The recommendations of this revised Guidance further harmonise 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 authorisation for pharmaceuticals.
The ICH Harmonised Guideline was finalised under Step 4 in July 1997. This document covers the preclinical safety testing requirements for biotechnological products. It addresses the use of animal models of disease, determination of when genotoxicity assays and carcinogenicity studies should be performed, and the impact of antibody formation on duration of toxicology studies.
An addendum was proposed to provide clarification on S6 and an update of the following topics discussed in the original ICH S6 Guideline: species selection, study design, immunogenicity, reproductive and developmental toxicity and assessment of carcinogenic potential. The Harmonised addendum provides further complementary guidance to the S6 Guideline and helps to define the current recommendations and reduce the likelihood that substantial differences will exist among regions.
The addendum reached Step 4 of the harmonisation process in June 2011 and was integrated as part II in the core Guideline that was then renamed S6(R1).
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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 finalised 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)).
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