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

22 June 2018

Press release ICH Assembly meeting in Kobe, Japan, June 2018

The International Council for Harmonisation (ICH) met in Kobe, Japan on 2 – 7 June 2018. In one of the remaining steps of implementing the 2015 reforms of ICH, the Assembly elected additional members to the Association’s...

22 June 2018

Press release ICH MedDRA Management Committee meeting in Kobe, Japan, June 2018

The MedDRA Management Committee noted significant achievements in supporting the global expansion of MedDRA use, in accordance with the five-year strategic plan. In recent months, the MSSO, with the support of ICH, has provided...

3 June 2018

ICH Q3D(R1) revision reaches Step 2b of the ICH Process

The ICH Q3D(R1) Revision of the ICH Q3D Guideline for Elemental Impurities reached Step 2b of the ICH Process in May 2018 and now enters the consultation period. The ICH Q3D(R1) Revision is focused on an error correction in...

30 April 2018

The ICH S9 Q&As reaches Step 4 of the ICH Process

The ICH S9 Q&As on Nonclinical Evaluation for Anticancer Pharmaceuticals reached Step 4 of the ICH Process in April 2018 and now enters into the implementation period (Step 5). This new Q&As is proposed to facilitate...