publicEuropean Medicines Agency (EMA) · European Union · Updated Sep 21, 2026
New ICH M13B Guideline on Bioequivalence for Additional Strengths Biowaiver
Update workflows and SOPs to incorporate the new biowaiver criteria, particularly in regulatory filing processes for applications involving additional strengths of solid oral dosage forms.
LabelingRegulatory Intelligence Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead
verifiedRegulatory action: Regulators
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