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

Summary preview

Provides an ICH/EMA framework to justify bioequivalence (BE) waivers for additional strengths of immediate-release solid oral products when BE/efficacy-safety has been shown for at least one strength.

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clinical
manufacturing
quality
safety
labeling
#ICH M13B
#bioequivalence
#biowaiver
#immediate-release
#solid oral dosage forms

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