Which of the following is NOT a requirement for generic drug approval?

Generic drugs are required to meet certain criteria for approval, but they do not need to undergo the same clinical trials as brand-name drugs. This is because generic drugs are required to demonstrate bioequivalence with the brand-name counterpart, which means that they must show that they are absorbed into the bloodstream at the same rate and extent. This is conducted through specific bioequivalence studies rather than the extensive clinical trials that original brand-name drugs undergo to establish safety and efficacy.

The requirement for similar dosage forms ensures that the generic version can be used in the same manner as the brand-name drug. Additionally, demonstrating comparable effectiveness is essential, as the generic must meet the same standards for safety and efficacy, despite not having to conduct the entire suite of original clinical trials.