How are gene drive modified mosquitoes regulated?

Government regulation of gene drive-modified mosquitoes likely will involve more than one regulatory authority, and more than one type of permit for importation and research. In countries that are Parties to the Cartagena Protocol, genetically modified organisms must be reviewed through a biosafety mechanism established under the national biosafety law. It is expected that Ministries of Health and Ministries of Environment, and possibly others, will be involved. In the US, which is not a signatory to the Cartagena Protocol, genetically modified mosquitoes aimed at reducing population size (population suppression approaches) currently are regulated by the Environmental Protection Agency, while genetically modified mosquitoes that aim to reduce vectorial capacity (population modification) are regulated by the Food and Drug Administration.

For more information:

https://www.who.int/publications/i/item/9789240025233 

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10102045/
https://bch.cbd.int/protocol/background/
https://www.cbd.int/doc/legal/cartagena-protocol-en.pdf
https://www.fda.gov/media/102158/download