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

2 April 2012

Updated MedDRA Guidance available for MedDRA version 15.0

The ICH M1 "Points to Consider" Working Group updated the "MedDRA Term Selection" and the “Data Retrieval and Presentation” documents.

9 March 2012

Additional M3(R2) Q&As available on the ICH website

In March 2012, the ICH M3(R2) Implementation Working Group finalised under Step 4 of the ICH Process an additional set of Questions and Answers addressing Safety Pharmacology, Exploratory Clinical Trials, Reproductive Toxicity...

2 March 2012

ICH E2C(R2) reaches Step 2 of the ICH Process

The ICH E2C(R2) Guideline on Periodic Benefit-Risk Evaluation Report reached Step 2 of the ICH Process in February 2012 and now enters the consultation period (Step 3).The purpose of this revised guidance is to ensure that the...

11 January 2012

M3(R2) Q&As on Combination Drug Toxicity Testing available on the ICH website

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. This new section was added to the...