Quality aspects of phage therapy medicinal products
HumanRegulatory and procedural guidanceMedicinesScientific adviceScientific guidelines
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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.
Keywords: Guideline, Bacteriophage, Phage Therapy, Development and Manufacture, Active Substance, Finished Product, Antimicrobial Resistance