The Regulatory Landscape for Microbiome Medicinal Products
The past few years have been full of change in the microbiome regulatory space. Just last month we saw the authorisation of the use of the term “probiotic” by French authorities (read more here), and in 2022 there were three microbiome drugs approved in their respective markets. As the microbiome drug category matures, regulatory harmonisation will help to improve patient access to these innovative treatments, while ensuring these products’ safety and efficacy in humans.
In Europe, one major regulatory change that is approaching is the proposal for a regulation on Substances of Human Origin by the European Commission. Repealing the existing “Blood Directive (2002/98/EC)” and the “Tissues and cells Directive (2004/23/EC)”, the new proposed regulation will regulate all substances of human origin (SoHO). The definition of SoHO includes “any substance collected from the human body in whatever manner, whether it contains cells or not and whether those cells are living or not”. The goal of this change is to improve harmonization across EU member states, and “improve patient access to therapies they need”. Given the human origin of many active substances used in microbiome-based medicinal products, this regulation may very well impact microbiome product development in Europe in the coming years.
To better understand the regulatory horizon in Europe join us at the upcoming 2023 Pharmabiotics Conference where the SoHO revision, and other regulatory queries will be explored.
Here are some highlights of the event discussing microbiome-based medicinal product regulatory science:
Stefaan van der Spiegel, Team Leader - Substances of Human Origin, European Commission
Heading up the team responsible for drafting the SoHO revision, Stefaan will be discussing the implications of the new proposal. Gain insight into how this major shift may affect your drug development activities by hearing directly from the European Commission.
Mirela Busic, Head of SoHO Standards Section, EDQM
Responsible for developing quality standards published in the European Pharmacopoeia, the EDQM represent the leading authority on drug standards in Europe. Mirela will be discussing EDQM standards for Substances of Human Origin.
Ken Blount, VP Microbiome Research, Ferring Pharmaceuticals
As Chief Scientific Officer for Rebiotix, a Ferring Company, Ken Blount worked towards the first US-FDA approved donor-derived microbiome therapeutic, Rebyota. Hear Ken discuss his experience navigating the US regulatory field both from his perspective as CSO at Rebiotix, as well as former chair of the Microbiome Therapeutic Innovation Group (MTIG).
Chiara Bertarello, Business Development & Contracts Management, Proge Farm
Proge Farm made headlines in 2022, as the first European-based company to receive a market authorization for a microbiome-based medicinal product. Working to comply with legislation and assist with overcoming regulatory hurdles, Chiara will discuss Proge Farm’s innovative journey to market approval.
Staffan Stromberg, CEO, Infant Bacterial Therapeutics
Regulatory compliance lies at the heart of Infant Bacterial Therapeutics’ mission to bring pharmaceutical grade probiotics to preterm infants. Learn how Staffan leads IBT to follow rigorous pharmaceutical control for regulatory success.
Hear all of these presentations in person by registering for your ticket HERE
