European Regulatory Developments: Uncovering the New SoHo Regulation & Outlining the Revision of the General Pharmaceutical Legislation
Time: 11:30 am
day: Day 2 Track A AM
Details:
- Recognizing microbiome samples as a source of innovative treatments and recent regulatory developments are helping to clarify the regulatory pathway to market authorization
- Human microbiome samples will be included in the scope of the new European SoHO regulation, which is expected to come into force in 2026
- Outlining that the published first draft of the upcoming new EU general pharmaceutical legislation will specify the interplay between the SoHO and Pharma regulations, including the definition of “SoHO-derived medicinal products other than ATMPs
