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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 addressing the structural complexity and naturally occurring heterogeneity of these substances, and...

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.

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 parties and the scientific Secretariat, to ensure the continuity of the work of the Ph. Eur. was not...

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 for the quantification of endotoxins from gram-negative bacteria. The method described involves the...

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 32.2, this draft chapter covers elemental impurities that may be present in plastic materials used in...

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.).