With so much discussion and attention around Nitrosamine safety, it’s essential to trace back and understand well the roots of several ongoing discussions. That took me back to read once again ICH M7, and reflect on the earlier attempts to generate some form of regulatory framework pertaining to mutagenic impurities.
The first public evidence of specific regulatory concern relating to genotoxic impurities was an article published within PharmEuropa in 2000 which called attention to the potential risk of the formation of sulfonate esters resulting from a salt formation process. While meant to be a purely informational article, it is seen as the starting point of Genotoxic Impurities.
In December 2002, the Committee for Proprietary Medicinal Products, acting on behalf of the European Medicines Agency (EMA) Safety Working Party (SWP), took a significant step towards establishing regulations for Medicinal Impurities (MIs) by releasing a position paper explicitly addressing genotoxic impurities. This initial draft position paper holds great importance in retrospect when considering the finalization of the ICH M7 guideline.
Read more about the history of ICH M7 in this editorial article authored by Andrew Teasdale back in 2015 in the ‘Genotoxic Impurities Special Issue’ of OPRD
acs.oprd.5b00311.pdf (125.9 KB)