Newsroom European Pharmacopoeia
10th Edition 10.0-10.2 – Subscriptions now open!
The 2020 subscriptions are now available for sale on our webstore.
New approach for extraneous agent testing in IVMPs: the EDQM provides further support to its users over the long term
So you missed the webinars on 1 April but have questions about the updated approach to extraneous agent testing in IVMPs? To provide long-term user support on IVMP testing policy, the EDQM is making two documents available. The first summarises what has changed and why, the second summarises the...
Ph. Eur. Commission adopts revised monograph on Erythropoietin concentrated solution (1316)
The approach to the elaboration of European Pharmacopoeia (Ph. Eur.) monographs for biotherapeutics has significantly evolved in recent years. In particular, where monographs on complex biotherapeutics are concerned, the emphasis is now placed on allowing greater flexibility as a means of better...
Pharmeuropa 32.3 just released
All new texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments on Pharmeuropa 32.3 is 30 September 2020. Users and interested parties are welcome to comment on these drafts. It should be noted that: although draft...
Last chance to comment: analysis of N-nitrosamine impurities
The European Pharmacopoeia (Ph. Eur.) published its new general chapter on the analysis of N-nitrosamine impurities in active substances (2.4.36) for a 3-month public consultation in Pharmeuropa 32.2. The closing date for public comments was 30 June 2020. Given the exceptional circumstances due...
Outcome of the 167th session of the European Pharmacopoeia Commission
The 167th session of the European Pharmacopoeia (Ph. Eur.) Commission on 23 June 2020 was the first ever to be held online, due to the COVID-19 pandemic. This unprecedented meeting successfully brought together over 130 members of the Ph. Eur. Commission, its 60 groups of experts and working...
European Pharmacopoeia Supplement 10.3 now available
The European Pharmacopoeia (Ph. Eur.) Supplement 10.3 is now available and will be applicable in 39 European countries as of 1 January 2021.
Recombinant factor C: new Ph. Eur. chapter available as of 1 July 2020
Published in European Pharmacopoeia (Ph. Eur.) Supplement 10.3, the new general chapter 2.6.32. Test for bacterial endotoxins using recombinant factor C describes a test for bacterial endotoxins (BET) that can be used as an alternative to the classic limulus amoebocyte lysate (LAL)-based methods...
Elemental impurities in plastic materials: extension of Pharmeuropa commenting period for chapter 2.4.35
Due to high public interest and the importance of the text, it has been decided to extend the consultation period for the new general chapter on Extractable elements in plastic materials for pharmaceutical use (2.4.35) to give stakeholders more time to comment. Originally published in Pharmeuropa...
Ph. Eur. Commission consults stakeholders on revised Raman spectroscopy chapter
The European Pharmacopoeia (Ph. Eur.) is seeking feedback on revised chapter 2.2.48 on Raman Spectroscopy. Raman spectrometers are increasingly deployed in the pharmaceutical environment. Offering user-friendly interfaces and rapid, non-destructive measurements generating essential information...
Oxygen 98%: Ph. Eur. receives valuable feedback on new oxygen quality
The EDQM would like to warmly thank its stakeholders for their invaluable feedback and their commitment to the work of the European Pharmacopoeia (Ph. Eur.). About 40 different interested parties, including gas producers and industry associations, National Pharmacopoeia Authorities (NPAs),...
EDQM continues to support COVID-19 vaccine developers by providing selected training materials
Further to the publication of the COVID-19 vaccine developers’ package of pharmacopoeial texts (see “ EDQM provides COVID-19 vaccine developers with free access to quality standards applicable in Europe”), the EDQM has compiled a companion list of training materials on the European Pharmacopoeia...
EDQM provides COVID-19 vaccine developers with free access to quality standards applicable in Europe
The EDQM is committed to supporting vaccine developers during the coronavirus disease (COVID-19) pandemic – as well as contributing to the wider global effort to combat the virus – by openly sharing knowledge and offering temporary free access to relevant guidance and standards. The EDQM and the...
Ph. Eur. Training Webinar Sessions: Live, Interactive & Online
The EDQM is organising four free webinar training sessions on the European Pharmacopoeia and related activities of the EDQM. These webinars will cover many important aspects of the work and procedures of the European Pharmacopoeia (e.g. impurity controls or new and revised chapters), the...
European Pharmacopoeia welcomes Mexico as observer state
The European Pharmacopoeia Commission granted observer status to Mexico during its 166th session (March 2020). This decision demonstrates the dynamism of the European Pharmacopoeia (Ph. Eur.), which now has 30 observers from around the world in addition to the 39 European countries and the...
Updated technical guide for elaborating and using monographs on vaccines and IVMPs now available
The new edition of the Technical guide for the elaboration and use of monographs for immunological veterinary medicinal products (2020) was approved by the European Pharmacopoeia Commission at its 166th session. Fully updated to take into account the latest revisions of European Pharmacopoeia...
Subscriptions now open for the European Pharmacopoeia 10th Edition, Supplements 10.3-10.5
The 2021 subscriptions to the European Pharmacopoeia Supplements 10.3-10.5 are now available on the EDQM WebStore. Two subscription formats are available: Electronic version (access until 31 December 2021 - bilingual English and French) Subscribers can choose between two options: individual...
European Pharmacopoeia: Adoption of a new general chapter on Multivariate Statistical Process Control
At its 166th session (March 2020), the European Pharmacopoeia (Ph. Eur.) Commission adopted a new chapter on Multivariate Statistical Process Control (5.28). The Ph. Eur. is the first pharmacopoeia to tackle this topic. The Commission also adopted a revised version of chapter 5.25 on Process...
Outcome of the 166th session European Pharmacopoeia Commission
By mid-March this year, announcements regarding the postponement or cancellation of meetings due to the COVID-19 pandemic had been made and an almost global lockdown was underway. In this unprecedented context, the European Pharmacopoeia (Ph. Eur.) Commission and its 60 groups of experts and...
Pharmacopoeial Discussion Group videoconference meeting - March 2020
The Pharmacopoeial Discussion Group (PDG) held its interim videoconference on Thursday 12 March 2020. The PDG – which brings together the European Pharmacopoeia (Ph. Eur.), the Japanese Pharmacopoeia (JP) and the United States Pharmacopeia (USP), with WHO (International Pharmacopoeia) as...