Newsroom
EPC adopts three revised texts related to pharmaceutical waters – a major step towards global quality standards for sterilised water for injections
The European Pharmacopoeia Commission (EPC) adopted three revised texts related to pharmaceutical waters during its 182nd session in June 2025. This constitutes a significant step forward in converging quality standards for the most widely used excipients in the pharmaceutical industry. The...
Public consultation on a new general chapter 2.6.42. Test for procoagulant activity in immunoglobulin preparations in Pharmeuropa 37.3
The European Pharmacopoeia (Ph. Eur.) has published a draft of a new general chapter, 2.6.42. Test for procoagulant activity in immunoglobulin preparations, for public consultation in the current issue of Pharmeuropa (37.3). Stakeholders are invited to submit their comments by the end of...
Public consultation on a new general chapter 2.5.46. Phenolic antioxidants in plastic materials in Pharmeuropa 37.3
After several years of dedicated work by the experts of Group 16 (Plastic materials, plastic containers and closures), a new HPLC-UV analytical procedure has been developed to test for phenolic antioxidants in plastic materials and is described in the new general chapter 2.5.46. Phenolic...
Gradual rollout of a new primary label for European Pharmacopoeia reference standards
We would like to inform you that the EDQM will gradually introduce a new primary label for European Pharmacopoeia reference standards. This introduction will take place in several stages and will affect new reference standards (batch 1) placed on the market from the end of July 2025 onwards. It...
Ph. Eur. publishes revised general chapter 3.2.1. Glass containers for pharmaceutical use in Pharmeuropa 37.3
Thanks to the efforts and dedication of the experts of the Glass (GLS) Working Party, general chapter 3.2.1 has undergone its first significant revision since 2019, when it was published in European Pharmacopoeia (Ph. Eur.) Supplement 9.6. The primary aim of this revision is to clarify the...
Ph. Eur. NANO Working Party reaches significant milestone publication of its first monograph, Iron Sucrose concentrated solution, in Pharmeuropa
The European Pharmacopoeia (Ph. Eur.) Nanomedicines Working Party (NANO WP) has published its first monograph, Iron Sucrose concentrated solution (2753), for public consultation. This is a major step forward for the group established in 2023 after the European Pharmacopoeia Commission agreed to...
European Paediatric Formulary: Lorazepam 1 mg/mL oral solution monograph in public consultation
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just released Issue 11 of Pharmeuropa PaedForm, containing the 12th monograph of the PaedF Working Party, Lorazepam 1 mg/mL oral solution, for public consultation. The deadline for comments is 30 September 2025....
EPC successfully concludes pilot phase on monoclonal antibodies, setting the stage for future standardisation in this field
The European Pharmacopoeia Commission (EPC) formally endorsed the conclusion of the pilot phase on monoclonal antibodies (mAbs) during its 182nd session, marking a major milestone in the development of public standards for these complex biotherapeutics. Launched in 2014, the pilot phase aimed to...
Pharmacopeial Discussion Group announces outcome of 2025 expansion round
The Pharmacopeial Discussion Group (PDG) is pleased to share the outcome of its latest expansion round. The initial expansion phase launched in 2022 led, after a successful pilot phase, to the inclusion of the Indian Pharmacopoeia Commission as the first new member of the PDG in 2023. Building on...
Egypt joins EDQM’s OMCL Network as an associated member
The BIO INN Laboratories of the Egyptian Drug Authority (EDA) have joined the General European OMCL Network (GEON), co-ordinated by the European Directorate for the Quality of Medicines & HealthCare (EDQM), as an associated member. After Morocco, it is the second African official medicines...
Certification monthly report of activities: End of June 2025
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of June 2025 Certification Monthly Report For more information, access the Certification Database.
CEP holders invited to comment on draft monographs published in Pharmeuropa 37.3
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 37.3. The table below lists the substances...
Tips to improve the quality of your dossier and get a CEP faster
As an applicant using the Certification of suitability to the monographs of the European Pharmacopoeia (CEP) procedure, you play a central role in ensuring the smooth processing of your request. One of the best ways to accelerate the process is by improving the quality of your submission....
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182nd session of the European Pharmacopoeia Commission: handover to a new Chair, newly elected Presidium and launch of the all-digital 12th Edition
The European Pharmacopoeia Commission (EPC) held its 182nd session on 17 and 18 June 2025. 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 European Pharmacopoeia...
Pharmeuropa 37.3 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 37.3 is 30 September 2025. Users and interested parties are welcome to comment on these drafts. It...
EDQM reference standards monthly newsletter – June 2025
1 new European Pharmacopoeia reference standard and 14 replacement batches released in June 2025 The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just published its monthly newsletter on the situation of European Pharmacopoeia reference standards. It includes...
All-digital 12th Edition marks a new era for the European Pharmacopoeia
The European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe is proud to announce the launch of the 12th Edition of the European Pharmacopoeia (Ph. Eur.). This edition – much more than just another number – ushers in a new, all-digital era for the primary...
EDQM On Air – A win for animals – Phasing out the rabbit pyrogen test
EDQM On Air, the podcast on public health brought to you by the European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe, has just released a new episode! The EDQM is committed to improving animal welfare in the context of scientific experiments and testing....
Renew your European Pharmacopoeia access
The launch of the new European Pharmacopoeia (Ph. Eur.) online platform marks the beginning of a new era for the Ph. Eur. Renew your licence today to consult the Ph. Eur. texts you need on a redesigned, user-friendly platform launched alongside the 12th Edition. In the new publication cycle, each...
EDQM reference standards monthly newsletter – May 2025
2 new European Pharmacopoeia reference standard and 15 replacement batches released in May 2025 The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just published its monthly newsletter on the situation of European Pharmacopoeia reference standards. It includes...
Certification monthly report of activities: End of May 2025
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of May 2025 Certification Monthly Report For more information, access the Certification Database.
30th GEON Annual Meeting– Highlights
The 30th Annual Meeting of the General European Official Medicines Control Laboratories Network (GEON) took place in Oslo, Norway, from 19 to 23 May 2025. Over 250 participants representing 61 official medicines control laboratories (OMCLs) from 41 countries participated, with the vast majority...
Join us at CPhI China 2025
The EDQM will be participating at CPhI China, which will take place in Shanghai at the Shanghai New International Expo Centre (SNIEC) on 24-26 June 2025. Visit our stand E1C33 to learn more about the European Pharmacopoeia, our latest publications, what new products will be coming out in the...
Launch of the 12th Edition and new online-only platform
Step into the future with us as we launch the all-digital 12th edition of the European Pharmacopoeia (Ph. Eur.), soon available exclusively on a new online platform. This significant transition marks the end of the print version and the beginning of a new era for the European Pharmacopoeia, one...
“How to read a CEP” – Revised guideline now available!
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published a revised guideline “How to read a CEP”, describing in detail the information that Certificates of suitability to the monographs of the European Pharmacopoeia (CEPs) convey. This document is intended to...
EDQM publishes 22nd edition of the Blood Guide
The European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe has published the 22nd edition of the Guide to the preparation, use and quality assurance of blood components (Blood Guide). This comprehensive guide continues to serve as an essential technical...
Modernising procedures for experts participating in EDQM activities
The success of the activities of the European Directorate for the Quality of Medicines & HealthCare (EDQM) depends on the invaluable contributions of its experts, who dedicate their time and expertise to our collective mission of achieving better health for all. To facilitate this collaboration,...
EDQM On Air – The OMCL Network – A story of collaboration for safe and good quality medicines
EDQM On Air, the podcast on public health brought to you by the European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe, has just released a new episode! We take it for granted that the medicines we take are safe and of good quality, but few know exactly how...
Pharmacopoeial Discussion Group achievements
The Pharmacopoeial Discussion Group (PDG)1 held its interim videoconference on 6 March 2025. The discussions focused on the next phase of PDG’s global membership expansion initiative. As previously announced (“PDG announces global membership initiative”), the PDG launched this initiative in...
European Pharmacopoeia Commission elects its new Chair at 181st session
The European Pharmacopoeia Commission (EPC) elected its new Chair, Dr Eugenia Cogliandro, at its 181st Session held on 25 and 26 March 2025. She will take up her duties at the 182nd Session of the EPC on 17 June 2025 for a three-year term. Dr Cogliandro has been a member of the Italian delegation...
Guide to the quality and safety of organs for transplantation – EDQM releases 9th edition
The European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe is proud to announce the release of the 9th edition of the Guide to the quality and safety of organs for transplantation (Organ Guide). This comprehensive guide remains an essential resource for...
EPC adopts mycoplasmas general chapter and monographs, updated to incorporate latest analytical developments
During its 181st session in March 2025, the European Pharmacopoeia Commission (EPC) adopted general chapter 2.6.7. Mycoplasmas and 11 monographs referring to it, all of which have been revised to reflect the new European Pharmacopoeia (Ph. Eur.) approach to the detection of mycoplasma...
Certification monthly report of activities: End of April 2025
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of April 2025 Certification Monthly Report For more information, access the Certification Database.
“Certified for success” – Register now for the CEP conference
Registrations are now open for our upcoming international conference, “Certified for success: using the CEP Procedure to elevate quality and drive trust”. Don’t miss this unique opportunity to explore the latest developments and future directions of the Certification of suitability to the...
EDQM reference standards monthly newsletter – April 2025
1 new European Pharmacopoeia reference standard and 20 replacement batches released in April 2025 The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just published its monthly newsletter on the situation of European Pharmacopoeia reference standards. It includes...
Validation of eCTD submissions for CEP applications
Compliance with EU M1 v3.1 and validation criteria v8.1 has been mandatory for all eCTD submissions since 1 March 2025. It has recently become apparent that submissions to the European Directorate for the Quality of Medicines & HealthCare (EDQM) that do not contain the now mandatory tracking...
DOIX – Simplifying DOI for EDQM experts
The European Directorate for the Quality of Medicines & HealthCare (EDQM) relies on a dedicated community of experts, whose contribution is fundamental to our collective success. To simplify, modernise and centralise procedures for experts’ mandatory declaration of interests (DOI) and...
EPC adopts cutting-edge HTS chapter to enhance viral contaminant detection in biological products
The European Pharmacopoeia Commission (EPC) adopted a new general chapter, High-throughput sequencing for the detection of viral extraneous agents (2.6.41), during its 181st session in March 2025. The new chapter will be published in Issue 12.2 of the European Pharmacopoeia (Ph. Eur.) in October...
Technical recommendation of the EDSForm WP: sulfamethoxazole-trimethoprim, paediatric products
Sulfamethoxazole-trimethoprim (also known as co-trimoxazole) is a fixed-dose combination (FDC) of two antibiotics used to treat a number of bacterial infections. Several member states have reported recurring difficulties in procuring this FDC antibiotic, with paediatric forms especially affected....
Save the date: Sterile substance CEP webinar on 4 June 2025
Due to the increasing interest in certificates of suitability for sterile substances, the EDQM would like to invite CEP holders and users to a dedicated webinar on 4 June 2025. The event will shed light on the certification procedure for sterile substances (including GMP aspects) and also provide...
Revised general chapters for elemental analysis published in Pharmeuropa 37.2
Analytical procedures for elemental analysis are described in the following European Pharmacopoeia (Ph. Eur.) general chapters: 2.2.22. Atomic emission spectrometry; 2.2.23. Atomic absorption spectrometry; 2.2.57. Inductively coupled plasma-atomic emission spectrometry; 2.2.58. Inductively...
Certification monthly report of activities: End of March 2025
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of March 2025 Certification Monthly Report For more information, access the Certification Database.
Public consultation on revised general chapter 5.1.6. Alternative methods for control of microbiological quality in Pharmeuropa 37.2
The European Pharmacopoeia (Ph. Eur.) is seeking stakeholder feedback on the revised general chapter 5.1.6. Alternative methods for control of microbiological quality, published in this quarter’s issue of Pharmeuropa 37.2 for comment. This chapter aims to facilitate the implementation of rapid...
EPC adopts groundbreaking chapter on cell-based preparations for human use
After several years of work by the Cell Therapy Products Working Party (CTP WP), the European Pharmacopoeia Commission (EPC) adopted the new general chapter Cell-based preparations for human use (5.32) during its 181st session in March 2025. The new chapter will be published in Issue 12.2 of the...
Outcome of the 181st session of the European Pharmacopoeia Commission, March 2025
The European Pharmacopoeia Commission (EPC) held its 181st session on 25 and 26 March 2025. 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 European Pharmacopoeia...
Alain Berset: “Health is our most precious gift, and a top concern for all Europeans”
Ahead of the World Health Day (7 April), Council of Europe Secretary General Alain Berset has made the following statement: “Health is our most precious gift — and a top concern for all Europeans. For the Council of Europe, health is also a fundamental human right, protected by our two main human...
EDQM reference standards monthly newsletter – March 2025
4 new European Pharmacopoeia reference standard and 12 replacement batches released in March 2025 The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just published its monthly newsletter on the situation of European Pharmacopoeia reference standards. It includes...
CEP holders invited to comment on draft monographs published in Pharmeuropa 37.2
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 37.2. The table below lists the substances...
Pharmeuropa 37.2 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 37.2 is 30 June 2025. Users and interested parties are welcome to comment on these drafts. It should be...
European Paediatric Formulary: Isoniazid 50 mg/mL oral solution monograph in public consultation
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just released Issue 10 of Pharmeuropa PaedForm, containing the 11th monograph of the PaedF Working Party, Isoniazid 50 mg/mL oral solution, for public consultation. The deadline for comments is 30 June 2025. The...
Modernising excipient monographs: revised identification techniques and new CRSs
In recent months, several revised excipient monographs and new reference standards have been added to the European Pharmacopoeia (Ph. Eur.). The aim of the changes is to support users by promoting modern IR identification techniques and replacing reference spectra with chemical reference...
EDQM On Air – The evolution of biologicals in the European Pharmacopoeia
EDQM On Air, the podcast on public health brought to you by the European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe, has just released a new episode! Biological medicinal products – or biologicals – are a class of pharmaceutical products derived or...
Save the date! International conference on the EDQM’s CEP procedure
Since 1994 , the procedure for the Certification of suitability to the monographs of the European Pharmacopoeia (CEP procedure ) has made a significant contribution to building trust in the pharmaceutical field around the world . Join us on 23-24 September 2025 in the vibrant and historic city of...
Reminder: Use of EMA SPOR/OMS ORG_ID and LOC_ID mandatory for CEP applications
As part of the implementation of the CEP 2.0, it is mandatory as of 1 June 2023 to provide, in the application forms for new dossiers, sister files and revisions and renewals, the EMA SPOR/OMS ORG_ID and LOC_ID for all companies involved in Certification of suitability (CEP) dossiers. Revised...
Certification monthly report of activities: End of February 2025
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of February 2025 Certification Monthly Report For more information, access the Certification Database.
EDQM Stakeholder Event on Plasma Supply Continuity – Programme available
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just released the programme for the upcoming stakeholder event on plasma supply continuity. Dedicated to the goal of increasing and improving plasma supply in Europe, this event will take place on 26 and 27 March 2025...
EDQM reference standards monthly newsletter – February 2025
1 new European Pharmacopoeia reference standard and 22 replacement batches released in February 2025 The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just published its monthly newsletter on the situation of European Pharmacopoeia reference standards. It includes...
EDQM On Air – AI in healthcare – Innovations, ethics and the road ahead, with Eric Sutherland
EDQM On Air, the podcast on public health brought to you by the European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe, has just released a new episode! Artificial intelligence (AI) is a source of great hope in healthcare. Properly applied, it has the...
Online publication of study for establishment of Ph. Eur. Human anti-D immunoglobulin BRP batch 2
The EDQM’s Biological Standardisation Programme, a joint programme of the Council of Europe and the European Commission, has recently run a study to establish batch 2 of the European Pharmacopoeia (Ph. Eur.) Human anti-D immunoglobulin Biological Reference Preparation (BRP). The outcome of the...
International collaboration for public health protection – EDQM welcomes African partners
The European Directorate for the Quality of Medicines & HealthCare (EDQM) recently welcomed representatives from the African Medicines Regulatory Harmonisation Secretariat, the African Medicines Quality Forum (AMQF) and the Gates Foundation to Strasbourg for a study visit. This gathering marked...
Certification monthly report of activities: End of January 2025
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of January 2025 Certification Monthly Report For more information, access the Certification Database.
Online publication on study for establishment of new Golimumab BRP
The outcome of a successful Biological Standardisation Programme study (BSP164) for the establishment of a new European Pharmacopoeia (Ph. Eur.) Biological Reference Preparation (BRP) for golimumab, a fully human therapeutic TNF targeting monoclonal antibody, has been published in the online...
Strengthening European SoHO systems – The Council of Europe and European Union step-up co-operation
The European Directorate for the Quality of Medicines & HealthCare (EDQM), of the Council of Europe, and the European Union (EU) have just signed a new agreement aimed at further enhancing substances of human origin (SoHO) systems and strengthening their capacity across Europe and beyond. Through...
EDQM reference standards monthly newsletter – January 2025
7 new European Pharmacopoeia reference standards and 20 replacement batches released in January 2025 The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just published its monthly newsletter on the situation of European Pharmacopoeia reference standards. It includes...
EDQM On Air – COVID-19: Rising to the challenge of a global crisis
EDQM On Air, the podcast from the European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe, has just released a new episode! The SARS-CoV-2 virus, which causes COVID-19, triggered a global pandemic on a staggering scale in 2020. It brought entire societies to...
Recommendation CM/Rec(2024)8 on the family approach to discuss deceased organ and tissue donation
The Committee of Ministers of the Council of Europe adopted Recommendation CM/Rec(2024)8 on the family approach to discuss deceased organ and tissue donation on 27 November 2024. This instrument promotes a family-centred approach to discussing organ and tissue donation after a person’s death....
Pharmacopoeial Discussion Group achievements
The Pharmacopoeial Discussion Group (PDG) held its annual meeting on 1 and 2 October 2024 in Strasbourg, France. The meeting marked the one-year anniversary of the PDG working with an expanded team of four members (see “PDG welcomes IPC as a member”). The PDG includes the European Pharmacopoeia...
Publication of BSP establishment study for hepatitis A virus coating reagent BRR
The Biological Standardisation Programme (BSP) recently established batch 2 of the Ph. Eur. Hepatitis A virus Coating Reagent Biological Reference Reagent (BRR) for use in the in vitro potency assay of hepatitis A vaccines by ELISA. The BRR was established in an international collaborative study...
Certification monthly report of activities: End of December 2024
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of December 2024 Certification Monthly Report For more information, access the Certification Database.
Implementation of the European Pharmacopoeia Supplement 11.8 – Notification for CEP holders
Supplement 11.8 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 2025, and to follow the...
CEP holders invited to comment on draft monographs published in Pharmeuropa 37.1
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 37.1. The table below lists the substances...
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...
Swan song for general animal safety tests: another significant milestone in the elimination of animal tests from the Ph. Eur.
At its 180th session in November 2024, the European Pharmacopoeia Commission (EPC) decided to suppress the general chapters on Pyrogens (2.6.8), Histamine (2.6.10) and Depressor substances (2.6.11) from the European Pharmacopoeia (Ph. Eur.), all of which require the use of animals. It was also...
Publication of three new Ph. Eur. general chapters for plastic materials for containers
After several years of work by the experts of Group 16 (Plastic materials, plastic containers and closures), three new general chapters on plastic materials were adopted by the European Pharmacopoeia Commission at its 180th session in November 2024. These general chapters – Cyclo-olefin polymers...
EDQM reference standards monthly newsletter – December 2024
3 new European Pharmacopoeia reference standards and 15 replacement batches released in December 2024 The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just published its monthly newsletter on the situation of European Pharmacopoeia reference standards. It includes...
European Pharmacopoeia Commission adopts first three general texts on mRNA vaccines
At its 180th session in November 2024, the European Pharmacopoeia Commission (EPC) adopted three new general texts relating to the production and quality control of mRNA vaccines and their components, namely: mRNA vaccines for human use (5.36), covering mRNA packaged in lipid nanoparticles, i.e....
Pharmeuropa 37.1 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 37.1 is 31 March 2025. Users and interested parties are welcome to comment on these drafts. It should be...
Amiodarone capsules monograph published in European Paediatric Formulary
A new monograph, Amiodarone hydrochloride, capsules (5-200 mg), developed by the European Paediatric Formulary (PaedF) Working Party, been added to the European Paediatric Formulary (Formulary) following a successful public. With the publication of this monograph, the Formulary (which is not...
2024, a year to remember
A busy and eventful year comes to a close for the European Directorate for the Quality of Medicines & HealthCare (EDQM), and it is time to look back, take stock of our successes and accomplishments and peek into the new year to see what challenges and opportunities await. The 60th anniversary of...
Compliance and safety of food contact materials and articles – New EDQM guide available
The European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe has published the “Technical guide on documentation supporting compliance and safety of food contact materials and articles”. This new user-friendly guide, designed to help business operators...
Online publication of Erythropoietin CRS establishment study
Batch 2 of the European Pharmacopoeia (Ph. Eur.) Erythropoietin for physicochemical tests Chemical Reference Substance (CRS) was adopted by the Ph. Eur. Commission in November 2023. This CRS is used as a reference for capillary zone electrophoresis, peptide mapping, and polyacrylamide gel...
26-27 March 2025
EDQM stakeholder event - Plasma Supply Continuity
SAVE THE DATE! Join us for an important stakeholder event on the theme “Plasma Supply Continuity”. Hosted by the European Directorate for the Quality of Medicines & HealthCare (EDQM), this in-person forum will take place in Strasbourg on 26 and 27 March 2025. This event will provide an update on...
New FAQ on EDQM HelpDesk: system suitability test in assay chromatographic procedures
Following queries received from users through the EDQM HelpDesk, a new FAQ on the system suitability test (selectivity) in assays by chromatographic procedures has been added to the existing series of FAQs dealing with the European Pharmacopoeia & International harmonisation. This addition is...
European Pharmacopoeia Supplement 11.8 now available
The European Pharmacopoeia (Ph. Eur.) Supplement 11.8 is now available and will be applicable in 39 European countries as of 1 July 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...
Information for CEP applicants - EDQM-DCEP non-working days in 2025
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,...
CEP Procedure: 30 years of scientific excellence
This year marks the 30th anniversary of the Certification of suitability to the monographs of the European Pharmacopoeia (CEP) Procedure, established by the European Directorate for the Quality of Medicines & HealthCare (EDQM). Since 1994, the CEP procedure has significantly contributed to the...
New addition to the work programme of the European Paediatric Formulary
The European Pharmacopoeia Commission approved the addition of a new monograph on Pyridoxine, oral liquid to the European Paediatric Formulary work programme at its session in November 2024. The complete work programme is available here. Interested parties may contact the Secretariat to propose...
Certification monthly report of activities: End of November 2024
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of November 2024 Certification Monthly Report For more information, access the Certification Database.
European Drug Shortages Formulary project: approval of framework and procedure documents
The European Drug Shortages Formulary (EDSForm) project plays a key role in the EDQM’s efforts to address medicine shortages in Europe. With work led by the European Drug Shortages Formulary Working Party (EDSForm WP), the aim of the project is to provide guidance for hospital and community...
Collaborative study on validation of an ELISA method for determination of physical particle titre of AAV2 vectors: outcome published
The Gene Therapy Working Group (GTWG) of the General European Official Medicines Control Laboratory (OMCL) Network (GEON) organises collaborative studies to validate analytical methods for the quality control of gene therapy products. A recent study focused on the validation of an ELISA method...
Increasing the EDQM’s global impact: Brazilian health authority to rely on CEP evaluation procedure
In a decision advancing international convergence in pharmaceuticals worldwide, the Brazilian health regulatory authority, Agência Nacional de Vigilância Sanitária (ANVISA), has decided to consider evaluation reports from international regulatory bodies in their decision-making process . This...
EDQM reference standards monthly newsletter – November 2024
5 new European Pharmacopoeia reference standard and 17 replacement batches released in November 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...
Outcome of the 180th session of the European Pharmacopoeia Commission, November 2024
The European Pharmacopoeia Commission (EPC) held its 180th session on 19 and 20 November 2024. A summary of its outcome is available in the infographic below. Highlights will be published shortly on the website of the European Directorate for Quality of Medicines & HealthCare (EDQM) and the full...
CEPs for sterile substances – Guideline for preparing your dossier now available
The European Directorate for the Quality of Medicines & HealthCare (EDQM) wishes to provide further guidance to applicants for the preparation of their dossiers to obtain a Certificate of Suitability (CEP) for a sterile substance. This document clarifies the conditions for acceptability of this...
General chapter Elemental Impurities (G-07) harmonised by the Pharmacopoeial Discussion Group
The new harmonised general chapter “Elemental Impurities (G-07)” was signed-off by the Pharmacopoeial Discussion Group (PDG) on 19 June 2024. The PDG brings together the European Pharmacopoeia (Ph. Eur.), Indian Pharmacopoeia Commission (IPC), Japanese Pharmacopoeia (JP) and the United States...
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...
Find information on the EDQM’s response to protection of animal rights (3Rs), to N-nitrosamine contamination and the COVID-19 pandemic.