The recent ICH Harmonised Guideline M10 Bioanalytical Method Validation and Study Sample Analysis, adopted by ICH 24 May 2022, will be implemented by PQT/MED effective 1 May 2023.
The M10 guideline represents a harmonisation and update of the regulatory requirements for bioanalytical method validations and for the application of bioanalytical methods for study sample analysis relative to the requirements outlined in earlier US FDA and EMA bioanalytical validation guidelines.
The M10 guideline has been implemented by national regulatory authorities (NRAs) such as the EMA (effective 21 January 2023), Health Canada (20 January 2023), Swissmedic (25 May 2022), and the US FDA (7 November 2022), and is in the process of implementation by other NRAs.