Side by side
Consultation participation and their own register declarations, side by side. Counts, not judgments — participation is not influence.
Counts here are a floor, never a total: they cover the 583 consultation files tracked so far (42,224 submissions, mostly 2025–26), so an organization's real filing history is larger, not smaller.
Company · France
Industry association · Belgium
Declared costs: €100K+ a year · in the register since 2009
Medicinal products for human use · Standards of quality and safety for substances of human origin intended for human application
Register facts self-declared (snapshot 2 Sept 2026); cost bands are floors. Shared files are shared attention, not evidence of coordination.
Their opening passages on the files they share, verbatim and in filing order. We do not summarize, compare, or characterize positions — read them at source.
EuropaBio · filed 27 Apr 2021 · source
The evaluation and revision of the general pharmaceutical legislation is the opportunity to create a future-proof, patient-oriented and leading life sciences and biotechnology sector in the EU. New biotechnology-derived vaccines and treatments have helped to tackle numerous life-threatening illnesses. Targeted cell and gene therapies and new mRNA platforms are paving the way for future treatments.
EuropaBio · filed 9 Oct 2023 · source
In the last 20 years, biotech transformed the pharmaceutical industry and enabled the development of breakthrough therapies that are live-saving or significantly improving quality of life of patients and their families. The development of biotech in Europe also continues to positively contribute to the regions economic well-being.
NovoBiome · filed 7 Nov 2023 · source
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.
EuropaBio · filed 7 Sept 2022 · source
EuropaBio welcomes the adoption of the proposal for a Regulation on SoHO revising the EU’s Blood, Tissues, and Cells (BTC) legislation. The EU needs a predictable, future-proof, and robust SoHO framework to ensure the uptake of transformative advanced therapies which hold great potential for both the health and wellbeing of patients and the sustainability of healthcare systems.
NovoBiome · filed 8 Sept 2022 · source
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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