Presentation on M7 - ICH
Presentation on M7 - ICH
Presentation on M7 - ICH
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<strong>ICH</strong> <strong>M7</strong> Guideline <strong>on</strong> Mutagenic Impurities<br />
History (c<strong>on</strong>tinued)<br />
2007<br />
o<br />
o<br />
2008<br />
o<br />
o<br />
CHMP Guideline <strong>on</strong> the Limits of Genotoxic Impurities effective January<br />
2007.<br />
CHMP Q&A document generated based <strong>on</strong> industry questi<strong>on</strong>s and EMA<br />
answers<br />
FDA Draft Guidance for Industry. Genotoxic and Carcinogenic Impurities<br />
in Drug Substances and Products: Recommended Approaches.<br />
EMA letter requesting evaluati<strong>on</strong> of sulf<strong>on</strong>ate esters in all marketed<br />
products<br />
2009-10<br />
o<br />
o<br />
o<br />
November 2009 – C<strong>on</strong>cept paper issued and <strong>ICH</strong> <strong>M7</strong> topic agreed<br />
September 2010 – CHMP Q&A document updated<br />
November 2010 – First <strong>ICH</strong> EWG <strong>M7</strong> Meeting in Fukuoka Japan<br />
© 2011 <strong>ICH</strong> 5
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