APPROVAL OF GENERICs
For the approval of a generic drug, the performance of own preclinical and clinical trials can be waived under certain conditions. Of utmost importance, however, is consistency with the reference drug. The generic drug must be essentially the same as the reference drug, i.e. the same active ingredient, dosage form and bioavailability.
In addition to the documents demonstrating substantial comparability, the applicant must submit the administrative data, pharmaceutical quality data, and expert summary reports.