For generic drugs with active ingredients on the list of post marketing surveillance, if the product is still within the pharmacovigilance period, local clinical trial reports (including bridging study) meeting the standards that its reference was provided in the original license-granted the NDA should be submitted. If local clinical trial reports (including bridging study) were not provided in the dossier for the approval of this new drug, one of the following documents should be submitted, (1) BE study report, or (2) BA study and clinical trial reports. For generic drugs which pharmacovigilance period has expired, either (1) BE study reports, or (2) BA study and clinical trial reports should be submitted

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