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

17 November 2016

Press release ICH Assembly meeting in Osaka, Japan, November 2016

The International Council for Harmonisation (ICH) met in Osaka, Japan on 5-10 November 2016. As part of the objective to extend its global outreach, ICH is pleased to welcome the Agência Nacional de Vigilância Sanitária (ANVISA)...

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...