Newsroom European Pharmacopoeia
New Pharmeuropa Bio & Scientific Notes article now online: Human immunoglobulin for ACA BRP
A new scientific article on the outcome of a recently concluded Biological Standardisation Programme (BSP) study has been published in Pharmeuropa Bio & Scientific Notes 2022. Four replacement batches of the European Pharmacopoeia (Ph. Eur.) Biological Reference Preparation (BRP) for Human...
Proceedings of Workshop on alternatives to animal testing in Quality Control of Veterinary Vaccines now available
The proceedings of the workshop "Novel in-vitro model as alternative to in vivo toxoid vaccines testing: Clostridium septicum vaccine as proof of concept" have been published in FreePub, a free online EDQM journal. The event, held in March 2021, was jointly organised by the European Directorate...
European Pharmacopoeia 11th Edition International Conference: early-bird registration now available
Registration is now open for the international conference to mark the launch of 11th Edition of the European Pharmacopoeia (Ph. Eur.). The conference will take place from 19 to 21 September 2022, both in-person, in Strasbourg (France), and virtually. The main themes of the conference are...
Outcome of the 172nd session of the European Pharmacopoeia Commission, March 2022
The European Pharmacopoeia (Ph. Eur.) Commission held its 172nd session on 22 and 23 March 2022. The Commission adopted 78 texts at this session, to be published in Ph. Eur. Supplement 11.1 and be effective as of 1 April 2023. These 78 texts included six new monographs and one new general...
Ph. Eur. Commission elects its new Chair at 172nd Session
The European Pharmacopoeia (Ph. Eur.) Commission held its 172nd Session on 22 and 23 March 2022. Among other decisions, the Commission elected its new Chair, Professor Salvador Cañigueral. Professor Cañigueral has been first Vice-chair to the Commission since June 2019. He will take up his duties...
New EDQM website, redesigned to better serve your needs – Now online!
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just launched its redesigned website. Discover the following new features. Improved, user-friendly navigation by main topics. This means faster access – in fewer clicks – to the information you need using the top menu...
Pharmeuropa 34.2 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 34.2 is 30 June 2022. Users and interested parties are welcome to comment on these drafts. It should be...
Ph. Eur. to launch survey for the use of total organic carbon (TOC) test as a replacement of oxidisable substances test in Water for injections
The experts of the European Pharmacopoeia (Ph. Eur.) are considering replacing the test for oxidisable substances by the test for total organic carbon (TOC) in the Tests section of the “Sterilised water for injections” part of the monograph on Water for injections (0169). This change has been...
EDQM event "Quality requirements for nanomedicines"
The COVID-19 pandemic and the emergence of mRNA vaccines have highlighted the importance of nanoparticle formulations – especially lipid-based systems – used for nucleic acid-based APIs. The success of SARS-CoV-2 vaccination programmes around the globe has demonstrated that these...
SAVE THE DATE! Conference celebrating the publication of the 11th Edition of the European Pharmacopoeia (19-21 September 2022)
After almost two years of online events, the European Directorate for the Quality of Medicines & HealthCare (EDQM) is eager to announce the organisation of an international conference to celebrate the publication of the 11th Edition of the European Pharmacopoeia (Ph. Eur.). This in-person event...
PHARMEUROPA BIO & SCIENTIFIC NOTES publication – Weighing according to the European Pharmacopoeia
An article on weighing according to the European Pharmacopoeia has been published in Pharmeuropa Bio & Scientific Notes and is referenced in Medline/PubMed®. Weighing is a key activity in every quality control laboratory as it is one of the first steps in the preparation of samples and reagents...
New Webinar: What has changed in the Ph. Eur. General Notices?
The General Notices is the European Pharmacopoeia (Ph. Eur.) go-to chapter that contains important information applicable to all Ph. Eur. texts. Its content is relevant for any user seeking to understand not just the conventional expressions and terminology used throughout the Ph. Eur. but also...
Ph. Eur. Commission adopts harmonised general chapter 2.2.46. Chromatographic separation techniques
At its 171st session in November 2021, the European Pharmacopoeia (Ph. Eur.) Commission adopted a new version of one of its widely used general chapters, Chromatographic separation techniques (2.2.46). The text has been revised to take account of the pharmacopoeial harmonisation text, signed-off...
Ph. Eur. tentative policy on assay RSDs for monographs on medicinal products containing chemically defined active substances – End of trial period postponed
When the experimental results allow, draft monographs will be published in Pharmeuropa with a peak area repeatability requirement of RSD ≤ 1.0% (n=6) determined on a solution containing the active substance CRS. The trial period for this policy has been prolonged until the end of February 2023,...
All you ever wanted to know about procedure 4 but never dared ask!
This document is intended to help stakeholders understand the advantages of applying for a monograph elaboration via procedure 4. It describes how Group P4 has elaborated P4 monographs over the last 10 years. It also applies to monographs on biotherapeutics as elaborated by the P4bio Working...
New for non-liquid, non-parenterally administered veterinary vaccines: maximum bioburden limit replaces sterility requirements
Sterility requirements in non-liquid and non-parenterally administered veterinary vaccine monographs have been replaced by a maximum bioburden limit to allow the development of new innovative vaccine presentation forms while maintaining the same safety guarantees. The revised sterility...
Revised Colony-forming cell assay for human haematopoietic progenitor cells (2.7.28) and Nucleated cell count and viability (2.7.29) in Pharmeuropa 34.1
The European Pharmacopoeia (Ph. Eur.) is seeking stakeholder feedback on the revised general chapters Colony-forming cell assay for human haematopoietic progenitor cells (2.7.28) and Nucleated cell count and viability (2.7.29), published in this quarter’s issue of Pharmeuropa (34.1) for comment...
Pharmeuropa 34.1 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 34.1 is 31 March 2022. Users and interested parties are welcome to comment on these drafts. It should be...
European Pharmacopoeia Supplement 10.8 now available
The European Pharmacopoeia (Ph. Eur.) Supplement 10.8 is now available and will be applicable in 39 European countries as of 1 July 2022. This volume is included in the 2022 subscription (10.6, 10.7 and 10.8) to the 10th Edition of the Ph. Eur. Subscriptions for print and/or electronic versions...
Outcome of the 171st session of the European Pharmacopoeia Commission, November 2021
The 171st session of the European Pharmacopoeia (Ph. Eur.) Commission took place on 23 and 24 November 2021. At this session, the Commission adopted 75 texts for publication in the 11th Edition of the European Pharmacopoeia: 66 revised texts and nine new texts, including: the revised and...