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
Exploring the proposed regulation on SoHO (Céline Druart, London Feb. 2023)
This week PRI Microbiome Project Manager Céline Druart (PhD) will speak at Hanson Wade's Microbiome Movement Drug Development Europe event. Her presentation is titled, "Exploring the EU Proposal for a new SoHO Regulation and the Impact on Microbiome-based Medicinal...
EDQM Publishes Guide on Quality of Tissues and Cells – 5th Edition
The EDQM (European Directorate for the Quality of Medicines & Healthcare) has released the 5th version of the Guide to the quality and safety of tissues and cells for human application on 15 December 2022. This updated version results from an extensive revision...
PRI Board elects new President Sandrine Claus, Executive Committee
The PRI is pleased to announce Dr. Sandrine Claus has been elected Association President (effective 9 January 2023). As President, Sandrine will lead the Executive Committee and Board of Directors within the Association. Since the last update to the PRI Bylaws (Dec...
