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

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...

31 August 2018

The ICH M9 draft Guideline presentation available now on the ICH website

The ICH M9 draft Guideline on Biopharmaceutics Classification System-based Biowaivers reached Step 2b of the ICH Process in June 2018 and has entered the public consultation period. Additionally, a Step 2 Presentation has...

21 August 2018

The ICH E9(R1) Step 2 Training Material available now on the ICH website

The ICH E9(R1) Step 2 Training Material was produced by the ICH E9(R1) Expert Working Group to accompany the Draft ICH E9(R1) Addendum, and is intended to support the scientific community in the comprehension of a new framework...