Comparing regulatory statuses and guidance by region.
| Region | Current access pathway(s) emphasized | Key 2024–2026 updates | Implications for clinical development and research |
|---|---|---|---|
| European Union | Pharmacopeial standards + evolving EMA guidance; national pathways vary | Ph. Eur. 5.31 framework for production/control; EMA draft quality guideline with consultation through Apr 30, 2026 | Supports harmonized quality language; still requires clear clinical trial pathways and comparability methods for updates. |
| UK | Biological medicine classification; IMP clinical trials; “specials” for unlicensed supply | MHRA regulatory considerations document (Nov 2025) + industry-facing guidance; “no MA granted” statement at publication | Clearer navigation for developers highlights that licensing evidence standards remain unmet and that “specials” transfer liability to prescribers. |
| US | IND development + expanded access | FDA expanded access criteria and submission guidance maintained/updated; IND framework guidance accessible | Strong pathway for trials and compassionate use; still lacks phage-specific pharmacopeial monograph comparable to Ph. Eur. 5.31. |
| Belgium | Magistral preparations with API monograph + centralized QC | 2018 framework (phage APIs as inputs into magistral preparations) remains a global reference model; a large 100-case dataset was published in 2024 | Demonstrates the feasibility of regulated personalization and QC auditing; highlights scalability/availability constraints (many requests not treated). |
| Australia | Special Access Scheme (SAS) for unapproved therapeutics; evolving GMP proportionality | SAS guidance updated Oct 2024; consultation on GMP exemptions for certain phage manufacture in late 2025 | Pathway supports clinical access; publishability depends on consistent QC and prospective registries/trials rather than ad hoc use. |
| France (historical + evolving) | Temporary authorization approaches described in the literature; evolving national initiatives | Literature notes ATUn-type recommendations historically; 2026 conference/industry signals suggest GMP platform initiatives. | Evidence for structured national manufacturing is emerging, but peer-reviewed regulatory documentation is less centralized than UK/European Union channels. |
Ph. Eur.: European Pharmacopoeia; EMA: European Medicines Agency; IND: Investigational New Drug; GMP: Good Manufacturing Practice; MHRA: Medicines and Healthcare products Regulatory Agency; QC: quality control.
The author acknowledges the use of Paperpal (https://paperpal.com/), an AI-powered academic tool, for language editing and academic paraphrasing to enhance the clarity and readability of the manuscript. The use of AI tools was strictly limited to linguistic refinement; all intellectual content, scientific interpretations, data analysis, and conclusions are entirely the authors’ own.
POO: Conceptualization, Investigation, Writing—original draft. TSF: Conceptualization, Investigation, Writing—original draft. OJO: Writing—original draft, Writing—review & editing. All authors have read and approved the final manuscript.
The authors declare that they have no conflicts of interest.
Approval from the ethics committee was not required.
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Data sharing does not apply to this article, as no datasets were generated or analyzed during the current study.
The authors have not received any funding for this study.
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