Bioanalytical Community

EMA has taken an ICH M10 implementation approach based on a program's stage of development vs  the EMA implementation date of 21January2023 when all validations should comply.  3 other scenarios are outlined:

1) If your development program started shortly before 21Jan23- consider transitioning to ICH M10

2) Program is in phase 3 - ongoing studies may complete against the EMA BMV from 2011. 

3) The nonclinical (GLP) program is complete and assays were run and samples were analyzed preior to 21Jan23, no need to transition or repeat work if the work was performed in compliance with the 2011 EMA BMV

#EMA #ICH_M10_Implementation

Link to guideline

That is very helpful. Thank Mark for sharing the information. What is FDA's approach on ICH M10 implementation?

EMA has taken an ICH M10 implementation approach based on a program's stage of development vs  the EMA implementation date of 21January2023 when all validations should comply.  3 other scenarios are outlined:

1) If your development program started shortly before 21Jan23- consider transitioning to ICH M10

2) Program is in phase 3 - ongoing studies may complete against the EMA BMV from 2011. 

3) The nonclinical (GLP) program is complete and assays were run and samples were analyzed preior to 21Jan23, no need to transition or repeat work if the work was performed in compliance with the 2011 EMA BMV

#EMA #ICH_M10_Implementation

Link to guideline