In January 2025, FDA released the final guidance CVM GFI#187B on the approval process for animals containing heritable intentional genomic alterations. Check out the Final guidance document here #187B Heritable Intentional Genomic Alterations in Animals: The Approval Process . This compliments the final CVM#187A that describes FDA’s risk-based approach to determining their requirements and recommendations to
Author Archives: animals
Colombia completes review of PRRS resistant pig. – In October 2023, Columbia became the first country to grant approval to Genus plc for their gene-edited PRRS resistant pig. Read all about that accomplishment here. Colombia is First Country to Issue Positive Regulatory Determination for PIC’s PRRS-Resistant Pig – PIC North America
Stay up to date on the status of animals developed for agricultural applications through gene editing (New Breeding Techniques) by checking out the ISAAA Animal database that is managed in collaboration with the University of California – Davis, USA. You can find the database by following this link – Gene-Edited Animals for Agricultural Applications Database
In January 2025, the Australian New Zealand Food Standards Code was amended by FSANZ in accordance with Amendment No. 234. Included in that amendment was Schedule 26 Food produced using gene technology. Read Schedule 26 here – Federal Register of Legislation – Australia New Zealand Food Standards Code – Schedule 26 – Food produced using