December 20, 2021
Today, the FDA’s Center for Veterinary Medicine is announcing an eSubmitter update that will enable animal drug manufacturers to provide more complete facility information, particularly about the establishments that are actively used in their manufacturing processes. The enhancement will enable animal drug manufacturers to provide supply chain data that will strengthen FDA’s ability to monitor the animal drug supply chain and efficiently address any animal drug supply chain issues that may arise.
This enhancement is part of the Animal Drug and Manufacturing System (ADMS), a project funded by The Coronavirus Aid, Relief, and Economic Security Act (CARES Act) in response to the COVID-19 public health emergency. Collecting facility information will enable CVM to rapidly access information on animal drug products, active pharmaceutical ingredients, and the status of manufacturing sites, so that the agency can identify and address critical facilities and animal drugs impacted by emerging diseases or natural disasters and help to identify solutions to potential animal drug shortages.
This step brings CVM in line with the FDA’s other medical product centers that already require human drug and biologic manufacturers to provide facility information and operational status. CVM will phase in the new eSubmitter templates over the next six months; however, animal drug manufacturers may begin using the ADMS book (found within eSubmitter under the “Tools” menu) to provide facility information on a voluntary basis immediately. This information will be required when animal drug sponsors make new submissions to the eSubmitter program once updated versions of each template are released. Animal drug sponsors can view the CVM eSubmitter Programs webpage for more information, including the release schedule for the updated templates. The page also includes a new webinar outlining the eSubmitter update, including how sponsors can provide facility information and operational status through the program.
Issued by FDA Center for Veterinary Medicine.
For questions, Contact CVM.