by Gail McGrew, Science Writer
The new ICH M10 Bioanalytical Validation Guideline provides global guidance that changes how bioanalytical validation and sample analysis will be undertaken in industry. Finalized May 24, 2022, and currently pending adoption by regulatory authorities around the world, it advances the industry from multiple regional sets of bioanalytical guidelines to a single harmonized document.
In 2016, The ICH (International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use) formed a working group to address a growing concern that guidelines and regulations for bioanalytical method validation and sample analysis were diverging among individual countries. These regional differences in regulatory expectations made global drug submissions more complex, and the M10 guideline was developed to remedy this situation.