Effective January 25, 2025, the ICH Guideline M13A introduces a globally harmonized framework for bioequivalence (BE) of immediate-release (IR) solid oral dosage forms. This new standard aligns regulatory expectations across major markets and complements existing guidelines like the EMA’s “Guideline on the Investigation of Bioequivalence” (CPMP/EWP/QWP/1401/98 Rev. 1).

Key Highlights of ICH M13A:
– Study Design: Standardized crossover studies for pharmacokinetic evaluation.
– Statistical Criteria: Unified acceptance range for BE (90% confidence intervals within 80-125%).
– Biowaivers: Provisions for BCS Class I and III drugs.
– Harmonization: Consistent requirements across ICH regions.

Industry Impact:
ICH M13A simplifies global drug development, reducing redundancy and costs while maintaining rigorous standards.
– Global Consistency: Aligns with EMA guidelines but introduces additional clarity for multi-region compliance.
– Efficiency Gains: Reduces region-specific studies and accelerates market entry.
– Regulatory Predictability: Simplifies global compliance for BE studies.
– Biowaiver Opportunities: Encourages in vitro methods to reduce in vivo testing.

ICH M13A marks a significant step in harmonizing BE standards, fostering efficiency and innovation.
Proactive adaptation will ensure a smooth transition to this unified regulatory framework.

We at Billev Pharma East can offer you support in successful conduct of BE trials, from design, monitoring to statistical evaluation. Our team of experts can guide you from the planning stage onwards and based on vast experiences ensure greater success in conduct of BE trials.

Access the full scientific guidance via https://www.ema.europa.eu/en/ich-guideline-m13a-bioequivalence-immediate-release-solid-oral-dosage-forms-scientific-guideline