Newsroom
SAVE THE DATE! “Healthcare and medicines: meeting patient’s needs through Council of Europe/EDQM and national programmes” - Joint EDQM - INFARMED Symposium (5-6 May 2026)
The European Directorate for the Quality of Medicines & HealthCare (EDQM) is pleased to announce a symposium co-organised with the Portuguese National Authority of Medicines and Health Products (INFARMED), entitled “Healthcare and medicines: meeting patient’s needs through Council of Europe/EDQM...
CD-P-TO adopts position paper to combat unethical travel for transplantation
At its 34th plenary meeting in Kalamata (9-10 October 2025), Greece, the European Committee on Organ Transplantation (CD-P-TO) adopted a landmark position paper addressing the online promotion and facilitation of unethical international travel for transplantation. Developed by the Network of...
CD-P-TO issues urgent call to safeguard diagnostic tools for organ and tissue donation
The European Committee on Organ Transplantation (CD-P-TO) has adopted a critical position paper highlighting the unintended consequences of EU regulations on medical devices (MDR) and in vitro diagnostic devices (IVDR) for the field of substances of human origin (SoHO). The paper warns that the...
European Pharmacopoeia Issue 12.2 now available
The European Pharmacopoeia (Ph. Eur.) Issue 12.2 is now available and will be applicable in 39 European countries as of 1 April 2026. This issue is available on the Ph. Eur. Online platform for all holders of a valid 365-day licence, along with all texts currently in force and texts published...
EDQM defining harmonised activity data set for blood and blood components
The European Directorate for the Quality of Medicines & HealthCare (EDQM), in collaboration with the European Commission (DG SANTE), is co-ordinating a project to define a minimum activity data set for blood and blood components, in line with Article 41 of Regulation (EU) 2024/1938 on standards...
Changes to e-submission requirements for CEP applications
The EDQM will soon be introducing automation to improve its process for receiving CEP submissions. As of 1 November 2025, applicants will have to comply with the following requirements: The eCTD validation report must be provided as part of eCTD submissions: Submissions with eCTD sections must be...
European Paediatric Formulary: enhancing accessibility and functionality
The European Paediatric Formulary platform continues to evolve, boosting its usability and reach across Europe. In a significant step forward, all texts published in the formulary are now available in French. This not only broadens access for French-speaking healthcare professionals, but brings...
Secretary General: Organ donation depends on trust. We must defend it.
Statement on the occasion of European Day for Organ, Tissue and Cell Donation (11 October) The Council of Europe Secretary General, Alain Berset, made the following statement ahead of European Donation Day (11 October): “Organ, tissue and cell donation gives countless people across Europe a...
Certification monthly report of activities: End of September 2025
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of September 2025 Certification Monthly Report For more information, access the Certification Database.
Regulatory Reliance and Fast track assessment in the CEP procedure
According to the World Health Organization (WHO), “Good reliance practices are anchored in overall good regulatory practices (GRP), which provide a means for establishing sound, affordable, effective regulation of medical products as an important part of health system strengthening. If...
New quantification method for suspected adulteration with ethylene glycol and diethylene glycol to be included in the Ph. Eur.
In light of continuing reports of paediatric syrups contaminated with ethylene glycol (EG) and diethylene glycol (DEG)...
Customer Care - Head of Section
Customer Care - Head of Section Grade: A1/A2 Salary: from € 4 857 (A1) and € 6 207 (A2) per month (net) Location: Strasbourg (France) Reference: 1067/2025 Deadline for applications: 27 October 2025 Are you a dynamic leader with a passion for customer experience and stakeholder...
Transform lives – Join the network of the European Pharmacopoeia
The European Directorate for the Quality of Medicines & HealthCare (EDQM) is launching a new call for experts to join the network of the European Pharmacopoeia (Ph. Eur.). Behind every quality medicine standard adopted by the European Pharmacopoeia Commission (EPC) is a network of dedicated...
CEP holders invited to comment on draft monographs published in Pharmeuropa 37.4
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 37.4. The table below lists the substances...
Pharmeuropa 37.4 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 37.4 is 31 December 2025. Users and interested parties are welcome to comment on these drafts. It should...
European Drug Shortages Formulary (EDSForm) takes shape: EDQM publishes first EDSForm texts for public consultation
The European Directorate for the Quality of Medicines & HealthCare (EDQM) is extremely pleased to announce the public consultation on the first three texts of its second formulary after the European Paediatric Formulary (launched in 2019). Healthcare professionals and interested parties across...
EDQM reference standards monthly newsletter – September 2025
14 new European Pharmacopoeia reference standard and 17 replacement batches released in September 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 webinar on how to read a CEP for all users
The European Directorate for the Quality of Medicines & HealthCare (EDQM) will hold a free webinar on 25 November 2025 for all interested users of Certificates of suitability to the monographs of the European Pharmacopoeia (CEPs), following up on the recently revised guideline “How to read a...
EDQM publishes new guidelines on the classification of active pharmaceutical substances as regards their supply
The European Directorate for the Quality of Medicines & Healthcare (EDQM) has published “Guidelines on key considerations in issuing recommendations on the classification of active substances as regards their supply (prescription and non-prescription status)”, introducing the new approach to...
EDQM to play key role in strengthening African medicines regulation
The European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of Europe, is proud to announce its participation in a major European Union (EU) initiative aimed at strengthening regulatory systems for medicines across Sub-Saharan Africa. The EDQM, as part of a grant agreement...
To help you find the relevant news, filter the list using the categories below.