Mystic Community Church Group

The regulatory landscape for bacteriophage products in Europe is evolving to accommodate the growing interest in phage therapy and biocontrol applications. In April 2023, the European Commission proposed a new Directive on medicinal products for human use, which includes provisions for phage-containing medicinal products. This proposal aims to harmonize the regulatory framework across EU member states, ensuring the safety and efficacy of phage-based therapies.

Furthermore, the European Pharmacopoeia Commission published a General Chapter on "Phage therapy active substances and medicinal products for human and veterinary use" in Pharmeuropa 35.2. This publication provides guidelines for the production and quality control of phage Active Pharmaceutical Ingredients, standardizing practices across the region.

These regulatory developments are expected to accelerate the approval process for phage-based products, fostering innovation and investment in the European bacteriophage market.