• Regulatory NewsRegulatory News

    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...
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    ICH releases draft guidelines on analytical method development

    The International Council for Harmonization (ICH) on Thursday issued two draft guidelines that should make it easier for manufacturers to switch analytical methods for testing medicines postapproval and are aimed to promote more robust analytical processes.   The Q14 guideline would harmonize the scientific approaches for analytical procedures development while the Q2(R2) document covers the validation principles for the use of analytical procedures such as near-infrar...
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    Upcoming ICH guidelines should ease post-approval changes for analytical methods

    Two forthcoming guidelines from the International Council on Harmonization (ICH) should make it easier to switch analytical methods for testing medicines post-approval and better manage lifecycle changes, said regulators and industry officials speaking Wednesday at the CMC Strategy Forum sponsored by the California Separation Science Society (CASSS).   At the meeting, an official from the European Medicines Agency (EMA) and industry representatives provided a glimpse o...