etanercept...
Ph. Eur. seeks feedback on the use of plastic additive 18
Plastic additive 18 (P-EPQ, for more details see appendix ) is a phenolic antioxidant that may be used as a stabiliser in the processing of plastic materials. It consists of seven components, all of which contribute to the efficiency of the additive, but is a product-by-process (reaction product)...
Publication of outcome of study for Human Immunoglobulin (molecular size) BRP replacement batches
The outcome of the recently completed Biological Standardisation Programme study for the establishment of Human immunoglobulin (molecular size) Biological Reference Preparation (BRP) replacement batches 4, 5 and 6, has been published in the online journal Pharmeuropa Bio & Scientific Notes. The...
Call for experts – Join the Bovine Serum Working Party!
Bovine serum is widely used in the manufacture of human and veterinary medicinal products, for example as a supplement in cell culture media for the production of vaccines (both human and veterinary) and advanced therapy medicinal products (ATMPs). The European Pharmacopoeia (Ph. Eur.) monograph...
Making a significant difference – 2023 EDQM annual report published in new engaging digital format
The European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe has published its 2023 annual report. For the first time, the report is completely digital, with a new, intuitive design and interactive features, facilitating your discovery journey and making it...
Shortage of amoxicillin paediatric products: expert opinion of the European Drug Shortages Formulary Working Party
Amoxicillin is an aminopenicillin used to treat a number of infections. In recent years (particularly during the winter months), several member states have reported major difficulties in procuring amoxicillin-containing products, with paediatric forms of the antibiotic especially affected. In...
CEP holders invited to comment on draft monographs published in Pharmeuropa 36.3
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 36.3. The table below lists the substances...
Certification monthly report of activities: End of June 2024
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of June 2024 Certification Monthly Report For more information, access the Certification Database.
Ph. Eur. bids adieu to rabbit pyrogen test in its monographs
Pyrogen detection is essential for ensuring the safety of parenteral medicines. For decades, the rabbit pyrogen test (RPT) has been the traditional method. The RPT involves measuring the rise in body temperature in rabbits following intravenous injection of the substance to be examined. Despite...
Three revised texts related to pharmaceutical waters published in Pharmeuropa 36.3
The European Pharmacopoeia (Ph. Eur.) is seeking stakeholder feedback on the following revised texts, published in this quarter’s issue of Pharmeuropa (36.3) for comment: Water for injections (0169) Purified water (0008) Total organic carbon in water for pharmaceutical use (2.2.44) The main focus...
Improved CombiStats online application now available
The CombiStats online application is available as of 4 July 2024, with an improved interface, a new licensing system and a dedicated user workspace. Users are invited to start using the online application, by creating an account and following the registration steps. The contact person who placed...
Council of Europe adopts recommendation on reporting of disappearances of medicines
In the past decade, Europe has seen a number of major pan-European cases where medicines have disappeared from the legal supply chain, and then been manipulated or tampered with before being reintroduced into it. This clearly presents a risk for public health. Follow-up enquiries and discussions...
Pharmeuropa 36.3 just released
All new European Pharmacopoeia (Ph. Eur.) texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments on Pharmeuropa 36.3 is 30 September 2024. Users and interested parties are welcome to comment on these drafts. It...
Outcome of the 179th session of the European Pharmacopoeia Commission, June 2024
The European Pharmacopoeia Commission (EPC) held its 179th session on 18 and 19 June 2024. A summary of its outcome is available in the infographic below. Highlights will be published shortly on our website and the full list of adopted texts will be made available on the Ph. Eur. Work Programme...
8 new Ph. Eur. reference standard and 18 replacement batches released in June 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...
Implementation of the European Pharmacopoeia Supplement 11.6 – Notification for CEP holders
Supplement 11.6 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 2025, and to follow the...
European Pharmacopoeia Supplement 11.6 now available
The European Pharmacopoeia (Ph. Eur.) Supplement 11.6 is now available and will be applicable in 39 European countries as of 1 January 2025. This volume is included in the 2025 subscription (11.6, 11.7 and 11.8) to the 11th Edition of the Ph. Eur. Subscriptions for print and/or electronic...
New general chapter on Extractable elements in plastic materials for pharmaceutical use (2.4.35) adopted
With the implementation of the ICH Q3D guideline on elemental impurities, the control of elemental impurities has undergone a shift in paradigm, moving away from pure substance-based testing towards a holistic control strategy at the medicinal product level. Parts of the Introduction and Scope of...
Call for abstracts for the EDQM Blood Conference – Innovation in Blood Establishment Processes
The EDQM Blood Conference entitled “Innovation in Blood Establishment Processes” will take place in Strasbourg, France, on 14 and 15 January 2025. Do you deal with topics related to blood donation and blood component processes in your professional activity? Why not take an active part in...
European Paediatric Formulary: Amiodarone hydrochloride capsules (5 mg-200 mg) monograph in public consultation
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...
Certification monthly report of activities: End of May 2024
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.
Pharmacopoeial Discussion Group achievements
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...
5 new Ph. Eur. reference standard and 13 replacement batches released in May 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...
EDQM upgrades CombiStats to web version
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....
30th anniversary of the OMCL Network – Celebrating the success of international collaboration for safe medicines at the 29th GEON meeting
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...
Save the date – Get ready to join our webinar on 12 November 2024
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...
EDQM reports presence of banned substances in skin whitening products
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...
NEW 4th Training Course on Quality Management for Tissue Establishments
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...
European Pharmacopoeia Supplements 11.6 to 11.8 – 2025 subscriptions now open!
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...
Cosmetics – Joint meeting of OCCL Network and CD-P-COS
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...
Public consultation on new general texts on mRNA vaccines in Pharmeuropa 36.2
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...
Public consultation on new general chapter on High-throughput sequencing for the detection of viral extraneous agents in Pharmeuropa 36.2
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...
Public consultation on Traceability of Medicines in Hospital Settings
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...
Certification monthly report of activities: End of April 2024
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.
5 new Ph. Eur. reference standard and 20 replacement batches released in April 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...
Don’t miss your chance to comment: HPTLC fingerprinting in two monographs on homoeopathic preparations
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...
Public consultation on a new general chapter on cell-based preparations for human use in Pharmeuropa 36.2
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...
New European Pharmacopoeia Commission approach to gene therapy
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...
Publication of BSP study outcome on measuring procoagulant activity in human normal immunoglobulin available online
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...
Shortage of aprepitant, powder for oral suspension – Expert opinion of the EDSForm Working Party
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...
Critical medicine shortages - immediate workflow and trial phase with two ongoing shortages
Download 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...
Immunoglobulin (anti-A, anti-B antibodies test Negative control) BRP (cat. # Y0001689)
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...
Deadline extended to 30 April: survey on strategy for Ph. Eur. quality standards for monoclonal antibodies
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...
European Pharmacopoeia to put an end to all animal tests for histamine and depressor substances
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...
New general chapter on Phage therapy medicinal products (5.31) adopted and pre-published on the EDQM website
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)...
JP and Ph. Eur. launch a bilateral prospective harmonisation project for active substance and medicinal product monographs
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...
How to identify the manufacturing sites linked to CEP application (revised document)?
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...
CEP holders invited to comment on draft monographs published in Pharmeuropa 36.2
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...
Certification monthly report of activities: End of March 2024
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.
Pharmeuropa 36.2 just released
All new European Pharmacopoeia (Ph. Eur.) texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments on Pharmeuropa 36.2 is 30 June 2024. Users and interested parties are welcome to comment on these drafts. It should be...
As a CEP applicant, you want to improve the quality of your dossier? The revised EDQM guideline “content of the dossier” and other key documents will be useful tools
The revised version of the EDQM guideline “Content of the dossier for chemical purity and microbiological quality of substances for pharmaceutical use” is now available and will be implemented as of 1 May 2024. This guideline and other key documents (QOS, top ten deficiencies), as well as the use...
Survey on strategy for Ph. Eur. quality standards for monoclonal antibodies
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...
7 new Ph. Eur. reference standard and 17 replacement batches released in March 2024
New Ph. Eur. reference standards and Replacement batches for Ph. Eur. reference standards Distribution quota Removal Future removal Change of sales units Information on change of amount per unit Information on change of price Change of EDQM storage/shipping conditions Information on International...
Cannabidiol impurity J CRS now available
The standard cannabidiol impurity J CRS that is described in the monograph on Cannabidiol (3151) is now available for users under catalogue code Y0002436. More information on how to order is available on the EDQM website.
Revised Regulation for the Ozone-Depleting Substances
Regulation (EU) 2024/590 on substances that deplete the ozone layer entered into force on 11 March 2024. The rules governing the placing on the market and use of ozone-depleting substances (ODSs) for essential laboratory and analytical uses have now changed. Under the new regulation, standards...
First OMCL analytical procedures for determination of nitrosamine drug substance-related impurities (NDSRIs) and intermediate-related contaminants published
The official medicines control laboratories (OMCLs) of the General European OMCL Network (GEON) began developing procedures for the determination of N-nitrosamine contaminants in 2018. The resulting procedures have been published for information on the website of the European Directorate for the...
How CEP holders can avoid the rejection of notifications
In order to facilitate the acceptance of proposed changes in a timely manner, CEP holders are reminded that the European Directorate for the Quality of Medicines & HealthCare (EDQM) Guideline on requirements for revision/renewal of Certificates of Suitability to the European Pharmacopoeia...
Stakeholder consultation – New draft technical guide on FCM compliance
Stakeholder consultation – New draft technical guide on FCM compliance A new draft technical guide on documentation supporting compliance and safety of food contact materials and articles is now open for comment. The European Directorate for the Quality of Medicines & HealthCare (EDQM) invites...
The template of Quality Overall Summary (QOS) to be submitted for Certification applications has been adapted to the current needs!
A new version of the QOS template is now available. It may be used from January 2024 and will become mandatory as of April 2024. The QOS (eCTD Module 2) has to be provided along with an initial submission since it is essential in the review of a new CEP application. This updated template gives...
Certification monthly report of activities: End of February 2024
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of February 2024 Certification Monthly Report For more information, access the Certification Database.
1 new Ph. Eur. reference standard and 15 replacement batches released in February 2024
New Ph. Eur. reference standards and Replacement batches for Ph. Eur. reference standards Distribution quota Removal Future removal Change of sales units Information on change of amount per unit Information on change of price Change of EDQM storage/shipping conditions Information on International...
Two new monographs published in European Paediatric Formulary
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has added two new monographs Clonidine hydrochloride 10 µg/mL oral solution and Furosemide 2 mg/mL oral solution, to the European Paediatric Formulary after a successful public consultation phase. The Formulary now...
Find information on the EDQM's responses to N-nitrosamine contamination and the COVID-19 pandemic.