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

23 January 2017

The M1 PtC Concept Paper available now on the ICH Website

In November 2016, the Board approved the Working Group’s proposal to develop a companion document to the PtC documents, available in English and Japanese, which would provide more detailed guidance, examples, and “Questions and...

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,...