New category of biological medicinal products relevant for microbiome-based drugs NovoBiome supports the introduction of a new category of SoHO-derived medicinal products in the proposed Directive on the Union code relating to medicinal products for human use.
NOV
NovoBiome
Company · France
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2
positions filed
in the 583 files tracked
2
legislative files
of 583 tracked
0
with a full position paper
attached to a submission
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Their record over time
NovoBiome filed 2 positions between 8 Sept 2022 and 7 Nov 2023, across 2 of the 583 legislative files tracked here.
2022 · 1 filed2023 · 1 filed
What they argued
Our company develops microbiota-derived Live Biotherapeutic Products We have a couple of concerns: 1. Regarding the updating of Pharmaceutical legislations, will SoHO or the legislation prevail? Shall we need to fulfill both drug and SoHO preparations requirements? 2. Regarding single strains, will they be considered as SoHO, which is highly questionable Best,
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Turns up on the same files
Organizations that also filed on at least two of the same consultations. A shared interest in the same dossiers — not evidence of coordination, and we do not suggest any.
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