ArticleViruses2024
The Medicinal Phage-Regulatory Roadmap for Phage Therapy under EU Pharmaceutical Legislation.
Article in Viruses, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 38 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
38 citing papers in PubMed, 1 synthesis or guideline pooled it, 52 citations in OpenAlex.
- Precision phage therapy in the AI/ML era: a systematic review of discovery-to-clinical translation evidence.Frontiers in microbiology · 2026Pooled it
- From laboratory to clinical application: a narrative review of bacteriophage therapy for antimicrobial-resistant infections in veterinary medicine.Veterinary research communications · 2026Review
- Review
- Bacteriophage therapy for antimicrobial-resistant, biofilm‑associated diabetic foot infection: delivery routes, phage antibiotic synergy, and practical wound‑care integration.Archives of microbiology · 2026Review
- Isolation, Characterization, and In Vivo Evaluation Efficacy of Lytic Bacteriophage SEP1 AgainstViruses · 2026Article
- Insight into Bacteriophage Therapy for Bacterial Infections and Cancer.Molecular biotechnology · 2026Review
- Review
- The Combat Against Antimicrobial Resistance: An Overview of EU Recent Health Policies and Drug Regulations Promoting the Development of New Antimicrobials.Pharmaceutical medicine · 2026Review
- Review
- Antimicrobial Resistance: Italian and American Efforts to Counter it.The AAPS journal · 2026Article
- Phage Therapy at the Crossroads Between Clinical Promise and Regulatory Challenge.Pharmaceuticals (Basel, Switzerland) · 2026Review
- Phage cocktails: state-of-the-art technologies and strategies for effective design.FEMS microbiology reviews · 2026Review
- Antibacterial Immunotherapy: Mechanistic Insights, Emerging Therapeutic Strategies, and Clinical Translation.Infection and drug resistance · 2026Review
- Navigating Regulatory Frameworks and Compliances for Bacteriophages as Therapeutic Agents.Current pharmaceutical biotechnology · 2026Review
- Application of bacteriophages in the prevention and control of bacterial infectious diseases in animals.Frontiers in microbiology · 2026Review
- Antimicrobial Peptides Against Antimicrobial-Resistant Bacteria: Focus on Machine Learning.Infection and drug resistance · 2026Review
- Searching for the perfect match: can non-antibiotic antimicrobials improve bacteriophage performance?Frontiers in cellular and infection microbiology · 2026Review
- Preventive Immunology for Livestock and Zoonotic Infectious Diseases in the One Health Era: From Mechanistic Insights to Innovative Interventions.Veterinary sciences · 2025Review
- Phage to ESKAPE: Personalizing Therapy for MDR Infections-A Comprehensive Clinical Review.Pathogens (Basel, Switzerland) · 2025Review
- Emerging Challenges inPathogens (Basel, Switzerland) · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
1 author at 1 institution in 1 country.
Funding
Abstract
Bacteriophage therapy is a promising approach to treating bacterial infections. Research and development of bacteriophage therapy is intensifying due to the increase in antibiotic resistance and the faltering development of new antibiotics. Bacteriophage therapy uses bacteriophages (phages), i.e., prokaryotic viruses, to specifically target and kill pathogenic bacteria. The legal handling of this type of therapy raises several questions. These include whether phage therapeutics belong to a specially regulated class of medicinal products, and which legal framework should be followed with regard to the various technical ways in which phage therapeutics can be manufactured and administered. The article shows to which class of medicinal products phage therapeutics from wild type phages and from genetically modified (designer) phages do or do not belong. Furthermore, the article explains which legal framework is relevant for the manufacture and administration of phage therapeutics, which are manufactured in advance in a uniform, patient-independent manner, and for tailor-made patient-specific phage therapeutics. For the systematically coherent, successful translation of phage therapy, the article considers pharmaceutical law and related legal areas, such as genetic engineering law. Finally, the article shows how the planned legislative revisions of Directive 2001/83/EC and Regulation (EC) No 726/2004 may affect the legal future of phage therapy.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.