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0:00
Hello. I'm Masamitsu Honma,
the former director
general of NIH Japan.
I was previously the
head of the division
of genetics and
mutagenesis until 2020.
My expertise is in
genetic toxicology,
and I've contributed to
the development of ICH
guidelines for over 30 years.
Today I'll be discussing
the ICH S2 guideline
on genotoxicity.
0:34
Here is the structure
of my presentation.
I will begin with a
brief overview of
the original ICH genotoxicity
Guidelines S2A and S2B.
Then, I'll focus on the revised
Tobago S2(R1)
introduced in 2011.
I'll explain its key changes,
and benefits, and then
summarize my conclusions.
1:05
To clarify, ICH stands for
the International Council
for Harmonisation of
technical requirements for
pharmaceutical for human use.
Regulatory authorities
and experts
from the pharmaceutical
industry meet together,
and discuss about scientific
and technical aspects of
pharmaceutical
product registration
and develop ICH guidelines.
The ICH was launched in 1990
and the S2A guidance on
specific aspects of
regulatory genotoxic test
for pharmaceuticals
was released in 1995.
It provided detailed
guidance for invitro and
in vivo Genotoxicity tests
along with the glossary
of related terms.
In 1997, the S2B guideline
standard batteries
