Do animal models have to be qualified?
No; submitting an animal model for qualification is voluntary.
Is the use of a qualified animal model required for product approval or licensure under the Animal Rule?
The use of a qualified model is not required for product approval or licensure under the Animal Rule.
Why should an animal model developer seek qualification for an animal model?
The animal model qualification process provides a defined framework for the submission, review, and regulatory acceptance of an animal model as a drug development tool (DDT) for use in multiple drug development programs. This framework provides for interactions between FDA and the submitter throughout the model development process, thereby allowing for ongoing consultation. A qualified animal model is developed independently of any specific drug (i.e., product-independent); the use of a qualified model in multiple drug development programs targeting a particular disease or condition eliminates the need to develop specific models for each investigational new drug. Overall, qualification of an animal model results in the reduction of time, animals, and resources committed by any one animal model development program.
What is the meaning of the term “product-independent models?”
A product-independent model means that the animal model is not specific to a particular investigational drug. Rather, the animal model can be used to evaluate multiple investigational drugs for the same targeted disease of condition.
What are the benefits to a sponsor using a qualified animal model in drug development?
A qualified animal model may be used in IND or NDA/BLA submissions, so long as:
- The study is conducted properly (e.g., all procedures and protocols specified in the context of use (COU) are followed).
- The animal model is used for the qualified purpose (i.e., used within the COU).
- At the time of qualification, there is no new information that conflicts with the basis for qualification.
Additionally, the review division will evaluate whether the use of the qualified animal model is suitable for efficacy testing of that particular investigational drug. Integration of qualified animal models into regulatory review can accelerate the drug development and review process.
Is the qualification program only for animal models of chemical, biological, radiological, and nuclear threat agents?
No. The qualification program will consider animal models for etiologic agents for which drug development would require use of the Animal Rule. The Animal Rule can be used for drugs intended to ameliorate or prevent other serious or life-threatening conditions due to other toxic chemical, biological, radiological, or nuclear substances (e.g., emerging virus, snake venom, industrial chemicals) when it would not be ethical to conduct human challenge studies and field trials to study effectiveness are not feasible.
Who evaluates animal model data submitted for qualification?
The scientific evaluation of the data and the qualification recommendation are made by the Qualification Review Team (QRT). This is a multidisciplinary team composed of reviewers assigned from offices within CDER and other FDA centers and offices, as appropriate. The team will have at least one member from each of the disciplines necessary to ensure adequate breadth of subject matter expertise for the proposed animal model to be qualified.
How do the roles of the Animal Model Qualification Program (AMQP) staff and the QRT differ in the qualification process?
The AMQP staff provides assistance related to the AMQP processes and procedures; only the QRT is able to address scientific matters related to the model.
When during animal model development should the qualification process be initiated?
Although the greatest benefit may be obtained when the interactions begin early in model development, submitters may contact the AMQP staff at any stage of model development to discuss their readiness to submit a Letter of Intent (LOI) and initiate the process.
Can a submitter retain intellectual property rights of a qualified animal model?
Qualification of an animal model will not displace intellectual property rights.
How will the information about a qualified animal model be made publicly available?
After an animal model is qualified, CDER will publish a notice of the qualification recommendation in the Federal Register. The final animal model qualification will be published as an attachment to the Qualification Process for Drug Development Tools Guidance. Supporting documents will also be posted.
Who do I contact for more information?
Center for Drug Evaluation and Research (CDER)
Animal Model Qualification Program Team
Center for Biologics Evaluation and Research (CBER)
David Cho, Ph.D.
 All references to drugs include human drugs, therapeutic biological products, cellular and gene therapies, and vaccines.