Focus group meeting on bacteriophages as veterinary medicines

• Date:
  Thursday, 11 May 2023, 09:30 - 16:30 Amsterdam time (CEST)
• Location:
  Online
  European Medicines Agency, Amsterdam, the Netherlands

Event summary

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 [e-mail].

Documents

Focus Group Meeting on Bacteriophages - Programme (11 May 2023)

Presentation - Bacteriophages - activities of the European Pharmacopoeia (Olga Kolaj-Robin)

Presentation - Case studies on the Guideline on quality, safey and efficacy of veterinary medicinal products specifically designed for phage therapy (Frederic Klein)

Presentation - Case study on a VMP with flexible composition to treat diarrhea caused by ETEC in post-weaning piglets (Susana Casado)

Presentation - Draft Guideline on quality, safety and efficacy of veterinary medicinal products specifically designed for phage therapy (efficacy part) (Belén Gutiérrez)

Presentation - Draft Guideline on quality, safey and efficacy of veterinary medicinal products specifically designed for phage therapy (quality part) (Martin B. Oleksiewicz)

Presentation - Draft Guideline on quality, safey and efficacy of veterinary medicinal products specifically designed for phage therapy (safey part) (Sandra-Maria Wienhold)

Presentation - Setting the scene introduction on the background and expected outputs for the meeting (Susana Casado)

Video recording