The Center for Drug Evaluation (CDE) has developed the Module-Based Rolling Review mechanism to assist applicants in identifying possible deficiencies of the dossier(s) in the development stage and improves the quality of their submission.The concept of Module-Based Rolling Review is to submit modules of the Common Technical Document (CTD) dossier for pre-assessment rather than submitting full registration dossiers for review. Applicants can apply for a Module-Based Rolling Review of the technical dossier of one or more modules before the registration.