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 su ...

5. Clear policy on regulatory requirements, system and procedures is critical for efficient development and approval of new drug through generation of adequate non-clinical and clinical data and their evaluation in transparent and scientific manner for assessment of safety and effectiveness of the new drug. 6. Such policy will not only enhance the public assurance that any new drug approved for ma ...

3. As per the rules, for manufacture or import of new drugs, the manufacturers/ importer are required to obtain manufacturing/ import permission from CDSCO under the New Drugs and Clinical Trials Rules, 2019 before Licencing the product under the Drugs Rules, 1945. 4. Robust system for evaluation of applications of clinical trial and new drug which contains data of Chemistry, Manufacture, Control ...