Newsroom
Senior scientific assistant – Official Medicines Control Laboratory (OMCL) Network – Batch release (human and veterinary)
The EDQM’s Networks division is seeking a temporary Senior scientific assistant to join the OMCL Network team responsible for official batch release for human and veterinary medicines.
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 4th 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...
Public holidays: EDQM offices closed from 18 to 21 April 2025
Due to public holidays in France, the European Directorate for the Quality of Medicines & HealthCare (EDQM) will be closed from Friday 18 April to Monday 21 April 2025 included.
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...
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...
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...
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...
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...
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...
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.
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...
Find information on the EDQM’s response to protection of animal rights (3Rs), to N-nitrosamine contamination and the COVID-19 pandemic.