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

4 September 2017

ICH S5(R3) revised Guideline reaches Step 2b of the ICH Process

The ICH S5(R3) on Detection of Toxicity to Reproduction for Human Pharmaceuticals reached Step 2b of the ICH Process in August 2017 and now enters the consultation period.Since the implementation of the previous version of the...

14 August 2017

ICH Training Pilot Programmes Available

At the Osaka 2016 meeting, the ICH Management Committee endorsed a Pilot Programme for 2017 in which the ICH Training Subcommittee would partner with a small group of training providers to organise and deliver high quality...

26 July 2017

New ICH E19 Guideline in development on Optimisation of Safety Data Collection

In November 2016, the ICH endorsed a new topic on Optimisation of safety data collection. This guideline will provide a harmonised guidance on when it would be appropriate to use a targeted approach to safety data collection in...

21 June 2017

ICH M7(R1) Addendum reaches Step 4 of the ICH Process

The ICH M7(R1) Addendum reached Step 4 of the ICH process in May 2017 and now enters into the implementation period (Step 5). To complement the harmonised ICH M7 Guideline, an Addendum has been developed to summarise known...