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

14 October 2010

Health Canada recognises all ICH Q4B pharmacopoeial texts

An important landmark has been achieved with the addition of a general statement indicating interchangeability pertinent to Health Canada in all Q4B topic-specific annexes

30 September 2010

Updated MedDRA Guidance available with the release of MedDRA version 13.1

The ICH M1 "Points to Consider" Working Group updated the "MedDRA Term Selection" and the “Data Retrieval and Presentation” documents.

23 September 2010

Follow in details the main decisions taken by the ICH governing body

A comprehensive report of the last meeting of the ICH Steering Committee and its Working Groups that was held in Tallinn on June 5-10 2010 is now available on the ICH website under the ICH meeting reports. This adds to the...

14 September 2010

Newly released Guidelines

In September 2010, new ICH Step 4 Tripartite Harmonised Guidelines have been released for implementation:ICH E16: Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure and Format of...