Phage Therapy Regulation: From Night to Dawn
Phage Therapy Regulation: From Night to Dawn
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DOI：
10.3390/v11040352
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发表时间：
2019-04-01
期刊：
影响因子：
4.7
通讯作者：
Fauconnier, Alan
中科院分区：
文献类型：
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作者：
Fauconnier, Alan
在西方世界被忽视了几十年之后，噬菌体疗法正在重新引起人们的兴趣。然而，此后实施的药物立法基本上是为监管工业制造的药物而设计的，没有任何病人定制，旨在大规模分销。因此，由此产生的监管框架很难与可持续噬菌体治疗的概念相协调，涉及从进化和个性化医学的全球角度定制的医药产品。欧洲立法机构没有听到对专门监管框架的反复呼吁，尽管有不受阻碍地实施先进治疗药品（ATMP）监管的先例，但在这一问题上，欧洲立法机构强烈抵制变革。公认的是，在许多方面，噬菌体治疗药物产品是相当非常规的药物，并且可能这种与规范模型的不一致性阻碍了合适的调控途径的开发。然而，噬菌体治疗传统和实践从未被放弃的国家的监管方法现在正被一些西方国家重新审视，为噬菌体治疗监管开辟了新的途径。作为下一步，敦促超国家和国际组织接管最初由国家监管当局发起的举措。
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.