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

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...

21 June 2017

The revised ICH Articles of Association, Rules of Procedure and Standard Operating Procedures are now available on ICH website

At the ICH meeting in Montreal, Canada, on 27 May to 1 June 2017, the ICH Assembly and ICH Management Committee made some revisions to the Articles of Association, Rules of Procedure and Standard Operating Procedures for Working...

19 June 2017

Press release ICH Assembly meeting in Montreal, Canada, May/June 2017

The International Council for Harmonisation (ICH) met in Montreal, Canada on 27 May to 1 June 2017. Among other decisions, the ICH Assembly approved the China Food and Drug Administration (CFDA) as a new Regulatory Member, and...