PRESENTATION AND SUBMISSION OF APPLICATION 1. In order to make regulatory review process as efficient for CDSCO as possible, the submission of applications for approval of clinical trials and new drugs to CDSCO ensuring conciseness, correctness, consistency and clarity. 2. A clear well-presented submission facilitates the evaluation process in a timely manner, whereas, a difficult-to-evaluation submission will require more time to correct the deficiencies before actual evaluation can proceed leading to delay in taking final decision on the application. 3. Thus, in order to evaluate the applications of new drugs and clinical trials applications under the ND & CT rules should be submitted in CTD format only.