The Animal Model Qualification Program (AMQP) is a Drug Development Tool Qualification Program specifically established to address the need for publicly available, product-independent animal models intended to support the efficacy testing of multiple investigational drugs or biological products under the regulations commonly known as the Animal Rule.  Submitting a model for qualification is voluntary, and approval of a drug or biological product under the Animal Rule does not require the use of a qualified model.   

The AMQP provides a framework for early engagement and scientific collaboration with FDA to facilitate animal model development.  Qualification of an animal model through the AMQP indicates that:

1. FDA has concluded that the animal model (i.e., the specific combination of an animal species, challenge agent, route of exposure) can reliably produce a disease process or pathological condition that in multiple important aspects corresponds to key elements the human disease or condition of interest.
2. FDA has accepted the animal model’s context of use, which is a description of the appropriate use and application of the qualified animal model in drug development and regulatory review, as well as the details that provide measures of quality control and quality assurance when the models is replicated.

Developing animal models for use in efficacy testing under the Animal Rule is resource-intensive in terms of animals, money, and time.  Qualifying an animal model reduces redundancy in animal model development efforts and conserves resources.  Once an animal model is qualified, FDA will make the qualification determinations publicly available, thereby allowing sponsors of investigational product to use qualified animal models, when appropriate, in their product development. 

The selection of appropriate animal models is critical to establishing whether an investigational drug is reasonably likely to produce clinical benefit in humans.  The sponsor of an investigational drug should provide scientific justification that each animal model used exhibits key characteristics of the human disease or condition of interest and that each animal model used is appropriate for use with the investigational drug.  

The use of qualified animal models for testing the efficacy of investigational drugs and biological products being developed under the Animal Rule will expedite product development and FDA’s review of the regulatory applications.  When a sponsor uses a qualified animal model within the bounds of its context of use in a regulatory application, FDA does not have to reevaluate that the qualified animal model adequately models key elements of the human disease or condition of interest.