EMA to Hold Major Workshop on the Future EU Framework for Phage Therapy

The European Medicines Agency will convene a major workshop dedicated to bacteriophage therapy on 30 October 2026, bringing together European and international regulators, scientists, clinicians, developers, healthcare professionals and patient representatives.

Held at EMA headquarters in Amsterdam and simultaneously accessible online, the meeting will focus on one of the most persistent obstacles to the wider clinical development of phage therapy in Europe: how to regulate a treatment whose composition may need to change according to the bacterial strain infecting an individual patient.

Bacteriophages do not always fit comfortably within the conventional pharmaceutical model. Most medicines are developed around an active substance and composition that remain well defined throughout development and after authorization. Personalized phage therapy can operate very differently. A patient's bacterial isolate may need to be tested against a library of phages, one or several matching viruses selected, and those components potentially replaced if resistance emerges or if the bacterial population changes.

This adaptability is one of phage therapy's potential strengths, but it also creates difficult regulatory questions involving manufacturing, quality control, susceptibility testing, traceability, pharmacovigilance and authorization.

Several European countries have already developed national mechanisms allowing access to phage therapy outside conventional marketing authorizations. However, these approaches remain heterogeneous. The EMA workshop is intended to examine whether a more coherent framework could be developed at European level while maintaining pharmaceutical standards for quality, safety and clinical evidence.

The timing of the meeting is particularly significant. The European Union is simultaneously completing a broad reform of its pharmaceutical legislation. The Council formally adopted the pharmaceutical package on 28 September 2026; the legislation still requires adoption by the European Parliament and publication in the Official Journal before entering into force.

According to the workshop programme, the opening discussions will examine the existing European regulatory landscape and its structural gaps.

Belgium will be one of the central examples. Representatives from the Queen Astrid Military Hospital and the Belgian Federal Agency for Medicines and Health Products will discuss mechanisms including magistral preparation, hospital exemption and the Belgian framework for magistrally prepared phages.

France will also have a substantial role through the ANSM and the PHAGEinLYON clinical programme. The programme at Hôpital de la Croix-Rousse and CRIOAc Lyon is expected to present experience involving compassionate access, multidisciplinary case management, interaction with the French regulatory authority and clinical management of complex bone and joint infections.

This real-world experience is particularly relevant because the regulatory debate is no longer purely theoretical. European physicians and specialized centres have already used individualized phage preparations in difficult clinical cases, creating practical experience with phage matching, manufacturing, administration and regulatory oversight.

The European Commission and EMA will subsequently examine what the programme describes as new tools under an adapted regulatory framework. This includes delegated and implementing acts under the revised European pharmaceutical legislation and the role of the centralized authorization procedure.

The scientific requirements behind such a system will occupy a large part of the workshop.

One session led by Sciensano will focus on phage biology and quality characterization. Host range, stability and manufacturing variability are specifically identified as areas where phages can challenge conventional pharmaceutical approaches.

This is an important distinction. For a conventional drug, chemical identity and concentration may provide much of the information required to characterize the active substance. For a phage, biological activity also depends on its capacity to recognize, infect and replicate within particular bacterial strains.

A phage preparation can therefore be perfectly intact from a physicochemical perspective while being clinically irrelevant if the patient's pathogen is resistant to it.

This brings phage susceptibility testing to the centre of the regulatory discussion.

The EUCAST Phage Susceptibility Testing Subcommittee, Hospices Civils de Lyon and Université de Lyon will present ongoing work toward standardizing phage susceptibility testing. The session will cover reference methods, interpretation of phagograms, quality assurance and the regulatory implications of using susceptibility results to select therapeutic phages.

Standardization in this area could become crucial for routine clinical use. If a treatment is selected according to the result of a phagogram, laboratories need reproducible methods capable of distinguishing meaningful susceptibility from weak or uncertain activity.

Without such standards, two laboratories could theoretically evaluate the same phage-bacterium combination and reach different conclusions about whether a phage should be used.

Another major topic will be engineered bacteriophages.

The European Commission will discuss environmental risk assessment and the GMO status of engineered phage products. The agenda specifically includes environmental release of self-replicating biological agents, contained-use versus deliberate-release considerations and simplified GMO procedures for clinical trials.

These questions could become increasingly important as synthetic biology makes it possible to alter phage host range, remove undesirable genes, add new antibacterial functions or otherwise engineer phages for therapeutic applications.

Clinical development will also be examined from a perspective adapted to the unusual characteristics of phage therapy.

Hadassah-Hebrew University Medical Center will present an academic perspective combining evidence generated outside conventional clinical trials with possible platform trial designs. The programme also mentions paediatric development, including potential applications in cystic fibrosis and neonatal sepsis.

One of the most consequential discussions of the day is likely to concern platform authorization and master-file concepts for phage libraries.

Traditional pharmaceutical regulation often evaluates a medicinal product according to its defined composition. But personalized phage therapy could instead rely on a library containing many previously characterized phages, from which different combinations are selected according to the patient's bacterial isolate.

The workshop will examine whether regulators could move beyond a strictly product-by-product approach by defining fixed and variable components within a larger authorized platform.

Such a system could potentially allow the therapeutic composition to evolve without requiring the entire regulatory process to restart every time a phage is exchanged.

However, that flexibility would create its own requirements. Regulators would still need mechanisms ensuring that every phage entering the platform has been sufficiently characterized, manufactured to appropriate standards and properly tracked.

Lifecycle management, pharmacovigilance and traceability are therefore explicitly included in the agenda.

The discussion builds on work that EMA has already undertaken on pharmaceutical quality. Its guideline on quality aspects of phage therapy medicinal products addresses the manufacture and characterization of bacteriophage active substances, analytical controls, specifications, reference standards, stability and the development of finished products. The public consultation on the draft guideline ran from October 2025 until 30 April 2026.

The guideline recognizes both single-phage products and preparations containing several different phages, generally referred to as multiphage products or phage cocktails. It also addresses issues such as potency, formulation and stability that will remain important regardless of how flexible the future regulatory framework becomes.

The workshop will also compare European discussions with approaches outside the EU.

Representatives from the US Food and Drug Administration and Health Canada are scheduled to participate in a joint session. The US discussion will include biologics classification, Investigational New Drug pathways and single-patient expanded access. The Canadian contribution will include clinical phage microbiology, the Phage Canada model and regulatory engagement.

Rather than simply copying another jurisdiction's system, the objective is to identify elements that could inform a European approach.

Manufacturing represents another major obstacle to scalability.

Industry representatives from Jafral, Phage Europe, 5QBD Biotech and BEAM-Phage ACT will address GMP production, scale-up, batch consistency and the regulatory challenges associated with bespoke phage preparations.

These questions are particularly difficult for personalized therapy because conventional pharmaceutical manufacturing is optimized around producing large, reproducible batches of an unchanged product.

A personalized phage platform may instead need to produce or combine different biological components relatively rapidly while maintaining appropriate controls over sterility, identity, potency and contaminants.

Later in the afternoon, EMA and Belgian regulators will specifically discuss adaptive phage preparation and GMP considerations, including bespoke manufacturing, hospital-based production and proportionate quality requirements.

The concept of proportionality may prove particularly important. A regulatory framework must ensure that phage preparations administered to patients meet appropriate quality standards, but requirements also need to account for circumstances in which preparations are individualized or produced in relatively small quantities.

The final sessions will bring these elements together.

Regulators and participants will discuss potential principles for an adapted European phage therapy framework, remaining areas of disagreement, patient access, health technology assessment and a roadmap for future regulatory development.

An open discussion involving all participants is scheduled before the EMA closes the meeting with proposed next steps. The Agency also intends to publish a report following the workshop.

The meeting should therefore not be interpreted as the immediate creation of a European authorization pathway for phage therapy.

Its significance is that many of the problems that have historically been addressed separately are now being considered together: susceptibility testing, clinical evidence, personalized selection, phage libraries, changing compositions, GMP manufacturing, compassionate use, engineered phages, quality requirements and international regulatory experience.

Together, these issues determine whether phage therapy can move from exceptional and highly individualized access toward a reproducible pharmaceutical framework.

The central regulatory challenge will be maintaining standards without removing the biological flexibility that distinguishes phages from conventional medicines.

A framework that is too rigid could make rapid personalization nearly impossible. A framework that is too permissive could create unacceptable variability in quality, manufacturing or clinical evidence.

The 30 October meeting is therefore less about deciding whether phage therapy should be regulated and more about determining what an appropriate regulatory system for a dynamic biological therapy should actually look like.

For the European phage community, that makes this workshop an important event to follow.

The EMA Workshop on Bacteriophage Therapy will take place on Friday, 30 October 2026, from 09:00 to 18:00 CET, at the European Medicines Agency in Amsterdam and online. In-person participation is by invitation, while online participation is available through registration.