The Biologics License Application (BLA) in Common Technical Document (CTD) Format

The purpose of a biological license application (BLA) is to submit documentation that demonstrates the safety and efficacy of the biologic for which a marketing application is being sought. In addition to safety and efficacy data, information regarding the chemistry, manufacturing, and control (CMC) is also submitted. BLAs are submitted in a format known as the Common Technical Document (CTD). The CTD is organized into five modules. Module 1 is country or region specific and contains the information that is unique to a region. Module 2 contains summary documents for Modules 3–5. Module 2 is similar to the Expert Report for those who are familiar with the old format used in Europe. Module 3 is called the Quality Module and contains all of the CMC information for the new product. Nonclinical data are found in Module 4, and clinical data are presented in Module 5.