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

11 July 2016

ICH E17 Guideline reaches Step 2b of the ICH Process

The ICH E17 Guideline on Multi-Regional Clinical Trials reaches Step 2b of the ICH Process in June 2016 and now enters the consultation period (Step 3). This new ICH Guideline is proposed to provide guidance on general principles...

27 June 2016

Press release ICH Assembly meeting in Lisbon, Portugal, June 2016

The International Council for Harmonisation (ICH) met in Lisbon, Portugal, 11-16 June 2016, bringing together regulators and industry from around the world. Building on the objective to establish itself as a truly global platform...

11 June 2016

The Question and Answer document on Membership and Observership

A Question and Answer (Q&A) document on Membership and Observership can now be found on the ICH website. The Q&A document aims to address questions of potential applicants interested in ICH Membership and Observership. ...

19 May 2016

ICH S3A Q&As reaches Step 2b of the ICH Process

The Questions and Answers Document of the ICH S3A Guideline on Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure reached Step 2b of the ICH Process in May 2016 and now enters the consultation period (Step...