Advice updating the prerequisites for the ERA of clinical studies with GM cells available in English

COGEM published an English translation of her recent advice which provides an update of the prerequisites for clinical studies with cells that have been genetically modified outside the body (ex vivo) using retroviral and lentiviral vectors.

Previously, in 2019 and 2020, COGEM established conditions that a clinical study must meet in order to ensure in advance that the environmental risks are negligible. Later, additional advice was issued in which some conditions were tightened or changed based on advancing insights.

The new advice provides an update of the earlier generic environmental risk assessments, and is now also available in English.

Read the advisory report here:  Advice Update on prerequisites for generic environmental risk assessment of clinical studies and marketing applications involving ex vivo retro- and lentiviral transduced cells