Advice Update on prerequisites for generic environmental risk assessment of clinical studies and marketing applications involving ex vivo retro- and lentiviral transduced cells

In 2019 and 2020, COGEM conducted generic environmental risk assessments for clinical studies involving cells that have been modified outside the body (ex vivo) using retroviral and lentiviral vectors. These assessments established conditions that clinical studies must meet to ensure that environmental risks are negligible. These assessments also contributed to the drafting of permits under fixed conditions (‘vergunningen onder vaste voorwaarden’, VoVs) in the Netherlands. This allows such studies to be processed more quickly and easily.

Following the initial assessments, COGEM issued additional recommendations. Some prerequisites were tightened or amended in line with new insights.

The current advice updates the previous generic environmental risk assessments. It summarises and explains the current prerequisites for clinical studies involving the use of ex vivo retro- and lentiviral transduced cells. COGEM considers the risks to humans and the environment in such clinical studies to be negligible if these prerequisites are met. COGEM recommends incorporating these updated prerequisites into the VoVs.