15.However, detailed guidance documents should be prepared providing the requirements and adequacy of global clinical data that can be considered for approval of any new drug in the country in both the cases where India was one of the participating countries in the global clinical trial or in cases where India was not a participating country. 16.The sponsor intending to submit NDA to CDSCO for mar ...

POLICY ON POST-APPROVAL STUDIES 1. Post-approval studies may be required to provide additional information on the efficacy, safety, and use of the drug in populations more diverse than included in the clinical trials conducted prior to approval of the new drug in accordance with the provisions of the rules. 2. Necessary guidance documents should o be developed to provide the extent of requirements ...