The article "The Medicinal Phage—Regulatory Roadmap for Phage Therapy under EU Pharmaceutical Legislation" by Timo Faltus explores the legal and regulatory landscape of bacteriophage therapy, a promising approach to treating bacterial infections. The author discusses the challenges and questions surrounding the classification of phage therapeutics as medicinal products, the legal framework for their manufacture and administration, and the potential impact of legislative revisions on their future. Key points include: 1. **Legal Classification**: The article examines whether phage therapeutics, whether from wild-type or genetically modified (designer) phages, belong to a specially regulated class of medicinal products. 2. **Manufacture and Administration**: It explains the relevant legal frameworks for the uniform, patient-independent production of phage therapeutics and for tailor-made, patient-specific treatments. 3. **Phage Therapy Mechanism**: The article clarifies that phage therapy has a pharmacological effect, as it interacts with bacterial receptors and results in a direct reaction, unlike immunological or metabolic effects. 4. **Application Settings**: Phage therapy can be either a pre-made, uniform product or a patient-specific, individualized treatment. The article discusses the organizational and technical aspects of each setting. 5. **Regulatory Considerations**: The article addresses whether phages are pharmaceutical substances, active substances, or medicinal products, and how they relate to other classes such as cells, tissues, blood products, xenogeneic products, immunological products, biocides, and medical devices. 6. **Genetically Modified Phages**: It explores the legal classification of genetically modified phages, including whether they are genetically modified organisms (GMOs) or genetically modified microorganisms (GMMs), and their potential classification as gene therapy medicinal products (GTMPs). 7. **Future Legislative Revisions**: The article considers how planned legislative revisions to Directive 2001/83/EC and Regulation (EC) No 726/2004 might affect the legal future of phage therapy. Overall, the article provides a comprehensive overview of the legal and regulatory challenges and opportunities for phage therapy, aiming to facilitate interdisciplinary discussions between scientists, physicians, lawyers, and regulators.The article "The Medicinal Phage—Regulatory Roadmap for Phage Therapy under EU Pharmaceutical Legislation" by Timo Faltus explores the legal and regulatory landscape of bacteriophage therapy, a promising approach to treating bacterial infections. The author discusses the challenges and questions surrounding the classification of phage therapeutics as medicinal products, the legal framework for their manufacture and administration, and the potential impact of legislative revisions on their future. Key points include: 1. **Legal Classification**: The article examines whether phage therapeutics, whether from wild-type or genetically modified (designer) phages, belong to a specially regulated class of medicinal products. 2. **Manufacture and Administration**: It explains the relevant legal frameworks for the uniform, patient-independent production of phage therapeutics and for tailor-made, patient-specific treatments. 3. **Phage Therapy Mechanism**: The article clarifies that phage therapy has a pharmacological effect, as it interacts with bacterial receptors and results in a direct reaction, unlike immunological or metabolic effects. 4. **Application Settings**: Phage therapy can be either a pre-made, uniform product or a patient-specific, individualized treatment. The article discusses the organizational and technical aspects of each setting. 5. **Regulatory Considerations**: The article addresses whether phages are pharmaceutical substances, active substances, or medicinal products, and how they relate to other classes such as cells, tissues, blood products, xenogeneic products, immunological products, biocides, and medical devices. 6. **Genetically Modified Phages**: It explores the legal classification of genetically modified phages, including whether they are genetically modified organisms (GMOs) or genetically modified microorganisms (GMMs), and their potential classification as gene therapy medicinal products (GTMPs). 7. **Future Legislative Revisions**: The article considers how planned legislative revisions to Directive 2001/83/EC and Regulation (EC) No 726/2004 might affect the legal future of phage therapy. Overall, the article provides a comprehensive overview of the legal and regulatory challenges and opportunities for phage therapy, aiming to facilitate interdisciplinary discussions between scientists, physicians, lawyers, and regulators.