At its 170th session (June 2021), the European Pharmacopoeia Commission (EPC) agreed to elaborate a new general chapter, Phage therapy active substances and medicinal products for human and veterinary use (5.31), and assigned the task to the newly created Bacteriophages Working Party (BACT WP).

Phage therapy – the use of naturally occurring bacterial viruses (bacteriophages or phages) to treat bacterial infections – was first described in the early 20th century, but only remained in active use in a few countries. In recent years, however, phage therapy has regained the interest of physicians, researchers and industry as an attractive alternative to antibiotic treatment, particularly in the face of rising levels of antimicrobial resistance, increasingly frequent disruptions in antibiotic supply and an unmet demand for new antibiotics.

Addressing the quality of phage therapy has therefore been identified as a significant ongoing project for the EPC in the field of biologicals, and fulfilling the increasing expectations of users and being prepared for the future developments in this fast-moving field are amongst the EPC’s priorities for 2023-2025.

Elaborated by the BACT WP in response to these needs, the draft general chapter has now been published in Pharmeuropa 35.2, where it will remain open for public consultation from April until the end of June 2023. All interested parties are encouraged to review it and submit their comments. For more information on how to comment, please consult our guide.