Newsroom
BSP study publication: Somatropin/desamidosomatropin resolution mixture CRS 2
An article on the outcome of the Biological Standardisation Programme (BSP) study for the establishment of the European Pharmacopoeia (Ph. Eur.) Somatropin/desamidosomatropin resolution mixture Chemical Reference Substance batch 2 is now available free online. The article has been published in...
Quality control of inorganic substances and synthetic and semi-synthetic organic substances
Call for experts: join the Ph. Eur. network
Quality control of inorganic substances and synthetic and semi-synthetic organic substances
EDQM ISO 9001:2015 certification renewed
The European Directorate for the Quality of Medicines & HealthCare (EDQM) successfully obtained the renewal of its certification according to the ISO 9001:2015 standard from the AFNOR certification body, confirming the compliance of the Quality Management System of the EDQM with this standard....
NEW 5th European Training Course on Quality Management for Blood Establishments
The European Directorate for the Quality of Medicines & HealthCare (EDQM)/Council of Europe (CoE) is organising a FREE training course on audit practices for blood establishments, with the support of the European Commission. Auditing, in addition to being a key driver in the continual improvement...
Job offer: Study Director – Analytical Chemistry
Join our team as a Study Director in analytical chemistry in our laboratory - Apply before 06/07/2022.
Pharmeuropa Bio & Scientific Notes now accessible without registration
Job offer! Join our team as a Study Director in analytical chemistry in our laboratory - Apply before 06/07/2022.
2021 Highlights – EDQM annual report now available
Download: 2021 Highlights – EDQM annual report The 2021 annual report of the European Directorate for the Quality of Medicines & HealthCare (EDQM) is now available, providing a comprehensive overview of its activities and achievements. New to this edition is a four-page summary of key facts and...
New option for shipments to Ukraine and the Republic of Moldova
The EDQM is now able to offer a new option for shipments to Ukraine and the Republic of Moldova. Ukrainian and Moldovan users will receive a dedicated e-mail explaining how to proceed. If you would like more information, please contact us through our HelpDesk.
Certification monthly report of activities: End of May 2022
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of May Certification Monthly Report For more information, access the Certification Database.
OMCLs participate in international regulatory collaboration on the analysis of nitrosamines in metformin‑containing medicines
In 2020, batches of metformin-containing medicines were recalled because they contained N-nitrosodimethylamine (NDMA), a probable human carcinogen, above the acceptable daily intake (AI) of 96 ng/day. Prior to the recalls, Official Medicines Control Laboratories (OMCLs) from the OMCL Network...
Register now for our upcoming training programme on the Ph. Eur., reference standards and CEPs
8 independent modules – 8 topics – 8 Q&A sessions – All LIVE! This 100% virtual training will focus on chemically defined active substances and cover all the fundamentals related to the use of the European Pharmacopoeia and its reference standards, as well as the procedure for Certification of...
Job offer: European Pharmacopoeia Programme and Process Manager
If you meet the eligibility criteria and are a citizen of one of the 46 member states of the Council of Europe, please submit your application using our online recruitment website.
Temporary job offer: Assistant
Salary: from €2 460 (netto/month) Contract type: temporary (until end of 2022, renewable in 2023) Place: Strasbourg (France) We're looking for several individuals to operate secretarial duties, highly motivated and who can quickly slot in to our existing structure and immediately operate...
Call for experts: join the Ph. Eur. network!
The European Pharmacopoeia (Ph. Eur.) is seeking independent scientific experts to join its groups of experts and working parties. Professionals from national authorities (e.g. pharmacopoeial authorities, official medicines control laboratories, licensing authorities and inspectorates), the...
Ph. Eur. Commission adopts first “horizontal standard” for monoclonal antibodies
At its 172nd session in March 2022, the European Pharmacopoeia (Ph. Eur.) Commission adopted a new general chapter, Cell-based assay for potency determination of TNF-alpha antagonists (2.7.26), the first of three planned new horizontal standards for monoclonal antibodies (mAbs). The adoption of...
European Pharmacopoeia 11th Edition (11.0-11.2) – Subscriptions now open!
The 2023 subscriptions to the European Pharmacopoeia (Ph. Eur.), including the initial release (11.0) and the first two supplements (11.1-11.2), are now available for sale in the WebStore of the European Directorate for the Quality of Medicines & HealthCare (EDQM). Subscribers may choose either...
Certification monthly report of activities: End of April 2022
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of April 2022 Certification Monthly Report For more information, access the Certification Database.
New BSP study publication: Heparin Low-Molecular-Mass for Assay BRP
An article on the outcome of the Biological Standardisation Programme (BSP) study for the establishment of the European Pharmacopoeia (Ph. Eur.) Heparin Low-Molecular-Mass for Assay Biological Reference Preparation batch 11 is now available online. The article has been published in Pharmeuropa...
24 replacement batches released in April 2022
Replacement batches for Ph. Eur. reference standards Removal Future removal Change of sales units Information on change of price Change of EDQM storage/shipping conditions See also: Content of the Ph. Eur. RS catalogue How to place an RS order The EDQM announces the release of: 24 replacement...
New policy for the development of monographs on medicinal products containing chemically defined active substance hydrates or solvates
At its 172nd session in March 2022, the European Pharmacopoeia (Ph. Eur.) Commission approved a new policy for the development of monographs on medicinal products containing chemically defined active substances in hydrate or solvate form. This policy differentiates between hydrates, which have...