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European Pharmacopoeia / Monograph | News | 20 January 2022 | Strasbourg, France
This document is intended to help stakeholders understand the advantages of applying for a monograph elaboration via European Pharmacopoeia (Ph. Eur.) 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 Party.
European Pharmacopoeia / Monograph | News | 13 January 2022 | Strasbourg, France
Sterility requirements in non-liquid and non-parenterally administered veterinary vaccine monographs have been replaced by a maximum bioburden limit to allow the development of new innovative vaccine presentation forms while maintaining the same safety guarantees.
European Pharmacopoeia / Public enquiry | News | 10 January 2022 | Strasbourg, France
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 (deadline 31 March 2022).
European Pharmacopoeia / Public enquiry | News | 05 January 2022 | Strasbourg, France
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.
EDQM | News | 21 December 2021 | Strasbourg, France
Applications: please send your CV and motivation letter in French to: hr@edqm.eu by 14 January 2022 the latest.
News | 15 December 2021 | Strasbourg, France
The European Pharmacopoeia (Ph. Eur.) Supplement 10.8 is now available and will be applicable in 39 European countries as of 1 July 2022.
European Pharmacopoeia / Monograph | News | 15 November 2021 | Strasbourg, France
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 will be held from 19 to 21 September 2022, in Strasbourg (France), if the pandemic situation allows...
EDQM / Quality Management system | News | 15 November 2021 | Strasbourg, France
The European Directorate for the Quality of Medicines & HealthCare (EDQM) Laboratory successfully obtained the renewal of its accreditation according to the ISO/IEC 17025:2017 standard in October 2021 from the Belgian accreditation organisation BELAC, confirming the validity of the results generated for its European Pharmacopoeia reference standards. The accreditation scope covers 21...
European Pharmacopoeia / International harmonisation | News | 08 November 2021 | Strasbourg, France
The harmonised general chapter Chromatography was signed-off by the Pharmacopoeial Discussion Group (PDG), which brings together the European Pharmacopoeia (Ph. Eur.), Japanese Pharmacopoeia (JP) and the United States Pharmacopeia (USP), on 28 September 2021. The coordinating pharmacopoeia for this text was the Ph. Eur.
European Pharmacopoeia / International harmonisation | News | 18 October 2021 | Strasbourg, France
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 pharmacopoeias. This is a critical step in the PDG’s commitment to expanding recognition of harmonised...
European Pharmacopoeia / General | News | 15 October 2021 | Strasbourg, France
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.
European Pharmacopoeia / Monograph | News | 14 October 2021 | Strasbourg, France
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).
European Pharmacopoeia / Monograph | News | 06 October 2021 | Strasbourg, France
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.
European Pharmacopoeia / Public enquiry | News | 05 October 2021 | Strasbourg, France
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.
European Pharmacopoeia / Monograph | News | 04 October 2021 | Strasbourg, France
The European Pharmacopoeia (Ph. Eur.) Supplement 10.7 is now available and will be applicable in 39 European countries as of 1 April 2022.