- Dates1 February 2026 to 30 January 2027
- SponsorBBSRC
- Funded£170k
- PartnersUniversity of Southampton. Five UK regulators with responsibility for approving Synthetic Biology applications.
Parliament has recently acknowledged that regulatory pathways for new Engineering Biology (EngBio) products remain unclear and that in such a fast-moving sector, early coordination between industry and regulators is crucial. This challenge is particularly evident when it comes to environmental applications where multiple regulators might be involved and specialised biocontainment techniques required.
This project’s aim is to better understand the regulatory approval challenges facing environmental EngBio businesses. We are working with pre-commercial EngBio solution providers and regulators to undertake; (i) regulatory approval dry runs using EngBio applications targeted at the water sector and focusing on the evidence base required to demonstrate effective biosafety / biocontainment, and (ii) regulatory pathway mapping from early-stage discovery to market authorization for 10 EngBio applications.