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# ICH M9 Biopharmaceutics Biowaivers Q&A Guidance
- URL: https://www.fdaweb.com/ich-m9-biopharmaceutics-biowaivers-q-a-guidance/
- Published: 2023-05-03T12:00:00.000Z
- Updated: 2026-09-14T18:29:11.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154354

FDA has published the International Council for Harmonization M9 *Biopharmaceutics Classification System-Based Biowaivers Questions and Answers* guidance. The [document](https://www.fda.gov/media/167742/download?ref=fdaweb.com) has questions and answers covering the Introduction/Scope, Biopharmaceutics Classification of the Drug Substance, Eligibility of a Drug Product for a BCS-Based Biowaiver, and an annex with questions and answers linked to the respective sections of the M9 guidance.