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: €6M+ 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.
EFPIA · filed 27 Apr 2021 · source
EFPIA supports an agile regulatory framework and a strong incentives’ system that embrace and encourage advances in science, technology & medicines. This evaluation is an opportunity to implement learnings from COVID-19 and ensure a competitive, world-class regulatory system in Europe supporting a globally competitive research-based industry at a critical time.
EFPIA · filed 3 Oct 2023 · source
EFPIA supports the objectives of enhancing the availability and accessibility of medicines, while fostering a competitive innovation environment in Europe. We welcome the proposal to future-proof the EU regulatory framework, maximising the use of expedited pathways, optimising regulatory decision-making processes, and reducing unnecessary administrative burdens.
EFPIA · filed 9 Oct 2023 · source
EFPIA supports the objectives of enhancing the availability and accessibility of medicines, while fostering a competitive innovation environment in Europe. We welcome the proposal to future-proof the EU regulatory framework, maximising the use of expedited pathways, optimising regulatory decision-making processes, and reducing unnecessary administrative burdens.
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.
EFPIA · filed 11 Dec 2020 · source
Revision of the Blood, Tissues & Cells (BTC) Legislation offers an important opportunity to ensure regulatory standards safeguarding patient safety and public health keep pace with technical and scientific advances, legal certainty and risk-based flexibility to facilitate innovation, and sustainability of supplies across EU for both therapeutic need and producing products derived from BTC.
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,
EFPIA · filed 8 Sept 2022 · source
The proposed Substances of Human Origin(SoHO) Regulation intends to harmonize measures for Member States and organizations involved in activities related to SoHOs for human application, facilitating cross-border exchange and continuity of supply in the EU. EFPIA supports these aims but is concerned about areas of the SoHO Regulation that appear incoherent with medicinal product regulation.
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