• 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...
  • Feature ArticlesFeature Articles

    The transition to ICH M10 and its impact on global submissions

    With the expanding globalization of drug development, regulations put forth under the International Council for Harmonisation’s (ICH’s) M10 guidance support the transition to a more harmonized industry. The draft guidance marks another step of integrating international expectations, in this case, as it applies to bioanalytical evaluations. This article examines the key elements of the M10 standard and recommends strategies for successful new drug or clinical trial applicat...
  • Regulatory NewsRegulatory News

    EMA Opens for Consult ICH M10 Guideline on Bioanalytical Method Validation

    The European Medicines Agency (EMA) on Thursday released for public consultation the International Council of Harmonisation’s (ICH) M10 guideline, which aims to help sponsors improve the quality and consistency of bioanalytical data in support of the development and approval of both chemical and biological drugs. The 57-page guidance, which has been in the works since 2016, provides recommendations for the validation of bioanalytical assays for chemical and biological d...