ICH Advances Addendum on Genotoxic Impurities


From DCAT Value Chain Insights (VCI)

By Regulatory News posted 07-14-2015 12:26

  

The International Conference on Harmonization (ICH) reports that its Addendum, "Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk," to ICH M7, "Genotoxic Impurities," reached Step 2b of the ICH Process in June 2015 and now enters the consultation period (Step 3). The M7 Addendum was developed to complement the harmonized ICH M7 Guideline, which was finalized in June 2014, and to provide useful information regarding the acceptable limits of known mutagenic impurities/carcinogenic and supporting monographs.

At Step 2 of the ICH Process, a consensus draft text or guideline, agreed by the appropriate ICH Expert Working Group, is transmitted by the ICH Steering Committee to the regulatory authorities of the ICH regions (European Union, Japan, United States, Canada, and Switzerland) for internal and external consultation, according to national or regional procedures.

Source: ICH

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