Focus group meeting on bacteriophages as veterinary medicines
Table of contents
There is increasing interest in the use and promotion of bacteriophage therapy in particular because of its potential to reduce the use of antibiotics. Phage therapies are considered novel therapies under Regulation (EU) 2019/6 and therefore require marketing authorisation through the centralised procedure.
The Novel Therapies and Technologies Working Party (NTWP) has drafted a guideline on the quality, safety, and efficacy requirements for this product class. The guideline focuses on the establishment of a suitable regulatory framework for bacteriophage products to encourage development of these innovative therapies.
The Agency, in collaboration with the NTWP, is organising a Focus Group meeting on 11 May 2023, to discuss the draft bacteriophages guideline before the public consultation period ends on 31 May 2023.
Developers of bacteriophages technology are invited to express their interest in attending the Focus Group meeting via NTWP@ema.europa.eu.
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Focus Group Meeting on Bacteriophages - Programme (11 May 2023) (PDF/121.28 KB) (updated)
First published: 28/04/2023
Last updated: 10/05/2023 -
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Presentation - Bacteriophages - activities of the European Pharmacopoeia (Olga Kolaj-Robin) (PDF/3.13 MB) (new)
First published: 26/05/2023 -
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Presentation - Case studies on the Guideline on quality, safey and efficacy of veterinary medicinal products specifically designed for phage therapy (Frederic Klein) (PDF/599.36 KB) (new)
First published: 26/05/2023 -
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Presentation - Case study on a VMP with flexible composition to treat diarrhea caused by ETEC in post-weaning piglets (Susana Casado) (PDF/932.51 KB) (new)
First published: 26/05/2023 -
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Presentation - Draft Guideline on quality, safety and efficacy of veterinary medicinal products specifically designed for phage therapy (efficacy part) (Belén Gutiérrez) (PDF/711.66 KB) (new)
First published: 26/05/2023 -
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Presentation - Draft Guideline on quality, safey and efficacy of veterinary medicinal products specifically designed for phage therapy (quality part) (Martin B. Oleksiewicz) (PDF/528.25 KB) (new)
First published: 26/05/2023 -
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Presentation - Draft Guideline on quality, safey and efficacy of veterinary medicinal products specifically designed for phage therapy (safey part) (Sandra-Maria Wienhold) (PDF/311.21 KB) (new)
First published: 26/05/2023 -
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Presentation - Setting the scene introduction on the background and expected outputs for the meeting (Susana Casado) (PDF/1.45 MB) (new)
First published: 26/05/2023