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Pharmaceutical Industry and FDA Preparing for ICH M7 Implementation

 
• By Joanne S. Eglovitch

The pharmaceutical industry is concerned about the cost involved in setting up complex computational systems required for evaluating potential genotoxic impurities in drug substances and drug products under ICH M7. The guidance goes into effect in January 2016 for drugs in clinical development and in July 2017 for new and generic drug applications as well as drugs with post-approval changes.

The pharmaceutical industry and FDA are gearing up for implementing the International Conference on Harmonization’s M7 guideline on genotoxic impurities.

The guideline goes into effect on Jan. 1 for drugs in clinical development and in July 2017 for new and generic drugs and for post-approval changes.

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