Drug Development Tools are methods, materials, or measures that have the potential to facilitate drug development. Examples of these tools may include, but are not limited to: a biomarker used for clinical trial enrichment, a clinical outcome assessment (COA) used to evaluate treatment benefit, or a disease specific animal model used for efficacy testing under the Animal Rule. Qualification is a regulatory decision that means that within a stated context of use (COU), a Drug Development Tool has been demonstrated to reliably support a specified manner of interpretation and application in drug development. Qualification process of these development tools, is different in some way or other in various countries.