EMA publishes Overview of Comments received on ICH M13B Guideline on Bioequivalence

As previously reported, the European Medicines Agency (EMA) published the "ICH Guideline M13B on bioequivalence for immediate release solid oral dosage forms - additional strengths" on its website for public consultation in early April 2025. The deadline for comments was set for 9 July 2025 (Step 2b).

The "guideline is intended to provide recommendations on obtaining waivers of bioequivalence (BE) studies for one or more additional strengths of a drug product in an application where in vivo BE has been demonstrated for at least one of the strengths. The guideline is applicable during both development and post-approval phases of orally administered immediate release (IR) solid dosage forms designed to deliver drugs to the systemic circulation, such as tablets, capsules, and granules/powders for oral suspension."

The overview of comments (EMA/CHMP/ICH/85092/2025) published on the EMA website on 25 July 2025 documents feedback from industry, academia, and professional associations, including contributions from:

• Board on Cooperation with the Economic Environment, Committee on Therapeutics and Drug Sciences of the Polish Academy of Sciences
• Medicines for Europe
• Network Bioavailability & Biopharmaceutics of the European Federation for Pharmaceutical Sciences (EUFEPS)
• House of Pharma & Healthcare
• German Pharmaceutical Society (DPhG)
• Frankfurt Foundation Quality of Medicines (FFQM)
• as well as several pharmaceutical companies

Key topics addressed in the comments include:

• Requirements for the calculation and rounding of values
• Definition and application of f2 factors in the similarity assessment of dissolution profiles
• Flexibility in the selection of batches for in vitro comparisons
• Requirements for analytical validation, particularly in non-QC media
• Clarifications regarding variability and the bootstrap methodology
• Refinements to existing definitions of key terms and calculation parameters
• Inclusion of additional terminology definitions

The submitted comments are now being reviewed and assessed by the ICH M13B Expert Working Group (EWG) as part of Step 3 of the ICH process.

The PDF document containing the comment overview is available here.