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

19 January 2017

The Q3C(R6) Step 4 presentation available now on the ICH Website

The Q3C Guideline recommends the use of less toxic solvents in the manufacture of drug substances and dosage forms, and sets pharmaceutical limits for residual solvents (organic volatile impurities) in drug products. In 2014, the...