The European Pharmacopoeia (Ph. Eur.) Commission held its 172nd session on 22 and 23 March 2022. The Commission adopted 78 texts at this session, to be published in Ph. Eur. Supplement 11.1 and be effective as of 1 April 2023.
These 78 texts included six new monographs and one new general chapter:
- monographs on Berberis aristata stem (2851) and Rhubarb dry extract, standardised (1845) ;
- two traditional Chinese medicine monographs: Saposhnikovia root (2728) and Pulsatilla root (2972) ;
- a monograph on Valganciclovir hydrochloride (2930) ;
- a monograph on Fulvestrant injection (3096), the second on a medicinal product containing a chemically defined active substance elaborated under the P1 procedure (multi-source products);
- a general chapter entitled Cell-based assay for potency determination of TNF-alpha antagonists (2.7.26), together with revised versions of the monographs on Infliximab, concentrated solution (2928) and on Etanercept (2895) ; this topic will be the subject of a separate news item on the European Directorate for the Quality of Medicines & HealthCare (EDQM) website.
For more information, read the press release “Outcome of the 172nd session of the European Pharmacopoeia Commission, March 2022”.