M3 Nonclinical Safety Studies
M3(R2) Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals
The recommendations of this revised Guidance further harmonize the nonclinical safety studies to support the various stages of clinical development among the ICH regions. The present Guidance represents the consensus that exists regarding the type and duration of nonclinical safety studies and their timing to support the conduct of human clinical trials and marketing authorization for pharmaceuticals.
Date of Step 4: 11 June 2009
Status: Step 5
Guidelines (Click the links below for complete guidelines)
Endorsed Documents (Click the links below for complete guidelines)
WG Presentations / Trainings (Click the links below for complete guidelines)
M3(R2) Q&As (R2) Questions & Answers: Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals
The complexity of the M3(R2) Guidance, its broader scope, and numerous changes in recommendations from the M3(R1) Guidance have generated questions that impact its successful implementation.
To clarify the key issues of this document, the Steering Committee has endorsed the establishment of a M3(R2) Implementation Working Group (IWG), with the objective of developing the Q&As.
The document with the first set of Q&As addressing Limit Dose for Toxicity Studies, Metabolites and Reversibility of Toxicity was finalized under Step 4 in June 2011.
In December 2011, a second set of Q&As addressing Combination Drug Toxicity Testing was approved under Step 4 by the Steering Committee, and included in the Q&A document (M3(R2) Q&As (R1)).
In March 2012, an additional question on Limit Dose for Toxicity Studies and 4 additional sections addressing Safety Pharmacology, Exploratory Clinical Trials, Reproductive Toxicity and Juvenile Animal Studies were approved under Step 4 by the Steering Committee, and included in the Q&A document (M3(R2) Q&As (R2)).
Date of Step 4: 15 June 2011
Status: Step 5
Questions & Answers (Click the links below for complete guidelines)
M3(R2) Q&As (R2) Questions & Answers
Endorsed Document (Click the links below for complete guidelines)
M3(R2) Q&As (R2) Concept Paper
*These Guidelines Belongs to ICH website.
