Covered in the document are requirements and recommendations for those producing pharmaceutical products using GE animals.
At present very few drugs produced in GE animals have reached commercialisation but given the system’s potential this is expected to change in coming years.
Randall Lutter, FDA deputy commissioner for policy, said: "Genetically engineered animals hold great promise for improving human medicine, agriculture, the environment, and the production of new materials and the FDA has long been involved in their scientific evaluation.
"Our guidance provides a framework for both GE animals and products made from them to reach the market."
Drugs produced within GE animals are, like therapeutics produced by more traditional means, subject to safety and effectiveness tests by the Center for Drug Evaluation and Research (CDER).
However, guidelines for the creation and maintenance of the manufacturing equipment, in this case a GE animal, pose some unique regulatory challenges that the FDA has sought to tackle in its draft guidance.
Within the section entitled “Manufacturing Methods, Facilities, and Controls” the FDA details the guidelines related to production, processing, and packing of GE animals.
This includes the information that must be submitted if a company is to be granted a successful new animal drug application (NADA), which grants the right to produce and keep GE animals.
To be successful an animal’s ploidy and zygosity, name and function of the rDNA construct and the intended use of the resulting GE animal must be supplied by the applicant.
Measures to ensure that the GE animal is not detrimental to the wider environment are also contained in the FDA’s guidance.
These environmental considerations are intended to minimise the likelihood of the animal or its products being inadvertently released from the production site. Included in this are issues related to the shipping, labelling and storage of GE animals.
Correct disposal of the animals should also be undertaken, to prevent edible products from GE animals entering the food or feed supply. The FDA recommends incineration, burial, or composting of the animal and that appropriate records of the procedure are kept.
The full draft guidance is available here. Comments can be submitted here until November 18.
Additional documentation is to be published in the future, detailing how good manufacturing practices (GMPs) apply to GE animals.