Drug development

Bioequivalence and the scope of M13A

M13A covers immediate-release oral solid forms delivering drug systemically. In the EU it supersedes specified earlier EMA provisions for non-replicate designs, not all bioequivalence guidance.

Sources and scope checked: 3 October 2026 · Guide version 1

Scope: Check biowaivers, modified release and product- or market-specific requirements separately.

View my progress Practise in the lab

Prepare your evidence before a decision

Mark the prompts for which you have organised evidence. Completion tracks preparation; it does not establish product or site compliance.

Identify dosage form, route and target market.
Justify comparator, design and fasting or fed conditions.
Review the analysis plan and acceptance criteria before interpreting results.
Document deviations, missing data and limits of inference.

You can use and print this checklist without electronic saving.

Ticks are saved only in this browser. No documents or patient data are sent. The download includes prompt status and source links.

Bioequivalence and the scope of M13A

Prepare your evidence before a decision

Continue to practice