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

30 November 2016

ICH Q3C(R6) Guideline reaches Step 4 of the ICH Process

The ICH Q3C(R6) Guideline reached Step 4 of the ICH Process in November 2016 and now enters into the implementation period (Step 5). This most recent maintenance of the ICH Q3C Guideline revises the PDE for Methyl isobutyl...

18 November 2016

Press release ICH MedDRA Management Board meeting in Osaka, Japan, November 2016

The ICH MedDRA Management Board met in Osaka, Japan on November 5-6, 2016 and announces reductions in Subscription Rates for MSSO Subscribers....See the complete press release

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...