You will find in this section the recent latest new from the ICH.

19 October 2016

New ICH M10 Guideline in development on Bioanalytical Method Validation

In October 2016, the ICH endorsed a new topic on the validation of bioanalytical methods and study sample analyses in non-clinical and clinical studies. This guideline will provide recommendations on the scientific regulatory...

19 October 2016

New ICH M9 Guideline in development on Biopharmaceutics Classification System (BCS)-based biowaivers

In October 2016, the ICH endorsed a new topic for the development of a new multidisciplinary guideline to address Biopharmaceutics Classification System (BCS)-based biowaivers. This guideline will provide recommendations to...

19 October 2016

ICH E11(R1) draft Guideline reaches Step 2b of the ICH Process

The ICH E11(R1) draft Addendum Guideline on Clinical Investigation of Medicinal Products in the Pediatric Population reached Step 2b of the ICH Process in October 2016 and now enters the consultation period (Step...

31 August 2016

The Q3D Training Modules 8 to 9 available now on the ICH Website

The Q3D Training Modules 8-9 (Module 8: Case Studies; Modules 9: FAQ document) can now be found on the ICH website. The Q3D Guideline aims to provide a global policy for limiting elemental impurities in drug products. The...