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    ICH details milestones reached on guidelines after Athens meeting

    The International Council for Harmonisation (ICH) announced it has reached several milestones over the past year, including advancing guidelines on validating analytical procedures for testing pharmaceuticals and extrapolating adult clinical trial data to the pediatric populations.   The ICH announcement follows its 21-25 May meeting in Athens, Greece which was held in a hybrid format. The meeting included seven working groups, as well as the ICH Management Committee...
  • EMA Regulators Release ICH Guideline on Genotoxic, Carcinogenic Starting Materials

    EU regulators have released for public consultation a guideline under development by the International Conference on Harmonisation (ICH) intended to establish the best practices for controlling carcinogenic risk in pharmaceutical products when those products are made using genotoxic or carcinogenic starting materials. That guideline, M7 Guidelines on Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to limit Potential Carcinogenic Risk ...
  • ICH Manufacturing Impurities Guideline Goes to FDA, EMA, MHLW for Consideration

    The International Conference on Harmonisation (ICH), the international pharmaceutical regulatory harmonization body, has released a draft guidance on the best practices for controlling carcinogenic risk in pharmaceutical products when those products are made using genotoxic or carcinogenic starting materials. That draft guideline, M7: Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceutical to Limit Potential Carcinogenic Risk , is now awaiting ac...