Newsroom European Pharmacopoeia
Implementation of the European Pharmacopoeia Supplement 10.7 – Notification for CEP holders
Supplement 10.7 of the European Pharmacopoeia (Ph. Eur.) is now available. Holders of Certificates of suitability to the monographs of the Ph. Eur. (CEPs) are invited to update their applications according to the revised monographs that will be implemented on 1 April 2022, and to follow the...
PDG prepares pilot for global expansion of membership
The Pharmacopoeial Discussion Group (PDG), which brings together the European Pharmacopoeia (Ph. Eur.), the Japanese Pharmacopoeia (JP) and the United States Pharmacopeia (USP), with the World Health Organization (WHO) as an observer, is preparing a pilot to integrate additional world...
European Pharmacopoeia device version to be discontinued
The European Directorate for the Quality of Medicines & HealthCare (EDQM) will discontinue the device version of the European Pharmacopoeia (Ph. Eur.) as of the 11th Edition, which is scheduled for publication in July 2022, and focus efforts on the online and paper versions. The EDQM was the...
Revised osmolality chapter for public comment in Pharmeuropa
The European Pharmacopoeia (Ph. Eur.) is seeking stakeholder feedback on the revised general chapter on Osmolality (2.2.35), published in this quarter’s issue of Pharmeuropa (33.4) for comment (deadline 31 December 2021). The revision work focused on the osmolality reference solutions using...
Draft monograph on Oxygen (98 per cent) published for comment in Pharmeuropa
A new draft monograph, Oxygen (98 per cent) (3098), has been published for comment in this quarter’s issue of Pharmeuropa (33.4), the European Pharmacopoeia (Ph. Eur.) online forum. The deadline for comments on the new monograph is 31 December 2021. This draft monograph is the outcome of a...
Pharmeuropa 33.4 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 33.4 is 31 December 2021. Users and interested parties are welcome to comment on these drafts. It should...
European Pharmacopoeia Supplement 10.7 now available
The European Pharmacopoeia (Ph. Eur.) Supplement 10.7 is now available and will be applicable in 39 European countries as of 1 April 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...
Publication of a new general chapter on balances in European Pharmacopoeia Supplement 10.6
At its 168th session (November 2020), the European Pharmacopoeia (Ph. Eur.) Commission adopted a new general chapter: Balances for analytical purposes (2.1.7). This new chapter is included in Supplement 10.6 of the Ph. Eur., published in July 2021. This addition to section 2.1. Apparatus fills a...
New publication on an EDQM Biological Standardisation Programme study for standardisation of allergen products
Following the successful completion of the BSP090 study on recombinant major allergens, in collaboration with project leaders from the Paul-Ehrlich-Institut, an article on one of the major study outcomes “Validation of a candidate European Pharmacopoeia standard method for quantification of major...
New monograph on a single-source anti-TNF-alpha monoclonal antibody released for public consultation in Pharmeuropa
A new draft monograph, Golimumab concentrated solution (3103), has been published in this quarter’s issue of Pharmeuropa (33.3), the European Pharmacopoeia (Ph. Eur.) online forum for comment. Following the adoption and publication of the monographs for Etanercept (2895) and Infliximab...
Revised general chapter 5.21 Chemometric methods applied to analytical data published for public comment in Pharmeuropa
The revised general chapter Chemometric methods applied to analytical data (5.21) has been published in this quarter’s issue of Pharmeuropa (33.3), the European Pharmacopoeia (Ph. Eur.) online forum, for comment. This general chapter, published for information, is an introduction to the use of...
Ph. Eur. Commission suspends the monograph on Gonadotrophin, equine serum, for veterinary use
The estimation of the potency of preparations covered by the Gonadotrophin, equine serum, for veterinary use (0719) monograph relies on comparative analyses performed with the WHO International Standard (IS) for equine serum gonadotrophin. The stocks of the IS for equine serum gonadotrophin are...
Pharmeuropa 33.3 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 33.3 is 30 September 2021. Users and interested parties are welcome to comment on these drafts. It...
Outcome of the 170th session of the European Pharmacopoeia Commission, June 2021
The European Pharmacopoeia (Ph. Eur.) Commission held its 170th session on 22 and 23 June 2021. As the decision-making body of the Ph. Eur., the Commission adopted 69 texts that will be published in Ph. Eur. Supplement 10.8 and be effective as of 1 July 2022. These 69 texts included the following...
Clostridium septicum vaccine antigen assays: new article available online in Pharmeuropa Bio & Scientific Notes
The outcome of Part 2 of the BSP130 collaborative study run under the common aegis of the European Partnership for Alternative Approaches to Animal Testing (EPAA) and the European Directorate for the Quality of Medicines & HealthCare (EDQM) Biological Standardisation Programme (BSP) has just been...
The Council of Europe appoints future EDQM Director
The Council of Europe has appointed Petra Dörr, PhD, as future Director of the European Directorate for the Quality of Medicines & HealthCare (EDQM). She will take over the function from the current Director, Susanne Keitel, in October 2021. Petra Dörr comes to the EDQM with more than 25 years of...
European Pharmacopoeia to put an end to the rabbit pyrogen test
At its 170th session in June 2021, the European Pharmacopoeia (Ph. Eur.) Commission took the decision to engage on a path that should ultimately lead to the complete replacement of the rabbit pyrogen test (RPT) in the Ph. Eur., within approximately 5 years. The Ph. Eur. test for pyrogens (general...
European Pharmacopoeia Supplement 10.6 now available
The European Pharmacopoeia (Ph. Eur.) Supplement 10.6 is now available and will be applicable in 39 European countries as of 1 January 2022. This volume is included in the 2022 subscription (10.6, 10.7 and 10.8) to the 10th Edition of the European Pharmacopoeia. Subscriptions for print and/or...
PDG’s efforts to engage other ICH pharmacopoeias in the Q4B Annexes maintenance process
At its November 2020 meeting, the ICH Assembly approved the proposal made by the PDG (Pharmacopoeial Discussion Group) on how to include the pharmacopoeias of the non-Founding ICH Regulatory Members in the maintenance of the ICH Q4B Annexes. The expansion of ICH membership provides an excellent...
New Pharmeuropa Bio & Scientific Notes article: Factor VIII BRP
An article on the successful outcome of a recent study of the Biological Standardisation Programme (BSP) of the European Directorate for the Quality of Medicines & HealthCare (EDQM) has been published in Pharmeuropa Bio & Scientific Notes, the EDQM’s free online journal. The study for the...