After the NDA is accepted the various section of the application should undergo concurrent review. The non-clinical and chemical data should be reviewed in consultation with subject expert committee as per the standard procedures. 13.With the increasing globalization of drug development, it has also become important that data from global clinical trials (GCTs) can be accepted as the primary source of evidence to support marketing approval of new drug. 14.CDSCO recognize the global clinical trial data for considering the marketing approval of New drug under the provisions of the New Drugs and Clinical Trials Rules, 2019. 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.