New general chapter on Phage therapy medicinal products (5.31) adopted and pre-published on the EDQM website
Rising levels of antimicrobial resistance in recent years, identified as one of the leading threats to global public health and development, have prompted renewed interest in the use of phage therapy for the treatment of bacterial infections. This led the European Pharmacopoeia Commission (EPC)...
Ph. Eur. bids adieu to rabbit pyrogen test in its monographs
Pyrogen detection is essential for ensuring the safety of parenteral medicines. For decades, the rabbit pyrogen test (RPT) has been the traditional method. The RPT involves measuring the rise in body temperature in rabbits following intravenous injection of the substance to be examined. Despite...
New European Pharmacopoeia Commission approach to gene therapy
General chapter 5.14. Gene transfer medicinal products for human use was first published in European Pharmacopoeia (Ph. Eur.) Supplement 5.6 in 2006, when there were no approved gene therapy medicinal products (GTMPs) on the European market. Several GTMPs have since been approved and an...
Outcome of the 179th session of the European Pharmacopoeia Commission, June 2024
The European Pharmacopoeia Commission (EPC) held its 179th session on 18 and 19 June 2024. A summary of its outcome is available in the infographic below. Highlights will be published shortly on our website and the full list of adopted texts will be made available on the Ph. Eur. Work Programme...
Critical medicine shortages - immediate workflow and trial phase with two ongoing shortages
Download The task of the European Drug Shortages Formulary Working Party (EDSForm WP), created at the end of November 2023, is to define both short-term and long-term actions aimed at mitigating the negative impact of medicine shortages on public health. Short-term actions involve compiling...
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