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

31 August 2016

The Q3D Training Modules 8 to 9 available now on the ICH Website

The Q3D Training Modules 8-9 (Module 8: Case Studies; Modules 9: FAQ document) can now be found on the ICH website. The Q3D Guideline aims to provide a global policy for limiting elemental impurities in drug products. The...

5 August 2016

ICH M4(R4) Guideline reaches Step 4 of the ICH Process

The revised version of the ICH M4(R3) Guideline on the overall organisation of the CTD including the Granularity Document reached Step 4 of the ICH Process in June 2016 and now enters the implementation period (Step 5). The...

14 July 2016

ICH M4E(R2) Guideline reaches Step 4 of the ICH Process

The revised version of the ICH M4E(R1) Guideline on Enhancing the Format and Structure of Benefit-Risk Information in ICH reached Step 4 of the ICH Process in June 2016 and now enters the implementation period (Step 5)....

20 July 2016

Press release ICH MedDRA Management Board meeting in Lisbon, Portugal, June 2016

The ICH MedDRA Management Board met in Lisbon, Portugal on June 11-12, 2016 where ICH concluded its internal process for the award of a new 7-year contract for the MedDRA Maintenance and Support Services Organization...