Biopharmaceutics Classification System (BCS) Biowaiver Assessment Report Template

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Regulatory Authorities participating in the IGDRP Bioequivalence Working Group often have differing requirements for biowaivers based on the Biopharmaceutics Classification System (BCS).

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 IGDRP website.

Biopharmaceutics Classification System (BCS) Biowaiver Assessment Report template (PDF version 1)

The following word version is provided as supplemental to the PDF version above.  Non-IGDRP member regulators may implement these documents within their own responsibility. IGDRP is not responsible for any contents of these documents implemented by non-IGDRP member authorities.

Biopharmaceutics Classification System (BCS) Biowaiver Assessment Report template (Word version 1)