9 March 2012

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 and Juvenile Animal Studies. An additional Q&A was also added in the already existing section on Limit Dose for Toxicity Studies. These new Q&As were added to the existing document dated December 2011 and the Q&A document was subsequently renamed R2.

The updated M3(R2) Q&A document is available for download from the M3 Section on the Multidisciplinary Guideline page.