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

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...

12 July 2016

ICH S9 Q&As reaches Step 2b of the ICH Process

The Questions and Answers Document of the ICH S9 Guideline on Non Clinical Evaluation for Anticancer Pharmaceuticals reached Step 2b of the ICH Process in June 2016 and now enters the consultation period (Step 3). The ICH...