Navigating regulatory approval pathways for EngBio applications in the environment sector (NAVIREG)

Principal investigator: Paul Jeffrey (Cranfield University)

Paul Jeffrey

Project Summary

Parliament has recently acknowledged (in the 2025 ‘Don’t Fail to Scale’ report) that regulatory pathways for new Engineering Biology (EngBio) products and technologies 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 of EngBio where multiple regulators might be involved and specialised biocontainment techniques required.

Challenges Facing EngBio Innovators

Discussions with EngBio start-ups and spin-outs in preparation for this proposal have revealed some concerns:

  • Regulatory Approval Uncertainty: some innovators struggle to understand regulatory approval pathways, are unsure about the thresholds applied and quality of evidence required to demonstrate safe use.
  • Regulatory Burden: innovators are nervous about the potential impact of perceived high regulatory burden / risk on investors

Project Objectives

This project’s aim is to better understand the regulatory approval challenges facing environmental EngBio businesses. To achieve this we will work with pre-commercial EngBio solution providers and regulators to undertake two distinctive activities;

  1. Two regulatory approval dry runs using EngBio applications targeted at the water sector and focusing on the evidence base required to demonstrate effective biosafety / biocontainment.
  2. A regulatory pathway mapping activity from early-stage discovery to market authorization for a minimum of 10 specific EngBio applications.

Delivering Practical Guidance for the Sector

Sector facing outputs include guidance on regulatory approval pathways and recommendations on modifications to regulatory processes. The project will illustrate what a credible regulatory approval submission comprises of, and clarify forms, levels, and quality of risk management evidence; thereby lowering the costs of regulatory approval and market access.

Through these initiatives, the project will contribute to creating a more efficient, predictable regulatory landscape, enabling faster deployment of sustainable EngBio solutions to address environmental challenges.