20 March 2019

The ICH M10 draft Guideline on Bioanalytical Method Validation reached Step 2b of the ICH Process on the 26 February 2019 and now enters the consultation period. The M10 draft Guideline provides recommendations for the validation of bioanalytical assays for chemical and biological drug quantification and their application in the analysis of study samples, with a view to improve the quality and consistency of the bioanalytical data in support of the development and market approval of both chemical and biological drugs.

You may provide comments on the ICH M10 draft Guideline by e-mailing the ICH Secretariat (step2comments@ich.org), and please note that stakeholders from ICH regions are encouraged to submit their comments to their respective Regulatory Authorities. More details are available under the Public Consultation page.

Additionally, a Step 2 Presentation has been developed by the M10 Expert Working Group.

Both the ICH M10 draft Guideline and the ICH M10 Presentation can be downloaded on the ICH website here.