PHARMABIOTIC RESEARCH INSTITUTE
Budget
€25 — €0
EP Access
0
accredited persons
Staff
2
0.35 FTE
EU Grants
€32,348
Mission & Goals
The PRI is a non for profit organization supporting its academic and industry members in their effort to develop microbiome-based products. The PRI is the only European Excelence Center for Microbiome Regulatory Science and supports its members in their interaction with the competent authorities (European and national) in order to better understand the expectations of the competent authorities in regards to microbiome-based products in absence of a dedicated European regulatory framework. The PRI is also the first network for the European microbiome industry, federating fundamental actors such as stakeholders involved in the development, investment, production and commercialization of microbiome-based products within the EU.
EU Legislative Interests
- EU Life science strategy - EU Biotech Act - SoHO regulation, Stakeholder at the SCB level, partner in the HARMONIZE EU4 health project (GRANT number 101196606) - Proposal for a Regulation of the European Parliament and of the Council on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC: Participation to 2 stakeholders workshop and in the public consultation. - Revision of the general EU Pharmaceutical Legislation: Participation in 1 stakeholder workshop and participation in the public consultation on the following proposals i) Proposal for a Directive of the European Parliament and of the Council on the Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC ii) Proposal for Regulation of the European Parliament and of the Council laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency, amending Regulation (EC) No 1394/2007 and Regulation (EU) No 536/2014 and repealing Regulation (EC) No 726/2004, Regulation (EC) No 141/2000 and Regulation (EC) No 1901/2006
Communication Activities
Information of PRI members and microbiome field about the new SoHO regulation via: - website and Linkedin publications - scientific publication (DOI: 10.1038/s41522-025-00683-0) - oral comunication in different public events Information of PRI members about the EU biotech act and coordination of an answer to call for evidence. Information of PRI members and microbiome field about EU Life science strategy (email campaign and Linkedin post) Information about the release of the proposal and opening of the public consultation on i) Proposal for a Regulation of the European Parliament and of the Council on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC Were disseminated to the PRI members and PRI network: https://www.pharmabiotic.org/european-commission-makes-public-proposed-revision-to-btc-regulation/ https://www.linkedin.com/posts/pharmabiotic-research-institute-pri_the-pri-members-area-is-online-the-activity-7069616765948817408-pWE3?utm_source=share&utm_medium=member_desktop
Interests Represented
Promotes their own interests or the collective interests of their members
Member Of
No membership in any other organization
Organisation Members
https://www.pharmabiotic.org/our-members/
Additional Information
The European Union Horizon 2020 - grant Agreement 964590 (IHMS-CSA project) is for a three years project which has started on May 1st, 2021 and has granted the PRI 150 688,75€ for three years. The PRI has recieved a first payment from the project coordinator (INRAE, France) of 48000 euros in july 2021 (PRI fiscal year 2020-2021) . Then the PRI has also received another payment of 47868,75€ on June 2022 from the project coordinator (INRAE, France) <=> Fiscal year 2021-2022 for the PRI. The PRI has received an additional paiement of 32348€ in Jan 2024 (fiscal year 2023-2024, current fiscal year).
Commissioner Meetings
No recorded meetings with EU commissioners.