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

10 May 2012

ICH Q11 reaches Step 4 of the ICH Process

The ICH Q11 Guideline on Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) reached Step 4 of the ICH Process on 1 May 2012 and now enters the Implementation phase (Step...

3 May 2012

Additional E14 Q&As available on the ICH website

In April 2012, the ICH E14 Implementation Working Group (IWG) finalised under Step 4 of the ICH Process four additional Questions and Answers addressing Sex Differences, Incorporating New Technologies, Late Stage Monitoring...

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...