Biowaivers are waivers of clinical bioequivalence studies which are often required for generic drugs or for small changes in drug products that evolve during drug development to ensure equivalence with dosage forms proven to be safe and effective. The application of the biowaivers thought has been prolonged to approval of certain APIs pertaining to BCS class 1 formulated in immediate release dosage form. Biowaivers typically save time and cost compared to clinical trials. Although typically mentioned, BCS-based biowaivers are still hardly used probably as a result of doubts on each, pharmaceutical firms and restrictive authorities. Substantial changes of biowaivers dossiers and specific valuations contribute to the impression that a standard understanding is lacking on a positive use of the BCS thought to support biowaivers. It is intended to reach an optimal and harmonized application of biowaivers among different regulatory authorities of The United States Food and Drug Administration (FDA), European Medicines Agency (EMEA) and Japanese Pharmaceuticals and Medical Devices Agency (PMDA), and World Health Organization (WHO). The article here summarizes and compares the possible differences and similarities between various regulatory bodies regarding BCS based biowaivers.
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