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

23 November 2018

Press release ICH MedDRA Management Committee meeting in Charlotte, NC, USA, November 2018

The MedDRA Management Committee noted that 1 March 2019 will mark the 20 year anniversary of the first release of MedDRA. Since its inception in 1999, MedDRA has experienced remarkable growth as a true international standard with...

23 November 2018

Press release ICH Assembly meeting in Charlotte, NC, USA, November 2018

The International Council for Harmonisation (ICH) met in Charlotte, NC, USA on 10-15 November 2018. Three years on from the reform of ICH, all organisational changes have been implemented, with the Charlotte meeting being...

25 October 2018

The ICH Q3C(R7) Guideline and Q3C Support Documents available now on the ICH website

The ICH Q3C(R7) Guideline, which is the result of an error correction of the Permitted Daily Exposure (PDE) for ethyleneglycol in the ICH Q3C(R6) Guideline, and the Q3C Support Documents 1, 2 and 3, which contain the summaries of...

18 October 2018

The ICH S11 draft Guideline presentation available now on the ICH website

The ICH S11 draft Guideline on Nonclinical Safety Testing in Support of Development of Paediatric Medicines reached Step 2b of the ICH Process in September 2018 and now enters the consultation period. Additionally, a Step...