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

19 January 2017

The Q3C(R6) Step 4 presentation available now on the ICH Website

The Q3C Guideline recommends the use of less toxic solvents in the manufacture of drug substances and dosage forms, and sets pharmaceutical limits for residual solvents (organic volatile impurities) in drug products. In 2014, the...

12 January 2017

ICH Reflection on “GCP Renovation”: Modernization of ICH E8 and Subsequent Renovation of ICH E6

ICH Consults with Stakeholders on Plan to Modernise Global Good Clinical Practice Guidance

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,...