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

23 January 2017

The 2017 ICH and MedDRA Work Plans available now on the ICH Website

In November 2016, the ICH Assembly approved the 2017 ICH Work Plan and Multi-annual Strategic Plan, as well as the 2017 MedDRA Work Plan. These documents provide objectives and timelines in respect of the goal of the ICH...

23 January 2017

The MedDRA MC Rules of Procedures available now on the ICH Website

In November 2016, the ICH MedDRA Management Committee (MC) approved the MedDRA MC Rules of Procedures developed to provide guidance and interpretation in respect of the provisions of the Articles of Association relating to the...

23 January 2017

The M4(R4) presentation available now on the ICH Website

The Common Technical Document (CTD) is organised into five modules, including as an Annex the Granularity document that provides guidance on document location and paginations. In June 2016, this Annex was revised to add Module 2...

23 January 2017

The M1 PtC Concept Paper available now on the ICH Website

In November 2016, the Board approved the Working Group’s proposal to develop a companion document to the PtC documents, available in English and Japanese, which would provide more detailed guidance, examples, and “Questions and...