Biopharmaceutics Classification System (BCS) Biowaivers


Regulatory Authorities participating in the IPRP Bioequivalence Working Group for Generics were surveyed for their requirements for biowaivers based on the Biopharmaceutics Classification System (BCS). The results of the comparison of criteria for BCS biowaivers among the participating regulators and organisations were published in the Journal of Pharmacy and Pharmaceutical Sciences on 25 January 2018.


Survey of the Regulatory Requirements for BCS-Based Biowaivers for Solid Oral Dosage Forms by Participating Regulators and Organisation of the International Generic Drug Regulators Programme


To ensure that the relevant information for a BCS biowaiver is consistently taken into account during assessment, a template for a BCS Biowaiver Assessment Report was developed for use by Members. The Members of the Working Group envisage that this BCS Biowaiver Assessment Report template will also be of benefit to applicants and the broader regulatory community and have decided to make the BCS Biowaiver Assessment Report template available on the IPRP website.


The following Word version is provided in addition to the PDF version. Non-IPRP member regulators may implement these documents within their own responsibility. IPRP is not responsible for any contents of these documents implemented by non-IPRP member authorities.

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