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

30 November 2016

ICH Q11 draft Q&A document reaches Step 2b of the ICH Process

The ICH Q11 Questions and Answers (Q&As) on the Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities), regarding the selection and justification of starting materials,...

30 November 2016

ICH E6(R1) Integrated Addendum reaches Step 4 of the ICH Process

The Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice (GCP) reached Step 4 of the ICH Process in November 2016. The 1996 ICH Guideline on GCP is one of the most significant achievements of the ICH process,...

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