What are the current guidelines for environmental risk assessments of ATMPs, particularly those involving GMOs?

FAST themes ATMPs
1

We are developing an ATMP involving GMOs and need to conduct an ERA. What are the specific guidelines we should follow?

2

Hi Rosa,

You should follow the guidelines and requirements found in these key documents:

Guideline on the Environmental Risk Assessment of Medicinal Products for Human Use
This guide helps you figure out the step-by-step process for the ERA

For GMOs, a specific ERA is required: Guideline on Environmental Risk Assessment for Medicines with GMOs
This guide focuses specifically on products that contain or are made from GMOs