Her presentation is titled “European Regulatory Developments: Uncovering the New SoHo Regulation & Outlining the Revision of the General Pharmaceutical Legislation.”
Revisions to the EU regulatory landscape will directly impact microbiome innovators
In the context of the ongoing revision to the regulatory framework dealing with blood, tissues and cells, the proposal for a new Substance of Human Origin (SoHO) regulation was initially published in July 2022 by the European Commission. Based on the proposal currently available, Human microbiome samples will be included in the scope of the new European SoHO Regulation.
“One detail of this regulatory update that may be easily missed – this regulation’s scope applies to any human microbiome samples intended for human application – this means any regulatory status, not just pharma applications…But what is sure is that microbiome innovators will have to consider these regulatory updates along with their development planning – as the new regulation is expected to come into force as early as 2026.” (Read more about this important update here)
EU Pharmaceutical legislation is also under revision (first draft published in April 2023)
In April 2023 the European Commission published the first draft of the long-awaited revision to the EU general pharmaceutical legislation (read more here). These texts will shape the European regulatory landscape for decades to come. The text will specify the interplay between the SoHO and Pharma frameworks, including the proposal for a definition of “SoHO-derived medicinal products other than ATMPs”.
Join Céline, Joseph and a large delegation of PRI Members in Barcelona at the annual event.
- Matthew Robinson of Microbiotica
- Katja Conrath & Selin Bolca of MRM Health
- Karine Roget of Nexbiome Therapeutics
- Johan van Hylckama Vlieg of Freya Biosciences
- Ana Montalban-Arques of Recolony
- Elran Haber of Biomica
- Denise Kelly of Seventure Partners
- Gabriel Leventhal & Tomas de Wouters of Pharmabiome
- Massimo Marzorati of ProDigest
- Pedro de Sampaio & Annelise Soulier of Neobe Therapeutics
…as well as representatives from Biose Industrie, ReciBioPharm, and SACCO Systems as event supporters.