USA – FDA Consults on ICH Safety Data, Bioanalytical Method Validation Guidelines

The US Food and Drug Administration (FDA) on Wednesday issued two draft International Council for Harmonisation (ICH) guidelines covering safety data collection and bioanalytical method validation for public consultation.
 
The consultation on the guidelines, which correspond to ICH’s E19 Optimisation of Safety Data Collection and M10 Bioanalytical Method Validation, will be open for two months. Both guidelines reached Step 3 of the ICH process earlier this year and will undergo consultations by each ICH member before being adopted by the harmonization body.
 
According to ICH, regulators in Brazil, Europe, Japan and Taiwan have already opened consultations on the E19 document, while regulators in Brazil, Europe, Canada, Korea, Japan, China, Switzerland and Taiwan have begun consultation on the M10 guideline.
 
Speaking at an event in April, FDA officials said the E19 guideline is expected to reach Step 4 in June 2021 and the M10 guideline is expected to reach Step 4 by November 2020.
 
While both guidances are presented in ICH’s original format for the consultation, FDA says the final versions will be reformatted to meet its good guidances practices and style requirements…