PhageEU has published its position with regards to the Pharmaceutical Package.
With its recommendations for decision makers, PhageEU aims at making sure, that phage therapies are recognised within key areas of pharmaceutical legislation like antimicrobial incentives, regulatory flexibility, and streamlined approval pathways.
Specifically, PhageEU is calling on EU legislators to:
- Introduce a new definition for bacteriophages and expand the definition of antimicrobials,
- Include phages in Priority Antimicrobial Incentives & Transferable Rights,
- Establish Regulatory Sandboxes for phage therapies,
- Create streamlined phage cocktail updates.
Given the urgent need for antibiotic alternatives, PhageEU sees its targeted amendments to the Pharmaceutical Package as a practical way to integrate phages into the EU regulatory framework and make the Pharmaceutical Package fit for future developments.
Phage EU is a coalition of likeminded stakeholders who represent phages in industry, the scientific community and civil society. We want to realize the full potential of phages in Europe.
Media Contact and Secretariat
Margareta Przybyla
PhageEU Secretary General
Contact Details
mprzybyla@phageurope.eu
Tel: 0032 476 591 091