As the December of 2022, half year after ICH published the finalized M10 guidance, only EMA announced the adoption of ICH from Jan. 21st, 2023. FDA published notice of the finalized ICH M10. But FDA did not layout the plan/process to adopt the long-waited M10.
It is not surprising that it will take years for M10 to be fully implemented. The pharmaceutical industry need years of effort and tons of resources to improve their facility/SOP/documentations to be complied. So for the next several years the current effective guidance of FDA and EMA would be still considered acceptable by authorities.
Some significant improvements of ICH M10 include:
1: detailed description of comparative bioavailablity/bioequivalence: what can and can not do with the BA/BE study, how to document and report BA/BE study.
2: More examples for specific situations : when to do cross/partial validation; what to do with analyte that are also endogenous molecules; what need to be documented, etc
3: ICH encourage the 3R(reduce, refine and replace). If any new technology are in line with 3R, industry should justify it fit for purpose and use it.
reference:
ICH M10 (2022) BIOANALYTICAL METHOD VALIDATION AND STUDY SAMPLE ANALYSIS
FDA(2018): Bioanalytical Method Validation Guidance for Industry
EMA(2012): Guideline on bioanalytical method validation