The PRI welcomes the proposal for a pharma Regulation which will forge further EU harmonization in terms of the quality, safety, and efficacy assessment of "SoHO-derived medicinal products other than ATMPs (hereinafter abbreviated SoHO-DMP). Integration of provisions addressing Orphan and Pediatric medicinal products within the proposal for Regulation is also welcome as it serves for better centralization.
PRI
Pharmabiotic Research Institute
NGO · France · EU Transparency Register 897994636209-21
6
positions filed
in the 665 files tracked
3
legislative files
of 665 tracked
5
with a full position paper
attached to a submission
Counts here are a floor, never a total: they cover the 665 consultation files tracked so far (57,774 submissions, mostly 2021–26), so an organization's real filing history is larger, not smaller.
Who they are
Among the 1106 non-governmental organisations on this site, they rank #378 by legislative files engaged, a count of participation, not a measure of influence.
0.3
declared lobbying FTE
self-declared
€25K+
declared costs / yr (floor)
0
EP accreditations
as declared to the register
2019
in the register since
Declares membership of
- No membership in any other organization
Self-declared to the EU Transparency Register (snapshot 14 Oct 2026).
- Register category
- Non-governmental organisations
- Registered as
- PHARMABIOTIC RESEARCH INSTITUTE (PRI)
- Head office
- Brussels, Belgium
Self-declared to the EU Transparency Register (snapshot 14 Oct 2026); cost bands are floors, not audited totals. Reused under Commission Decision 2011/833/EU.
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Their record over time
Pharmabiotic Research Institute filed 6 positions between 14 Dec 2020 and 5 Aug 2026, across 3 of the 665 legislative files tracked here, attaching a full position paper 5 times.
2020 · 1 filed2022 · 1 filed2023 · 2 filed2025 · 1 filed2026 · 1 filed
What they argued
The PRI welcomes the proposal for a new Directive as it is a step towards recognizing microbiome-based medicinal products by defining SoHO-derived medicinal product other than ATMPs (hereinafter abbreviated SoHO-DMP) (which will include microbiome-based medicinal products produced from human microbiomes). However, specific requirements applicable to these products remain unknown.
The Pharmabiotic Research Institute (PRI) welcomes the European Commission's proposal for a European Biotech Act. The proposal represents a timely and important opportunity to strengthen Europe's biotechnology ecosystem by improving competitiveness, fostering innovation, facilitating investment and enhancing regulatory efficiency while maintaining the Union's high standards of public health, food safety…
The Pharmabiotic Research Institute (PRI) is a non-profit European organisation dedicated to advancing regulatory science for microbiome-based innovations. PRI welcomes the initiative to establish a European Biotech Act to support innovation, scale-up, and competitiveness in the EU biotech sector. 1.
The PRI welcomes the proposal for a Regulation on standards of quality and safety for Substances of Human Origin (SoHO) intended for human application which will increase EU harmonization on protection of the rights and safety of SoHO donors and recipients.
Border between substances of human origin' legal framework and substances of human origin-derived medicines' legal framework is not clear and this create confusion and inequality in the requirements expected from hospitals compared to other sponsors such as pharmaceutical industries. This is the major challenge to be addressed for the coming years.
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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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Quotes are verbatim from submissions published by the European Commission, trimmed to their opening passage and never summarized by a model. Organizations only, never individuals. Reused under Commission Decision 2011/833/EU; the European Commission is not liable for this reuse.