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 · Germany
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.
Bundesverband der Pharmazeutischen Industrie e.V. · filed 27 Apr 2021 · source
The BPI e.V. (BPI) representing more than 270 members, comprises the whole spectrum of the pharmaceutical industry, ranging from multinational corporations to SMEs, Mid-Caps as well as Startups. These companies ensure a timely and safe supply of medicinal products for all patients across the EU and globally.
Bundesverband der Pharmazeutischen Industrie e.V. · filed 1 Nov 2023 · source
BPI welcomes the revision of the EU´s general pharmaceutical legislation and the Pharma Package (EU Pharmaceutical Legislative Revision) published by the European Commission on 26 April 2023. After more than 20 years, a revision of the existing provisions was necessary to ensure a legal framework that is adapted to the state of technology and research, while reducing bureaucracy to ensure that medicinal products can…
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.
Bundesverband der Pharmazeutischen Industrie e.V. · filed 31 Aug 2022 · source
BPI welcomes the proposal for a Regulation on Substances of Human Origin (SoHO) presented by the European Commission on 14 July 2022 to replace the current EU legislation on blood, tissues and cells (BTC). The European Union needs a predictable, future-proof and resilient regulatory framework for SoHO.
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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