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EMA (EU)
GUIDANCE FINAL
ICH M13B guideline on bioequivalence for immediate-release solid oral dosage forms - additional strengths biowaiver - Step 5
Published: 9/21/2026Detected: 9/21/2026

Summary preview

Provides an EMA/ICH-endorsed framework for granting bioequivalence (BE) waivers for additional strengths of immediate-release solid oral products when in vivo BE (or efficacy/safety bridging) exists for at least one…

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clinical
quality
manufacturing
safety
labeling
#bioequivalence
#biowaiver
#additional strengths
#immediate-release
#solid oral dosage forms

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