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

16 December 2010

New ICH Guideline Set to Replace Current E2C(R1) Guideline

The ICH Steering Committee has approved the development of a new ICH E2C(R2) Guideline to replace the current ICH E2C(R1) Guideline “Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs”.

11 November 2010

Further Opening to Non-ICH Regions

The ICH Steering Committee has agreed to open ICH technical working groups to active participation from experts from non-ICH member regions and countries of the ICH GCG. Members, who include Australia, Brazil, China, Chinese...

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.