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3 new reference standards and 13 replacement batches released in December 2019
New releases: New Ph. Eur. reference standards Replacement batches for Ph. Eur. reference standards Removal Future removal Change of sales unit Change of EDQM storage/shipping conditions Current non-availability See also: Content of the Ph. Eur. RS catalogue How to place an RS order The EDQM...
Pharmeuropa 32.1 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 32.1 is 31 March 2020. Users and interested parties are welcome to comment on these drafts. It should be noted that: although draft...
Ph. Eur. Supplement 10.2 available now
The 10.2 supplement of the European Pharmacopoeia is now available and will be applicable in 38 European countries as of 1 July 2020. This volume is included in the 2020 subscription (10.0, 10.1 and 10.2) to the 10th Edition of the European Pharmacopoeia. This subscription is available for...
Ph. Eur. seeks feedback on new general chapter on pyrrolizidine alkaloids
The European Pharmacopoeia (Ph. Eur.) has launched a public consultation on its new general chapter 2.8.26 on contaminant pyrrolizidine alkaloids. Users and concerned parties can submit their comments in Pharmeuropa 32.1 until 31 March 2020. Pyrrolizidine alkaloids are nitrogen-containing...
European Paediatric Formulary online
The EDQM is pleased to announce that the European Paediatric Formulary is now available free of charge on a dedicated online platform. This is a major achievement for the PaedForm Working Party and all the stakeholders involved, since it not only embodies several years’ work and dedication to the...
Detection of N-nitrosamine impurities: the Ph. Eur. launches a public consultation on the revised general monograph Substances for pharmaceutical use (2034)
The Ph. Eur. Commission proposes to revise the general monograph on Substances for pharmaceutical use (2034). This proposal has been made further to the European Commission referral C(2019)2698 of 2 April 2019 and the review initiated by the European Medicines Agency (EMA) in September 2019 under...
Outcome of the 165th European Pharmacopoeia Commission
During its 165th session, held in Strasbourg on 26 and 27 November 2019, the European Pharmacopoeia (Ph. Eur.) Commission (re)appointed more than 850 experts to its current 21 groups of experts and 39 active working parties for a new term running from November 2019 to November 2022. The list of...
Consultation deadline for revised dosage form monographs and general chapters drawing near
The European Pharmacopoeia (Ph. Eur.) Commission is undertaking a review of the dosage form monographs and related general chapters. Five different texts finalised by Ph. Eur. Group of Experts 12 have been launched for public consultation in Pharmeuropa 31.4 until 31 December 2019. The general...
9 new reference standards and 20 replacement batches released in November 2019
New releases New Ph. Eur. reference standards Replacement batches for Ph. Eur. reference standards Removal Future removal Change of sales unit Change of EDQM storage/shipping conditions Current non-availability Content of the Ph. Eur. RS catalogue How to place an RS order The EDQM announces the...
EDQM launches a new HelpDesk
As part of its efforts to improve customer service, the EDQM has developed a streamlined version of its HelpDesk and FAQs platform. The new HelpDesk was redesigned on the basis of feedback received from users and now benefits from a more intuitive interface, which is expected to enhance customer...
Ph. Eur. launches public consultation on general chapter 2.4.20. Determination of elemental impurities
The European Pharmacopoeia (Ph. Eur.) Commission is consulting its stakeholders on general chapter 2.4.20. Determination of elemental impurities. Updated in the context of discussions within the Pharmacopoeial Discussion Group (PDG), the text is intended to become the new harmonised standard for...
New secondary site of the EDQM to be opened and inaugurated on 15 November 2019
The new secondary site of the EDQM, being opened and inaugurated on 15 November 2019, will enable the safe storage of contingency stocks of European Pharmacopoeia reference standards and ensure their distribution worldwide in the event of major incidents at its main site in Strasbourg. European...
7 new reference standards and 23 replacement batches released in October 2019
The EDQM announces: New Ph. Eur. reference standards Replacement batches for Ph. Eur. reference standards Removal Future removal Change of sales unit Change of EDQM storage/shipping conditions Current non-availability Content of the Ph. Eur. RS catalogue How to place an RS order 7 New Ph. Eur....
Warning: Phishing campaign
A phishing campaign has been launched from the internet by impersonating an EDQM user in e-mails aimed at infecting the recipients’ computers. These e-mails have been sent from outside the EDQM’s infrastructure, which is why the EDQM has no control over them. They have no connection with the...
Announcement to all CEP holders for synthesised APIs regarding presence of nitrosamines
Since July 2018, EDQM has been actively involved in activities related to the detection and control of nitrosamine impurities in sartan active substances (APIs) with a tetrazole ring for which there are CEPs. These activities have included contacting CEP holders to request data and corrective...
Sign up today! FREE training on the “Management of Extraneous Agent 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 content of the training webinars which took place on 1 April 2020.
Ph. Eur.: new approach to extraneous agents testing of IVMPs
The European Pharmacopoeia Commission adopted 43 texts related to its new approach to extraneous agents testing of immunological veterinary medicinal products (IVMPs). From starting material to final product, users will now have to follow an overall risk-management approach to ensure they...
Pharmeuropa 31.4 just released
All new texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. Users and interested parties are welcome to comment on these drafts. It should be noted that: Although draft monographs must not be regarded as official standards, they will, once...
European Pharmacopoeia Supplement 10.1 available now
Supplement 10.1 of the European Pharmacopoeia is now available; it will be applicable in 38 European countries as of 1 April 2020. This volume is included in the 2020 subscription to the 10th Edition of European Pharmacopoeia (covering supplements 10.0, 10.1 and 10.2). This subscription is...
Just released: Newsletter Transplant 2019
The EDQM/Council of Europe publishes Newsletter Transplant, which gives data on organ, tissue and cell donation and transplantation at the European and international levels. This work is co-ordinated by the Spanish National Transplant Organisation (ONT), which analyses the data collected through...
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