Minoxidil End of procedure: 11/10/2011 Date of publication: 30/01/2012

In December 2011, the ICH M3(R2) Implementation Working Group finalised under Step 4 of the ICH Process an additional set of Questions and Answers addressing Combination Drug Toxicity Testing.

A comprehensive report of the last ICH meeting that was held in Seville, Spain on 5 - 10 November 2011 is now available on the ICH website under the SC Reports page.

At its meeting in Seville in November 2011, the ICH Quality Implementation Working Group finalised three Points to Consider topics covering: Role of Models in Quality by Design (QbD); Design Space; and Process Validation/Continuous Process Verification.

At their meetings in Seville, in November 2011, the ICH E2B(R3) and M8 working groups finalised further documentation related to the development of ICH electronic standards.

The ICH S2(R1) Guideline on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use reached Step 4 of the ICH Process in November 2011 and now enters the Implementation phase (Step 5).

The International Conference on Harmonisation (ICH) Steering Committee (SC) and its working groups met in Seville, Spain from 5 - 10 November 2011.

The MedDRA Management Board met in Seville, Spain on 5 - 6 November 2011.

The ICH M1 "Points to Consider" Working Group updated the “MedDRA Term Selection” and the “Data Retrieval and Presentation” documents to provide best practice approaches for data entry (coding) and data retrieval/analysis for MedDRA version release 14.1.

The E2B(R3) Expert Working Group has finalised the Step 2 ICH Implementation Guide for Electronic Transmission of Individual Case Safety Reports (ICSRs), Data Elements and Message Specification which includes the key parts of the updated E2B(R3) Guideline.