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Viruses 2019, 11(4), 352;

Phage Therapy Regulation: From Night to Dawn

Culture In Vivo ASBL, rue du Progrès, 4, boîte 7, 1400 Nivelles, Belgium
Received: 28 February 2019 / Revised: 23 March 2019 / Accepted: 7 April 2019 / Published: 17 April 2019
(This article belongs to the Special Issue Hurdles for Phage Therapy (PT) to Become a Reality)
PDF [219 KB, uploaded 17 April 2019]


After decades of disregard in the Western world, phage therapy is witnessing a return of interest. However, the pharmaceutical legislation that has since been implemented is basically designed for regulating industrially-made pharmaceuticals, devoid of any patient customization and intended for large-scale distribution. Accordingly, the resulting regulatory framework is hardly reconcilable with the concept of sustainable phage therapy, involving tailor-made medicinal products in the global perspective of both evolutionary and personalized medicine. The repeated appeal for a dedicated regulatory framework has not been heard by the European legislature, which, in this matter, features a strong resistance to change despite the precedent of the unhindered implementation of advanced therapy medicinal product (ATMPs) regulation. It is acknowledged that in many aspects, phage therapy medicinal products are quite unconventional pharmaceuticals and likely this lack of conformity to the canonical model hampered the development of a suitable regulatory pathway. However, the regulatory approaches of countries where phage therapy traditions and practice have never been abandoned are now being revisited by some Western countries, opening new avenues for phage therapy regulation. As a next step, supranational and international organizations are urged to take over the initiatives originally launched by national regulatory authorities. View Full-Text
Keywords: phage therapy; PTMP; ATMP; regulatory framework; pharmaceutical paradigm shift; clinical trial; magistral formula; personalized medicine phage therapy; PTMP; ATMP; regulatory framework; pharmaceutical paradigm shift; clinical trial; magistral formula; personalized medicine
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited (CC BY 4.0).

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Fauconnier, A. Phage Therapy Regulation: From Night to Dawn. Viruses 2019, 11, 352.

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