EU Microbiome
Regulatory Science Center
Applying regulatory science for new therapies and diagnostics
The PRI is the European Microbiome Regulatory Science Expertise Center, created in 2010 to support the development and registration of therapeutic and diagnostic products emerging from microbiome science.
We work to educate and contribute to the conditions of success for future medicinal innovations emerging from microbiome science, and our ultimate objective is to see these therapeutic innovations achieve EU marketing authorization, thereby giving European patients access to registered microbiome-based medicinal products or validated diagnostics.
Microbiome-based medicinal products
Complex technologies with ecosystemic effects
The future of human and veterinary medicine has been forever changed by the fundamental disruption of microbiome science – we are only now understanding ‘health’ as an ultimate result of a complex interaction between host and one’s microbiome.
The EU Regulatory Framework & Landscape
As for any other medicinal products, microbiome-based medicinal products must comply with the pharmaceutical standards for quality, safety and efficacy and will require a medicinal product marketing authorization to reach market.
The system for regulating medicines in Europe is unique. It is based on a closely coordinated regulatory network of national competent authorities in the Member States of the European Economic Area (EEA), working together with the European Medicines Agency (EMA) and the European Commission.
Overall, most microbiome-based medicinal products are moving through the development process based on interactions between developers and regulators at the national level in a select few of EU member states.
Microbiome Regulatory Science News & Events
PRI welcomes Camille Bello as Communication and Membership Manager
We are pleased to announce that Camille Bello has joined the Pharmabiotic Research Institute (PRI) as Membership and Communication Manager. Camille brings over a decade of experience in journalism, strategic communication, and stakeholder engagement, along with a...
PRI Board of Director members elects Eleni Tsompanidou as New President
The Pharmabiotic Research Institute (PRI) is pleased to announce the election of Eleni Tsompanidou (Winclove Probiotics) as the new President of the Board of Directors and Executive Committee. Eleni was elected by the PRI Board Members during the latest meeting held...
Microbiome-based Biomarkers – a multidisciplinary Delphi consensus (The Lancet Microbe)
The Pharmabiotic Research Institute, as a partner of the Human Microbiome Action Consortium, is pleased to announce the publication of the paper, "State of the art and the future of microbiome-based biomarkers: a multidisciplinary Delphi consensus", J. Rodriguez et...
