Newsroom European Pharmacopoeia
Survey on strategy for Ph. Eur. quality standards for monoclonal antibodies
In 2014, the European Pharmacopoeia Commission (EPC) launched a pilot phase on setting public standards for therapeutic monoclonal antibodies (mAbs) (“MAB pilot phase”). This pilot phase was intended to explore the feasibility of establishing individual monographs for multi-source mAbs, as well...
EDQM’s ISO 9001:2015 certification maintained
The European Directorate for the Quality of Medicines & HealthCare’s (EDQM) ISO 9001:2015 certificate has been maintained following the second surveillance audit of its quality management system on 28 and 29 November 2023 by the official French standardisation body Association française de...
Save the date: EDQM conference celebrating 60 years of excellence in public health protection
In 2024, the European Directorate for the Quality of Medicines & HealthCare (EDQM) is celebrating 60 years of excellence in the protection and promotion of public health. We are delighted to announce the organisation of a conference to mark this occasion, on 11 and 12 June 2024, in Strasbourg...
Ph. Eur. progress in the field of homoeopathic manufacturing methods
The European Directorate for the Quality of Medicines & HealthCare (EDQM) is proud to highlight the remarkable progress made in 2023 on European Pharmacopoeia (Ph. Eur.) texts on homoeopathic manufacturing methods, with the recent publication (January 2024) of three revised general monographs in...
New strategy for N-nitrosamine impurities in Ph. Eur. monographs
At its 177th session in November 2023, the European Pharmacopoeia Commission (EPC) approved the strategy for N-nitrosamine impurities in individual monographs. Regarding active substances The EPC agreed to delete the Production section covering N-nitrosamine impurities from existing individual...
Pharmeuropa 36.1 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 36.1 is 31 March 2024. Users and interested parties are welcome to comment on these drafts. It should be...
New general chapter on comparability of alternative analytical procedures published in European Pharmacopoeia
A new general chapter, Comparability of alternative analytical procedures (5.27), has been published in Supplement 11.5 of the European Pharmacopoeia (Ph. Eur.). The text was adopted by the European Pharmacopoeia Commission at its 176th session in June 2023. This new general chapter describes how...
General chapters on powder characterisation techniques modernised
The European Directorate for the Quality of Medicines & HealthCare (EDQM) is proud to highlight the remarkable progress made in 2023 on five general chapters of the European Pharmacopoeia (Ph. Eur.) that cover procedures for powder characterisation. The three revised and two newly elaborated...
European Pharmacopoeia Supplement 11.5 now available
The European Pharmacopoeia (Ph. Eur.) Supplement 11.5 is now available and will be applicable in 39 European countries as of 1 July 2024. This volume is included in the 2024 subscription (11.3, 11.4 and 11.5) to the 11th Edition of the Ph. Eur. Subscriptions for print and/or electronic versions...
European Pharmacopoeia welcomes Egyptian Drug Authority as observer
The Egyptian Drug Authority has been granted observer status to the European Pharmacopoeia Commission (EPC). This decision demonstrates the dynamism of the European Pharmacopoeia (Ph. Eur.), which now has 33 observers from around the world in addition to 39 European countries and the European...
Outcome of the 177th session of the European Pharmacopoeia Commission, November 2023
The European Pharmacopoeia Commission (EPC) held its 177th session on 21 and 22 November 2023. The EPC adopted 77 texts at this session, to be published in European Pharmacopoeia (Ph. Eur.) Supplement 11.6 (July 2024) and be effective as of 1 January 2025. These 77 texts included nine new...
Ph. Eur. pre-publishes revised Propylene glycol monograph
The revised monograph on Propylene glycol (0430) was adopted by the European Pharmacopoeia Commission (EPC) at its 177th session held on 21 and 22 November 2023. The monograph was revised in response to the public health risk posed by the discovery of ethylene glycol (EG) and diethylene glycol...
European Paediatric Formulary: Flecainide acetate oral solution and Valaciclovir oral solution monographs in public consultation
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just released Issue 8 of Pharmeuropa PaedForm. The experts of the PaedF working party are glad to publish the ninth and tenth monographs for public consultation, Flecainide acetate 10 mg/mL oral solution and...
2024 EDQM virtual training programme: Ph. Eur. texts related to biologicals and microbiology chapters
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has opened registration for its 2024 virtual training programme, composed of four independent modules on European Pharmacopoeia (Ph. Eur.) texts related to biologicals and on microbiology chapters. Get full information on...
Pharmacopoeial Discussion Group Achievements
The Pharmacopoeial Discussion Group (PDG) held its annual autumn meeting from 3 to 4 October 2023. The group welcomed the Indian Pharmacopoeia Commission (IPC) as a new member during the meeting (link). The addition of the IPC, a first in the over 34-year history of the PDG, facilitates the reach...
EDQM joins efforts to tackle medicine shortages
Medicine shortages are a growing problem that compromises patient care. Two key committees at the European Directorate for the Quality of Medicines & HealthCare (EDQM), the European Committee on Pharmaceuticals and Pharmaceutical Care (CD-P-PH) and the European Pharmacopoeia Commission (EPC), are...
Revised general chapter 2.7.24 Flow cytometry in Pharmeuropa 35.4
The European Pharmacopoeia (Ph. Eur.) is seeking stakeholder feedback on the revised general chapter Flow cytometry (2.7.24), published in this quarter’s issue of Pharmeuropa (35.4) for comment (public deadline 31 December 2023). The revision of this general chapter is of high importance since it...
Pharmacopoeial Discussion Group welcomes Indian Pharmacopoeia Commission as a member, facilitating reach and enhancing impact of pharmacopoeial standards harmonisation
The Pharmacopoeial Discussion Group (PDG) today announced the Indian Pharmacopoeia Commission (IPC) as a PDG member.
Ph. Eur. pre-publishes Cannabis flower monograph on the EDQM website
The new monograph on Cannabis flower (3028) was adopted at the 176th session of the European Pharmacopoeia (Ph. Eur.) Commission held on 20 and 21 June 2023. Given the exceptionally high interest from stakeholders in having access to the new text as soon as possible, the Ph. Eur. decided to make...
Pharmeuropa 35.4 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 35.4 is 31 December 2023. Users and interested parties are welcome to comment on these drafts. It should...