Phage Therapy Approved in Portugal: Deliberation No. 112/CD/2024

As antibiotic resistance intensifies and becomes an increasing threat to global public health, interest is growing in alternative therapies that are both safe and effective. It is within this context that bacteriophages emerge.

Bacteriophages, or simply phages, are natural or modified viruses that target only specific bacterial strains. This high specificity makes them particularly promising in the fight against infections resistant to conventional antibiotics. In clinical settings, therapeutic products based on bacteriophages, known as Phage Therapy Medicinal Products (PTMPs), may contain one or more phages combined with excipients and formulated for different routes of administration.

What does European regulation say?
Despite their potential, phage therapy still lacks a regulatory framework in the European Union that is fully adapted to its specific nature. The European Medicines Agency currently classifies these products as medicinal products.
Although there is not yet dedicated European legislation for the use of bacteriophages in humans, efforts are underway in this direction:
• The publication of General Chapter 5.31 of the European Pharmacopoeia, which sets quality standards applicable to PTMPs;
• The EMA’s draft guideline on the development and manufacture of phage therapy medicinal products, currently in the Concept Paper stage;
• Belgium’s pioneering example with its Magistral Phage Framework, which allows for the individualized preparation of phage-based products in hospital pharmacies.

Phage Therapy Approved in Portugal

Portugal recently took a decisive step by establishing a national regulatory framework for the hospital use of bacteriophages. Deliberation No. 112/CD/2024, published by INFARMED, I.P. on November 15, 2024, defines the conditions under which these products may be used in a clinical setting, as magistral preparations.

This decision stems from the growing need for effective alternative solutions to treat resistant infections, while ensuring the safety, quality, and monitoring of these treatments. Accordingly:
• Bacteriophages can be used in specific cases, outside the traditional marketing authorization route;
• Their preparation must follow strict quality criteria;
• Ongoing monitoring of their clinical use is required, including data on efficacy, adverse events, and patient response.

With this measure, Portugal joins other pioneering European countries in recognizing bacteriophages as a valid therapeutic option, provided their use is properly controlled and clinically justified.