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) to make the elaboration of European Pharmacopoeia (Ph. Eur.) texts standardising requirements for phage therapy one of its top priorities for the years 2023-2025.

Phage therapy medicinal products (5.31), the first such text, was adopted by the EPC at its 178th session held on 19 and 20 March 2024. This new general chapter provides a framework of requirements for the production and control of phage therapy products and allows a degree of flexibility commensurate with the complex approaches currently employed in this emerging and rapidly developing field.

Phage therapy medicinal products is the first up-to-date text of its kind to be published in a pharmacopoeia and, given the high interest in the subject matter for the reasons described above, the EPC also decided to exceptionally pre-publish the text on the website of the European Directorate for the Quality of Medicines & HealthCare (EDQM) pending its publication in Supplement 11.6 (July 2024).

The Ph. Eur. Bacteriophage Working Party will now focus its efforts on elaborating the general chapter on bacteriophage potency determination that was added to the work programme at the 176th EPC session in June 2023.

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