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EMA – Public consultation: Draft guideline on quality aspects of phage therapy medicinal products

The aim of this guideline is to clarify the regulatory expectations for quality documentation of bacteriophage active substances and finished products for human use within marketing authorisation applications. It addresses specific aspects regarding the manufacture, control of materials, characterisation, specifications, analytical control, reference standards and stability of bacteriophage active substances. In addition, guidance is given on the pharmaceutical development, manufacture, control and stability of the finished product.

The draft guideline can be found on the dedicated page on the EMA Website.

The deadline for comments is 30 April 2026. Templates and other open consultations can be found on the EMA Website.


OpenEdition vous propose de citer ce billet de la manière suivante :
vroby (11 décembre 2025). EMA – Public consultation: Draft guideline on quality aspects of phage therapy medicinal products. ELSIBI. Consulté le 16 mars 2026 à l’adresse https://doi.org/10.58079/15buu


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