Expert Proposes Techniques to Address Regulatory Concerns in Gene Editing

Martin Lema, Adjunct Professor at the National University of Quilmes, released an article containing a detailed review of evidence on off-target effects and unintended DNA insertions in gene editing. The document, published in the Journal of Regulatory Science, is a useful resource in proposing concrete regulatory criteria to address the issues.

According to Lema, there is an increasing number of regulatory systems worldwide that consider applications for the authorization of activities involving the use of gene editing for agri-food use. Several countries have progressed in creating regulatory criteria and collecting practical experiences in the field, but there is still a general need for regulatory cooperation on capacity building and forming with harmonized criteria. Thus, the article included a simplified introduction of genome editing from a regulatory perspective.

A pragmatic and proportionate approach for addressing off-target effects and unintended DNA insertions was proposed. If the proposed techniques would be adopted, it is expected that there will be a harmonized approach that could also help developers enhance the safety of their experimental design and protocols, which can lead to cheaper costs and lesser complications in the regulatory assessment.

Download the article from the Journal of Regulatory Science.