What is the Origin of ICH M3(R2)?

The ICH was formed in 1990 to harmonize technical requirements across major global regulatory bodies, including the European Union, Japan, and the United States. The "M3" designation places it in the multidisciplinary category, while "(R2)" signifies that it is the second revision of the original guideline. Its purpose is to standardize drug development timelines and reduce the unnecessary use of animals in preclinical testing.

What is the Mechanism of ICH M3(R2)?

The guideline functions by recommending the type and timing of non-clinical safety studies, such as toxicology and toxicokinetics, relative to the proposed duration and scope of the clinical trial phase. For instance, chronic animal toxicity studies must be completed before a long-term human trial can begin. This structured approach ensures a stepwise assessment of pharmacological risk, moving from minimal human exposure to widespread patient use only after sufficient safety data is generated.

ICH M3(R2)

Meaning

ICH M3(R2) is a multidisciplinary regulatory guideline established by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. It provides international standards for the non-clinical safety studies required to support the various stages of human clinical trials and eventual marketing authorization of a pharmaceutical. This document ensures that a drug’s toxicity profile is adequately characterized before human exposure.